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Tuesday, October 22
8:30am The Next Wave of Cancer Therapies: Allogeneic Cell Therapies and Other Pioneers Amanda Murphy, BTIG; Benjamin Cowen, ImmunoMet Therapeutics; Kanya Rajangam, Nkarta Therapeutics; Gary Lee, Senti Bio; Lalo Flores, Century Therapeutics; Rafael Amado, Allogene show more Session Description As the industry continues to do revolutionary research on cancer, a host of new treatment options for therapies are showing promising data to disrupt the spread of tumors and inching us closer to a world where cancers can be cured. This panel reviews emerging treatment options in cancer, including the next wave of CAR-T, NK cell, and other pioneering approaches, highlighting promises enabled by each and the challenges to be resolved on the path to approvals and helping patients worldwide. Moderator: Amanda Murphy, Managing Director, Research (Biotechnology) Time Tuesday, Oct 22 8:30AM - 9:40AM Speakers Amanda Murphy BTIG Benjamin Cowen ImmunoMet Therapeutics Kanya Rajangam Nkarta Therapeutics Gary Lee Senti Bio Lalo Flores Century Therapeutics Rafael Amado Allogene
9:00am 712 North Marcel Alavi, 712 North, Inc. show more Session Description 712 North is developing personalized mitochondrial medicines to treat a spectrum of diseases either triggered by, or affecting mitochondrial dysfunction. We aim to accelerate the development of treatments for Alzheimer's and cancer by initially targeting well defined orphan genetic diseases in order to quickly provide mechanism-based proof of concept and drug safety/pharmacokinetics data in small and homogeneous patient cohorts. Next, we will leverage this data to achieve quick approval for the initial indication, then use the proof of mechanism and safety data to accelerate trials in the target Alzheimer's population. In the meantime, we are exploring other blockbuster market sized indication for potential targeting of our developed drugs. To maintain capital efficiency, we are aiming to move our initial programs forward with a maximum ratio of non-dilutive funding. 712 North features Dr. Charles Craik, Dr. Frank McCormick and Dr. Michelle Arkin on its Board of Advisors Time Tuesday, Oct 22 9:00AM - 9:15AM Speakers Marcel Alavi 712 North, Inc. Dyve Biosciences Ryan Beal, Dyve Biosciences show more Session Description Dyve has developed a technology that broadly enables transdermal drug delivery. We leverage proven, safe molecules with a delivery challenge to create an efficient and uniquely compelling biotechnology value proposition: fast, de-risked development of novel pharmaceuticals in multibillion-dollar markets. We have human proof of concept data across a range of molecules and indications, have the potential to significantly expand the $30B+ transdermal drug delivery market, and have a scalable drug development and business model. We have clinical programs in gout and melasma which are proving the power and potential of the technology. Time Tuesday, Oct 22 9:00AM - 9:15AM Speakers Ryan Beal Dyve Biosciences IBI Thomas Reeves, IBI show more Session Description IBI is a recent spin out from Interface Biologics, Inc. following the sale of its Surface Modification business. IBI is focused on a novel, non-polymeric, small molecule prodrug platform which provides sustained zero-order release kinetics across a broad range of drug classes and form factors. Our initial product focus is an intravitreal dexamethasone prodrug implant targeting diabetic macular edema, retinal vein occlusion and non-infectious uveitis - collectively a $1B+ market opportunity. The target product profile is to have zero-order drug release for 9-12 months with 1/10th the drug loading of the market leading commercial product with a 30g needle. With strong pre-clinical data and a 505(b)(2) pathway confirmed with the FDA, we are targeting a Phase II clinical trial in mid 2020. Our pipeline product focus areas include other ophthalmic prodrug applications as well as pain management therapies using our steroidal prodrug platform. Time Tuesday, Oct 22 9:00AM - 9:15AM Speakers Thomas Reeves IBI Kymeris Therapeutics Gordon Lee, Kymeris Therapeutics show more Session Description Kymeris Therapeutics is late Discovery Stage firm with an effective Solid Cancer Immunotherapy platform. In 3 years, we achieved Proofs of Principle in 5 pre-clinical murine models of solid cancer, including one preventing metastasis in an I.V. melanoma challenge. Highly potent in inducing Th-I (Cellular Immunity), the platform shows reprogramming of the Tumor Microenvironment ("Cold"​ tumors turn "hot"​). It has been also been engineered to target cancer, express or secrete proteins of therapeutic interest. Research in France guided by US ex-head of oncology at 3 major pharma. With support from top US immune-oncology luminaries, we are poised to select our lead pre-IND candidate and also seek co-development to vector/combine with a partner's agent. Our platform is based on non-pathogenic organisms (only recently identified) to which Kymeris has exclusive global rights in oncology. We plan future Clinical Development in the USA and seek investors and potential partn Time Tuesday, Oct 22 9:00AM - 9:15AM Speakers Gordon Lee Kymeris Therapeutics Rezolute Keith Vendola, Rezolute show more Session Description Rezolute is a clinical-stage biotechnology company developing transformative therapies targeting rare and metabolic diseases. Time Tuesday, Oct 22 9:00AM - 9:15AM Speakers Keith Vendola Rezolute
9:15am Abreos Biosciences, Inc. Bradley Messmer, Abreos Biosciences show more Session Description Abreos Biosciences is planning to develop a novel therapeutic for treatment of multiple sclerosis, a chronic neurological disease. Our approach will be to study a well characterized biologic in a new indication facilitated by our platform for precision personalized dosing. Time Tuesday, Oct 22 9:15AM - 9:30AM Speakers Bradley Messmer Abreos Biosciences AxeroVision, Inc. Achim Krauss, AxeroVision, Inc. show more Session Description AxeroVision, a privately held biotechnology and GSK spinout company, based in Carlsbad, CA, is developing next generation therapeutics for the treatment of Dry Eye Disease (DED) and other ophthalmic inflammatory diseases. The main investors are Laboratoires Théa and GSK. Lead assets are AXR-159, a VLA-4 integrin antagonist being developed for the treatment of moderate to severe dry eye disease and with an acute onset of action in a phase 2a clinical study; and AXR-270, a highly potent and selective, pharmacologically differentiated corticosteroid in a proprietary once-daily topical ocular delivery formulation, with an expected IND filing in 2019. Time Tuesday, Oct 22 9:15AM - 9:30AM Speakers Achim Krauss AxeroVision, Inc. Drusolv Therapeutics John Edwards, Drusolv Therapeutics show more Session Description Drusolv Therapeutics is a clinical-stage drug company based in Philadelphia. We are developing a novel, high-dose statin for early intervention in a blinding eye disease called age-related macular degeneration (AMD). AMD is the leading cause of blindness in developed countries, affecting more people than glaucoma and diabetic retinopathy combined. Our product, Ocustatin™, is aimed at patients who are still in the intermediate stage of the disease and currently have very limited options to prevent progression to late-stage vision loss. This is a $4B per year, completely unmet need. Ocustatin was developed at Harvard University and has been validated in a very successful proof-of-concept clinical trial that showed a 75% reduction in progression to late-stage blindness. John Edwards, the founder and CEO of Drusolv, is a serial entrepreneur with extensive experience in AMD. Time Tuesday, Oct 22 9:15AM - 9:30AM Speakers John Edwards Drusolv Therapeutics Hexagon Bio Maureen Hillenmeyer, Hexagon Bio show more Session Description Hexagon Bio is turning the world’s DNA data into new medicines. Our proprietary platform combines a large-scale sequencing program, data science and synthetic biology to discover target-specific therapies. We are focused on oncology and anti-infectives, especially cancer metabolism, synthetic lethal vulnerabilities, and “undruggables” such as RAS and protein-protein interactions. We have 8 preclinical programs in oncology and one preclinical antifungal program, which we are pursuing towards clinical trials. Time Tuesday, Oct 22 9:15AM - 9:30AM Speakers Maureen Hillenmeyer Hexagon Bio ISOThrive LLC Jack Oswald, ISOThrive LLC show more Session Description ISOThrive is a microbiome inspired therapeutics company that has developed a novel patented and patents-pending treatment targeting gastroesophageal reflux disease (a.k.a. GERD or chronic acid reflux). Our unique carbohydrate is designed to restore the normal localized microbiome at the lower esophageal sphincter, and thereby stop acid reflux at the root cause. In addition, there is growing evidence that suggests that the abnormal microbiome that exists with GERD, and the chronic inflammation that results, may be the cause of the progression of GERD to Barrett’s Esophagus and ultimately to cancer of the esophagus. By restoring the normal local microbiome, ISOThrive may also prevent esophageal cancer. ISOThrive’s microbiome inspired platform addresses many other indications including IBS and colorectal cancer. Time Tuesday, Oct 22 9:15AM - 9:30AM Speakers Jack Oswald ISOThrive LLC
9:30am Interpace Diagnostics Jack Stover, Interpace Diagnostics show more Session Description Interpace is a leader in enabling personalized medicine, offering advanced diagnostics, and providing molecular markers, data solutions and biopharma services. Our new business model leverages disease-specific, unique data and specialized service offerings along the therapeutic value chains from early diagnosis and prognostic planning to targeted therapeutic applications. Time Tuesday, Oct 22 9:30AM - 9:45AM Speakers Jack Stover Interpace Diagnostics Riptide Bioscience, Inc. Charles Garvin, Riptide Bioscience, Inc. show more Session Description Riptide is a late preclinical-stage biotechnology company developing novel peptide therapeutics for macrophage-driven cancers and fibrosis. Riptide’s drug candidates are highly effective in syngeneic tumor models driven by a suppressive tissue microenvironment (pancreatic, prostate, breast, colon). Treatment with Riptide drug candidates transforms tumors with minimal immune cell infiltrate to tumors with elevated levels and activity by T, NK, and B cells. - Peer-reviewed contract and grant support has been awarded by the National Cancer Institute, the Defense Department, Scleroderma Research UK, and the Rosetrees Trust. - Highest efficacy ever demonstrated in NCI’s KRAS/p16 transgenic model of pancreatic cancer. - Superior efficacy to chemotherapy and checkpoint inhibitor as monotherapy, and complementary as combination therapy. - Efficacy also shown in models of macrophage-driven pulmonary fibrosis, superior to the FDA-approved drugs, perfenidone and nintedanib. Time Tuesday, Oct 22 9:30AM - 9:45AM Speakers Charles Garvin Riptide Bioscience, Inc. Univfy Mylene Yao, Univfy show more Session Description Univfy is a proprietary, cloud-based, AI/ML platform that significantly improves patients’ experience when navigating treatment options. Leveraging proprietary, AI-predicted treatment outcomes specific to unique patient populations, the Univfy AI/ML Platform works with providers/pharma to develop and validate treatment-specific prognostics models. The goal is to utilize prognostic tiers to provide accurate, personalized prognostics and design pricing programs that make personalized treatments affordable to payers while greatly increasing access to therapeutics. We have established compelling proof points in the fertility space and aim to apply the Univfy AI platform to improve patients' experience in other disease areas. Time Tuesday, Oct 22 9:30AM - 9:45AM Speakers Mylene Yao Univfy VISTARA BIOSCIENCE LLC GIRISH NALLUR, VISTARA BIOSCIENCE show more Session Description Vistara Bioscience is developing proteomics processess and bioinformatics for detecting networks of proteins and accessory factors which are in close collaboration with proteins of clinical interest. The networks serve as biomarker panels to follow along the drug discovery process, and additional-ly, may suggest combinatorial targets or new ones. Vistara expects to offer Services to pharma and biotech partners for drug discovery, candidate profiling, and molecular phenotyping applications with initial focus in Oncology, Infectious Diseases and CNS disease areas. Time Tuesday, Oct 22 9:30AM - 9:45AM Speakers GIRISH NALLUR VISTARA BIOSCIENCE Vybion, Inc Lee Henderson, Vybion, Inc show more Session Description Clinical stage developer of Gene Therapies for neurodegenerative diseases with a new drug class asset and a platform for further discovery. Vybion has developed an Intrabody (intracellular antibody scFv fragment), called INT41, for Huntington's disease that when delivered by rAAV in an animal model delays motor function and cognitive loss. The mechanism of action is the elimination of the N-terminal toxic fragment that drives gene dysregulation and neuron loss. The Company has developed the IND enabling program following discussions with the FDA and has received Orphan Drug Designation for the FDA as well. INT41 is also the lead candidate for Gene Therapy in spinal muscular atrophy (SMA) and spinal cerebellar ataxia (SCA) 1, 3 and 7. Additional neurodegenerative disease development with similar accumulation protein fragments due to a breakdown in proteostasis include amyotropic lateral sclerosis (ALS) and frontal temporal dementia (FTD). The company operates virtually. Time Tuesday, Oct 22 9:30AM - 9:45AM Speakers Lee Henderson Vybion, Inc
9:45am 360Medlink Jean-Manasse Theagene, 360Medlink show more Session Description At 360Medlink, we are committed to delivering evidence-based innovations that transform health care for all people. Rooted in our experience in clinical care, behavioral medicine, and with vulnerable populations, we deploy impactful patient-centered digital health therapeutics tailored to the population need. Time Tuesday, Oct 22 9:45AM - 10:00AM Speakers Jean-Manasse Theagene 360Medlink Engine Biosciences Jeffrey Lu, Engine Biosciences show more Session Description Engine Biosciences is a platform-based drug discovery company at the intersection of computation and high-throughput biological experimentation, leveraging technology from its co-founders, leading professors in systems and synthetic biology at MIT, UCSD, and Mayo Clinic. Engine has a computational and machine learning platform that is tightly coupled with a patented high-throughput combinatorial gene perturbation platform, CombiGEM, for rapid predictions and validation of new targets, biomarkers, and synthetic lethal interactions, and capabilities to develop drugs directed at novel biology. Engine’s platform has received issued patents and has been published in leading journals like Science, Cell, and Nature Biotechnology. Engine is currently working in oncology, CNS, and dermatology internally and in Fortune 500 company collaborations. Engine is led by a team of experienced company builders, drug discovery veterans, data scientists and engineers in SF Bay Area and Singapore. Time Tuesday, Oct 22 9:45AM - 10:00AM Speakers Jeffrey Lu Engine Biosciences Leidos James Pannucci, Leidos show more Session Description Leidos is a recognized global leader in solving important problems in defense, civil, intelligence, homeland security, and health. Explorations in Global Health (ExGloH) is a new division of Leidos Health focused on developing methods that prove effective in not only treating cancer but for safe application in infectious disease vaccines. Building on our deep understanding of infectious disease vaccine development and cancer therapeutics from decades of product development support for our federal customers, we have created an effective platform for discovering novel peptide scaffolds. Our lead candidate has been designed to simultaneously antagonize two members of the CD28 checkpoint receptor family, PD1 and CTLA4. Time Tuesday, Oct 22 9:45AM - 10:00AM Speakers James Pannucci Leidos Orthopaedic Research and Education Foundation Lee Grossman, Orthopaedic Research and Education FOundation show more Session Description The Orthopaedic Research and Education Foundation (OREF) is the leading independent funder of orthopaedic research. Throughout our history, we have awarded over 4700 grants worth approximately $150 Million covering all aspects of orthopaedics. OREF’s programs and resources enable it to make significant contributions to the field of orthopaedic research. In addition to funding research, OREF’s strengths lie in its ability to:leverage the knowledge, experience and resources of the orthopaedic community to support cutting edge research;bring together investigators, surgeons from more than 50 orthopaedic sub specialties and industry partners to identify and fund the most important issues in orthopaedics; foster the development of new generations of investigators through research-focused educational programs; and bring innovation to the forefront of one of the most significant and fastest growing specialties in healthcare. Time Tuesday, Oct 22 9:45AM - 10:00AM Speakers Lee Grossman Orthopaedic Research and Education FOundation Private Investors' Incubators for University-Sourced Ideas Catherine Vorwald, The Labs by Sterling Bay; Mark S. Blumenkranz , Lagunita Biosciences; Jennifer Cochran, xCella Biosciences; Chris Garabedian, Xontogeny; Portfolio Manager—Venture, Perceptive Advisors; Julie Gilmore, Eli Lilly and Company; Kevin Grimes, Stanford University; Satish Jindal, BioMotiv show more Session Description Recognizing a persistent “valley of death” in funding for medical research past the government-grant stage, several organizations have recently launched specialized investment vehicles. These vehicles are specifically designed to support translational research for university-sourced ideas to become independent companies capable of moving biological ideas into human drug development and to attract conventional venture investors. Hear from investors, academics, and entrepreneurs pursuing these new approaches that resolve critical bottlenecks as they work to lower initial project risks and accelerate progress through proof-of-concept. Time Tuesday, Oct 22 9:45AM - 10:40AM Speakers Catherine Vorwald The Labs by Sterling Bay Mark S. Blumenkranz Lagunita Biosciences Jennifer Cochran xCella Biosciences Chris Garabedian Xontogeny; Portfolio Manager—Venture, Perceptive Advisors Julie Gilmore Eli Lilly and Company Kevin Grimes Stanford University Satish Jindal BioMotiv Serimmune, Inc. Noah Nasser, Serimmune, Inc. show more Session Description Serimmune is an immune intelligence company focused on providing a holistic view of adaptive immune response and identifying critical immune factors in disease and health. Central to our efforts is the Serum Epitope Repertoire Analysis (SERA) platform that combines bacterial display peptide libraries, next generation sequencing, machine learning and custom bioinformatics to reveal the many diverse antigens stimulating the adaptive immune system. Serimmune leverages these data to build our human immunity map, a growing database that can be interrogated to characterize immunity and immune responses, enabling development of next generation diagnostics, vaccines and therapeutics. The company is actively pursuing commercial partnerships around the SERA platform and has a number of ongoing collaborations with government, academic and commercial organizations. The company was founded in 2014 and is backed by investors including Illumina Ventures, LabCorp, and Merck. Time Tuesday, Oct 22 9:45AM - 10:00AM Speakers Noah Nasser Serimmune, Inc.
10:00am Cytovia Therapeutics Daniel Teper, Cytovia Therapeutics show more Session Description Cytovia is dedicated to the development of transformational cancer immunotherapies, addressing several of the most challenging unmet medical needs including the prevention of cancer relapse and metastasis. Cytovia focuses on Natural Killer (NK) cell biology and applies precision medicine tools to develop the right therapy for the right patient at the right stage of the disease. Cytovia has secured access to multiple advanced technologies, including allogeneic cell therapy, multispecific antibodies, and cytokines. Cytovia establishes development partnerships to accelerate time-to-market and commercialization alliances in order to optimize rapid adoption of its novel immunotherapies. Time Tuesday, Oct 22 10:00AM - 10:15AM Speakers Daniel Teper Cytovia Therapeutics GLAdiator Biosciences Terry Hermiston, GLAdiator Biosciences show more Session Description We are an early stage research company developing a platfrom for the detection and treatment of diseased cells using the detection of phophatidylserine (PS) on the cell surface to detect and target these cells. Based on a naturally occurring PS targeting motif (the Gla domain) this platform was acquired in 2018 from Bayer HealthCare and validated in collaboration with Stanford University School of Medicine. We are seeking to close out our seed funding and to identify a clinical candidate in 12-18 months. Time Tuesday, Oct 22 10:00AM - 10:15AM Speakers Terry Hermiston GLAdiator Biosciences Kineta, Inc. Shawn Iadonato, Kineta, Inc. show more Session Description Kineta, Inc. is a clinical stage biotechnology company committed to developing disruptive life science technologies that address unmet patient needs. We have leveraged our expertise in immunology to advance a focused pipeline of investigational drugs in immuno-oncology, neuroscience and biodefense. RIG-I Immuno-oncology: Disruptive small molecule technology to turn cold tumors hot. Neuroscience: a novel non-opioid to treat chronic pain. Biodefense: a first-in-class antiviral treatment to treat Lassa fever and other arenaviruses We actively collaborate with a broad array of industry, government and academic partners to advance our innovative research. - $520M RIG-I immuno-oncology strategic partnership with Pfizer - $359M chronic pain strategic partnership with Genentech - $9M Translation Fund Award from the Wellcome Trust for LHF-535 Kineta, Inc. is raising $40 million in a crossover funding round in the second half of 2019 and planning for a public market offering in 2020. Time Tuesday, Oct 22 10:00AM - 10:15AM Speakers Shawn Iadonato Kineta, Inc. NeuroScientific Biopharmaceuticals Ltd Anton Uvrov, Neuroscientific Biopharmaceuticals show more Session Description NeuroScientific Biopharmaceuticals Ltd (NSB) is an Australian-based emerging biotech company developing novel peptide therapeutics for the treatment of neurodegenerative conditions. Our lead drug candidate, EmtinB, is a neuroprotective and neuroregenerative peptide most advanced as a disease modifying treatment for Alzheimer's disease. Additionally, EmtinB is being developed as a treatment for glaucoma due to its ability to protect and regenerate the optic nerve. EmtinB is an agonist of the LRP-1 receptor which is expressed by neuronal cells of both the CNS and PNS, offering a novel MOA for the treatment of neurodegenerative conditions and the potential to be a first-in-class therapeutic. In addition to EmtinB, NSB has a pipeline of therapeutic peptides. Time Tuesday, Oct 22 10:00AM - 10:15AM Speakers Anton Uvrov Neuroscientific Biopharmaceuticals Tierra Biosciences Zachary Sun, Tierra Biosciences show more Session Description Tierra Biosciences (formerly Synvitrobio, Inc.) is a VC-backed startup leveraging cell-free synthetic biology, automation, computer learning, and metagenomics to identify new molecules and new chemistry from Nature’s genetic datasets. Time Tuesday, Oct 22 10:00AM - 10:15AM Speakers Zachary Sun Tierra Biosciences
10:15am Anima Biotech Inc. Yochi Slonim, Anima Biotech Inc. show more Session Description Anima Biotech is advancing Translation Control Therapeutics, the first and only platform for the discovery of small molecule drugs that specifically control mRNA translation as a new strategy against hard and undruggable targets in many diseases. Anima’s proprietary technology enables visualization and monitoring of target protein translation via pulses of light emitted by ribosomes. The fully automated high-throughput screening system discovers small molecules that modulate the light, as they decrease or increase the target protein’s production. The platform integrates proprietary technologies in biology, bioinformatics, image analysis, big data analysis and artificial intelligence algorithms in a cloud computing software architecture. Time Tuesday, Oct 22 10:15AM - 10:30AM Speakers Yochi Slonim Anima Biotech Inc. Cantabio Pharmaceuticals Gergely Toth, Cantabio Pharmaceuticals show more Session Description Cantabio Pharmaceuticals is a preclinical stage biotechnology company focusing on the research and development of disease modifying therapeutics candidates for Alzheimer’s disease (AD), Parkinson’s disease (PD) and Type II diabetes (T2D). Cantabio is targeting the reduction of biochemical stress such as oxidative and glyoxal stress and protein aggregation, which are believed to be some of the main causes of these diseases. Cantabio’s research strategy integrates a detailed therapeutic focus, target family biophysics, and drug discovery technology and expertise into an innovative drug discovery approach to develop small molecule pharmacological chaperones for clinical trials. Cantabio is developing the following therapeutic programs: (1) CB101: small molecule pharmacological chaperones targeting the DJ-1 protein for PD; (2) CB201: engineered cell-penetrant DJ-1 protein for T2D; (3) CB301: small molecule pharmacological chaperones targeting the Tau protein for AD. Time Tuesday, Oct 22 10:15AM - 10:30AM Speakers Gergely Toth Cantabio Pharmaceuticals Landos Biopharma Josep Bassaganya-Riera, Landos Biopharma show more Session Description Landos Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of first-in-class, oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a first-in-class, oral therapeutic that acts locally in the gastrointestinal tract for treatment of inflammatory bowel disease (IBD). Landos completed a $60 million Series B financing round in August of 2019. The company has completed Phase 1 clinical testing, initiated Phase 2 clinical testing of BT-11 for ulcerative colitis and plans a Phase 2 trial in Crohn’s disease in 2019. Landos also has a robust pipeline of new compounds for other autoimmune diseases in preclinical and IND-enabling stages, several of which will advance to clinical stage in 2020. Time Tuesday, Oct 22 10:15AM - 10:30AM Speakers Josep Bassaganya-Riera Landos Biopharma OncoSenX Matthew Scholz, OncoSenX show more Session Description OncoSenX is a late stage pre-clinical cancer company headquartered in Seattle, Washington. Our platform allows us to target solid tumors based on transcriptional activity using a unique lipid nanoparticle and plasmid DNA. The DNA encodes an inducible death protein under a promoter that is active in the tumor. The first therapeutic we will take into the clinic targets cells with elevated levels of the tumor suppressor p53. Our novel LNP delivery technology allows us to administer high doses systemically and multiple times. The LNPs are non-immunogenic and well tolerated at doses far higher than the maximum expected human equivalent dose in rodents and non-human primates. Our advanced constructs also encode immunotherapeutic proteins. We have successfully used these to induce immune-mediated tumor ablation in animal models and plan to perform studies in tumors that are refractory to checkpoint inhibitors. Time Tuesday, Oct 22 10:15AM - 10:30AM Speakers Matthew Scholz OncoSenX OrphoMed, Inc. Nikhilesh Singh, OrphoMed, Inc. show more Session Description OrphoMed is a clinical-stage biotechnology company with a proprietary dimer therapeutics platform. The company is focused on developing best-in class treatments for patients with gastrointestinal disorders. Time Tuesday, Oct 22 10:15AM - 10:30AM Speakers Nikhilesh Singh OrphoMed, Inc.
10:30am Antidote Laurent Schockmel, Antidote show more Session Description Antidote is a digital health company on a mission to accelerate medical research. In a world where 80% of clinical trials are delayed or closed due to lack of participants, Antidote uses precision recruitment to match the right patients with the right trials. Antidote strikes the right balance between technology and human touch to deliver high-quality patient engagement through the integration of data-driven technologies, digital expertise, deep domain experience, a diverse partner network, and personalized patient and site services. Antidote was launched as TrialReach and is based in the US and UK. For more information, please visit Time Tuesday, Oct 22 10:30AM - 10:45AM Speakers Laurent Schockmel Antidote BioXcel Therapeutics Vimal Mehta, BioXcel Therapeutics show more Session Description BioXcel Therapeutics is a clinical stage biopharmaceutical company focused on drug development in neuroscience and immuno-oncology utilizing artificial intelligence. Currently the company has two lead clinical development programs: o BXCL501, a sublingual thin film formulation designed for acute treatment of agitation resulting from neurological and psychiatric disorders • Reported positive results from Phase 1b trial of intravenously-dosed Dexmedetomidine supporting BXCL501 development in schizophrenia • Data from Phase 1b PK/PD safety study in mild probable Alzheimer’s patients expected in second half of 2018 o BXCL701, an immuno-oncology agent designed for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer • Announced FDA acceptance of IND for treatment emergent neuroendocrine prostate cancer; study expected to be initiated in fourth quarter of 2018 • Entered clinical partnership with Nektar for study in pancreatic cancer Time Tuesday, Oct 22 10:30AM - 10:45AM Speakers Vimal Mehta BioXcel Therapeutics ImmunoMet Therapeutics Benjamin Cowen, ImmunoMet Therapeutics show more Session Description ImmunoMet is a clinical stage biotech targeting cellular metabolism to develop novel anti-tumor and anti-fibrotic therapies. Our lead molecule, IM156, is an OXPHOS inhibitor with demonstrated impressive in-vivo efficacy in resistant solid tumors. IM156 is currently in Phase 1 with a good safety profile and is expected to progress into Phase 2 in 2020. We have initiated a second program in fibrosis. Immunomet also owns a large library of biguanides with the potential to develop, or partner, new products. The company was founded in 2015, is headquartered in the Houston JLABs near MD Anderson, and has raised $20M to date. Time Tuesday, Oct 22 10:30AM - 10:45AM Speakers Benjamin Cowen ImmunoMet Therapeutics RubrYc Therapeutics, Inc. Isaac Brigth, RubrYc Therapeutics, Inc. show more Session Description Founded in 2017, RubrYc Therapeutics, Inc. integrates massively parallel in silico simulation and empirical analyses of protein structures to address long-standing challenges in biotherapeutic discovery. In therapeutic antibody discovery, epitopes matter. Our platform enables a non-conventional approach that uniquely enriches discovery campaigns with therapeutic antibody candidates that are on target, on epitope, and optimized for the prescribed mode of action. RubrYc Therapeutics emerged as a spin-out from HealthTell, Inc. in April 2018. RubrYc has partnered with Third Point Ventures, iCarbonX, Paladin Capital, and Vital Venture Capital to complete its Series A financing. To date, the RubrYc team has also engaged 2 of the top 20 global biopharmaceutical companies in collaborations. RubrYc Therapeutics is located in San Carlos, CA, and currently has 10 employees. Time Tuesday, Oct 22 10:30AM - 10:45AM Speakers Isaac Brigth RubrYc Therapeutics, Inc. Xoc Pharmaceuticals, Inc. Scott Borland, Xoc Pharmaceuticals, Inc. show more Session Description Xoc Pharmaceuticals is an early-stage, biopharmaceutical company focused on the development of innovative therapeutics. We design novel products “from the ground up” by leveraging information on existing compounds with established pharmacological and clinical history and utilizing the Company’s proprietary design and development process to address unmet medical needs, primarily in the CNS disease space. Time Tuesday, Oct 22 10:30AM - 10:45AM Speakers Scott Borland Xoc Pharmaceuticals, Inc.
10:45am Abalone Bio, Inc. Richard Yu, Abalone Bio, Inc show more Session Description Abalone Bio is a seed-stage GPCR antibody therapeutics platform company, first focusing on meeting unmet needs in fibrosis, neuropathic pain, polycystic kidney disease, and rare cancers. Abalone Bio has developed a functional GPCR antibody discovery platform with the unique ability to find ultra-rare modulators- not just blockers- of GPCR function, such as agonists. Its first preclinical-stage antibody candidate is a potent and selective agonist of a human cannabinoid receptor with applicability in a number of indications. Abalone Bio is an NSF Phase I and Phase II SBIR awardee. Time Tuesday, Oct 22 10:45AM - 11:00AM Speakers Richard Yu Abalone Bio, Inc Amygdala Neurosciences Peter Strumph, Amygdala Neurosciences Inc. show more Session Description Amygdala is developing ANS-6637, a selective ALDH2 enzyme inhibitor, as a treatment for opioid, alcohol and nicotine addiction. With a mechanism of action in the brain (published in Nature Medicine) that prevents pathophysiologic dopamine surge without changes to basal dopamine, ANS-6637 intervenes in the reward circuit to prevent cue-based craving and drug seeking behavior. ANS-6637 is different than any other approved or development treatment in for addiction: it does not have abuse liability, is not a agonist (like buprenorphine), is not an antagonist (like naltrexone), is not a scheduled compound, and ANS-6637 can be used alone or in combination with current pharmacotherapy and behavior-based addiction treatments. ANS-6637 safety and efficacy is being evaluated in Phase 2 POC studies for Opioid Use Disorder and Alcohol Use Disorder and plans are being finalized for for additional Phase-2 POC studies for Smoking Cessation and PTSD. Time Tuesday, Oct 22 10:45AM - 11:00AM Speakers Peter Strumph Amygdala Neurosciences Inc. BridGene Biosciences, Inc. Ping Cao, BridGene Biosciences, Inc. show more Session Description BridGene is a Biotech company founded by Dr. Chao Zhang based on his well recognized research in Chemical Genetics, Covalent Kinase Inhibitor, and Chemical Proteomics. We are blessed with scientific guidance from three world-class Scientific Advisors: Dr. Kevan Shokat, Dr. Arthur Weiss (Both are Member of NAS, NAM, and AAAS) and Dr. Ariel Warshel (Nobel Laureate). BridGene focuses on the discovery of small-molecule covalent inhibitors for targets in the fields of Oncology, Immunology, and Neurodegenerative Diseases. We have an innovative discovery platform called IMTAC that shares some similarities with Vividion Therapeutics‘s platform, but has some advantages. IMTAC can be used to (i) discover ligands for "unliganded" or "undruggable" targets; (ii) largely reduce the time and cost of lead discovery; (iii) identify additional targets of drugs or clinical candidates; (iv) create a unique ligand-target interaction database to guide small molecule drug design. Time Tuesday, Oct 22 10:45AM - 11:00AM Speakers Ping Cao BridGene Biosciences, Inc. Gene Therapies: The Pipeline Towards a New Era for Patients Michelle Gilson, Canaccord Genuity Inc.; Gary Lee, Senti Bio; Michael Narachi, CODA Biotherapeutics; Shyam Patel, California Institute for Regenerative Medicine (CIRM) show more Session Description Gene therapies have the potential to increase the healthspan of patients and offer new approaches to treating diseases, with a sizable pipeline in development. Early leaders in the field have focused on rare diseases which continues to open the pathway for other treatments in oncology and infectious and chronic diseases. Attend this session to hear about successful approaches, challenges in protein delivery, and the future of expanding this class of medicines. Time Tuesday, Oct 22 10:45AM - 11:40AM Speakers Michelle Gilson Canaccord Genuity Inc. Gary Lee Senti Bio Michael Narachi CODA Biotherapeutics Shyam Patel California Institute for Regenerative Medicine (CIRM) SciBac Inc. Jeanette Mucha, SciBac Inc. show more Session Description SciBac is a preclinical company located in Burlingame, CA. SciBac creates rEvolutionary live biotherapeutics that treat and prevent chronic lung infections in cystic fibrosis and beyond. At SciBac, we design our biologics for increased efficacy and survival using our MERGE technology. Each microbe has multiple modes of action including direct killing and biofilm removal to increase efficacy and reduce the possibility of resistance. Our first lung therapeutic, Aeruguard, removes Pseudomonas, Staph, and Burkholderia lung infections while Mybacguard, a different biologic, removes Non-tuberculous Mycobateria (NTM) where the pathogens hide. Both therapeutics have the potential to be used for multiple indications outside of CF including branchiectasis, VAP, non-CF lung infections, Acinetobacter infections, skin infections, and sinusitis. We have raised $1.95M including investment from Breakout Labs and iSelect Fund, brought in $300k of revenue from industrial projects, and $1M in grants. Time Tuesday, Oct 22 10:45AM - 11:00AM Speakers Jeanette Mucha SciBac Inc. Summit Therapeutics Glyn Edwards, Summit Therapeutics show more Session Description Summit Therapeutics is a leader in antibiotic innovation. Our new mechanism antibiotics are designed to become the new standards of care for the benefit of patients and create value for payors and healthcare providers. We are currently developing new mechanism antibiotics for infections caused by C. difficile, N. gonorrhoeae and Enterobacteriaceae and are using our proprietary Discuva Platform to expand our pipeline. Time Tuesday, Oct 22 10:45AM - 11:00AM Speakers Glyn Edwards Summit Therapeutics
11:00am Adjuvance Technologies Inc. Tyler Martin, Adjuvance Technologies show more Session Description Adjuvance Technologies is advancing synthetic saponin vaccine adjuvants for infectious disease, immuno-oncology and other applications. Our lead project is TQL1055, an optimized analogue of the saponin adjuvant QS-21, which is a critical component of the AS01 adjuvant used in the zoster vaccine commercialized by GSK. Among the improved attributes of 1055, are ample supply and improved tolerability, both of which are substantial issues for QS-21 and Shingrix. Adjuvance has received $4M of NIH funding to date, and recently closed a $20M Series A round. This funding will enable us to get 1055 through a phase 1/2 clinical trial in infectious disease, and also allow us to explore other indications such as immuno-oncology and neurobiology. Time Tuesday, Oct 22 11:00AM - 11:15AM Speakers Tyler Martin Adjuvance Technologies Circumvent Andrew Lim, Circumvent show more Session Description Circumvent is developing medicines for rare, genetically defined forms of neurodegenerative disease. We have a lead program that is in IND-enabling studies for CLN1 Disease, which due to a well established natural history and defined patient population, provides a quick path to a pivotal trial and registration/market. The active component of the drug that Circumvent is developing has been exposed to 1000s of patients and has a well defined safety profile. In addition, Circumvent is utilizing key insights derived from the biology of rare, genetically defined forms of neurodegenerative disease to identify key nodes driving disease progression in sporadic, complex forms of disease such as Alzheimer’s, Huntington’s, and Parkinson’s. Circumvent has been able to utilize these key insights to develop several earlier stage program including targets in autophagy and cellular homeostasis. Time Tuesday, Oct 22 11:00AM - 11:15AM Speakers Andrew Lim Circumvent Epilepsy Foundation Sonya Dumanis, Epilepsy Foundation show more Session Description The Epilepsy Foundation is leading the fight to END EPILEPSY®. With a network of nearly 50 partners throughout the United States, the Foundation connects people to treatment, support and resources; leads advocacy efforts; funds innovative research and the training of specialists; and educates the public about epilepsy and seizure first aid. Our research priorities are to drive therapeutic innovation, change outcomes, and save lives. Time Tuesday, Oct 22 11:00AM - 11:15AM Speakers Sonya Dumanis Epilepsy Foundation Exicure David Snyder, Exicure show more Session Description Exicure, Inc. is a clinical stage biotechnology company developing a new class of immunomodulatory and gene regulating drugs against validated targets. Exicure's proprietary spherical nucleic acid (SNA™) architecture is designed to unlock the potential of therapeutic oligonucleotides in a wide range of cells and tissues. Exicure's lead programs address inflammatory diseases, genetic disorders and oncology. Exicure is based outside of Chicago, IL. Time Tuesday, Oct 22 11:00AM - 11:15AM Speakers David Snyder Exicure Zenopharm, LLC Guangdi Wang, Zenopharm, LLC show more Session Description Zenopharm is a startup founded in 2012 to commercialize innovative oncology therapeutics based on its patented platform technology. ZB716 is an oral SERD developed to overcome clinical limitations of fulvestrant, including poor bioavailability, injection-related side effects, slow therapeutic action due to long time-to-steady state drug concentration, and low clinical response rate. ZB716 effectively enhances systemic drug exposure while bypassing first-pass metabolism of fulvestrant. In both wild type ER+ and ER mutant breast cancer cells, ZB716 blocks ER transcriptional activities, cell proliferation and degrades ER in a dose-dependent manner. Moreover, ZB716 has far superior oral bioavailability compared to fulvestrant and greater efficacy in blocking tumor growth in patient derived xenograft (PDX) breast cancer models. Zenopharm received SBIR Phase I and II awards to conduct IND-enabling studies of ZB716 to move towards a first in human clinical trial. Time Tuesday, Oct 22 11:00AM - 11:15AM Speakers Guangdi Wang Zenopharm, LLC
11:15am EnterTroy Bio John Boockvar, EnterTroy Bio show more Session Description EnterTroy Bio is a company whose mission is to safely overcome the Blood Brain Barrier (BBB). Our “BBB Permeability Kit” contains novel drugs and devices that have been extensively studied by our clinical and basic science research teams. These teams are the world leaders in intra-arterial drug delivery with blood brain barrier disruption with over a decade’s worth of experience in pre-clinical modeling and human clinical trials. This proprietary kit provides all the microcatheters, pumps and syringes and drugs to perform intra-arterial blood brain barrier disruption and delivery of drugs to the brain. Our hope is to provide the end-user with all of the supplies necessary to not only safely perform intra-arterial drug delivery to the brain but to regulate BBB permeability for the delivery of therapeutic agents past the BBB. While important for the treatment of cancers to the brain, this kit will have a wide applicability to the treatment of a host of CNS disorders. Time Tuesday, Oct 22 11:15AM - 11:30AM Speakers John Boockvar EnterTroy Bio First Light Diagnostics David Macdonald, First Light Diagnostics show more Session Description The World’s only platform that can get patients on the right antibiotic therapy at the onset of their multi-drug resistant infection. Clinical studies demonstrate ultra-sensitivity and specificity. Accurate determination of effective antibiotics for multi-drug resistant infections in just 4 hours without culture, vs. 4 days. Detection of pathogens and toxins in 30 minutes. C. difficile study published in a top peer reviewed scientific journal. FDA submission Q3 2019, with clearance expected in Q1 2020. Time Tuesday, Oct 22 11:15AM - 11:30AM Speakers David Macdonald First Light Diagnostics MaxCyte, Inc. Douglas Doerfler, MaxCyte, Inc. show more Session Description CARMA(TM) is an mRNA-based proprietary therapeutic platform for autologous cell therapy for the treatment of solid cancers. The CARMA therapeutic platform utilizes PBMCs and can be manufactured in one day; dramatically reducing the time, complexity and cost of autologous cell therapies. MCY-M11, the first CARMA drug candidate, is a mesothelin-targeting CAR therapy being tested in a Phase I clinical trials in individuals with relapsed/refractory ovarian cancer and peritoneal mesothelioma. In addition, through its life sciences business, MaxCyte leverages its Flow Electroporation® Technology to enable its biopharma partners to advance the development of innovative medicines, particularly in cell therapy. MaxCyte has placed its instruments worldwide, including with all top 10 global biopharmas. The Company now has 80+ partnered program licenses in cell therapy with 45+ licensed for clinical use. Time Tuesday, Oct 22 11:15AM - 11:30AM Speakers Douglas Doerfler MaxCyte, Inc. Sapience Therapeutics, Inc. Barry Kappel, Sapience Therapeutics show more Session Description Sapience Therapeutics is focused on discovering and developing peptide-based therapeutics to previously ‘undruggable’ targets for major unmet medical needs, particularly high mortality cancers. With platform-based discovery capabilities, we generate novel peptides to disrupt protein:protein interactions with a focus on disruption of oncogenic transcription complexes, signaling pathways and immune-modulatory mechanisms. We have an emerging pipeline of drug candidates targeting important oncogenic proteins, such as C/EBPβ, β-catenin, and cJun, which have opportunities to address solid tumors and hematologic malignancies, including breast cancer, melanoma, GBM, lung cancer and AML. Time Tuesday, Oct 22 11:15AM - 11:30AM Speakers Barry Kappel Sapience Therapeutics SHINKEI Therapeutics GP Singh, SHINKEI Therapeutics show more Session Description • SHINKEI is a CNS (Central Nervous System) disorders focused pharmaceutical company using the 505b2 regulatory strategy to redevelop existing pharmaceutical products for faster and better patient outcome. The pharmaceutical industry has over last few years largely neglected investing in the development of drugs for many CNS disorders. With reduced R&D spending and a need to boost productivity in finding new products, pharma increasingly relies on new concepts from partners like SHINKEI who are on the front lines of identifying unmet clinical needs. • SHINKEI was co-founded by Suresh Borsadia and GP Singh, industry veterans, having the mix of commercial and scientific backgrounds. They are supported by a small but efficient team of professionals, advisors and consultants. The co-founders began their idea generation and development in 2017 with rigorous literature search, KOL discussions and enlisting the right R&D partners Time Tuesday, Oct 22 11:15AM - 11:30AM Speakers GP Singh SHINKEI Therapeutics
11:30am Aspect Biosystems Tamer Mohamed, Aspect Biosystems show more Session Description Aspect Biosystems is a privately held biotechnology company pioneering microfluidic 3D bioprinting of living, human tissue. The company’s proprietary technology is enabling advances in understanding fundamental biology, disease research, development of novel therapeutics, and regenerative medicine. In addition to its internal programs, Aspect is focused on strategically partnering with pharmaceutical and biotechnology companies, as well as academic researchers, to enable the creation of living, human tissues for medical research, therapeutic discovery, and regenerative medicine products. Time Tuesday, Oct 22 11:30AM - 11:45AM Speakers Tamer Mohamed Aspect Biosystems Attentive Therapeutics Michael Reilly, Attentive Therapeutics show more Session Description Attentive Therapeutics is developing ATT-377 which combines a proven ADHD medication with an appetite protectant. ADHD is the most prevalent psychiatric disorder in children and until now, there has been no way to address the common appetite and weight suppression which limit current treatment with otherwise effective stimulants. We have recently successfully completed a prospective, double-blinded, placebo-controlled, dose-ranging clinical trial for ATT-377 which demonstrated a highly significant impact on weight while maintaining the high efficacy of stimulants on ADHD. Attentive Therapeutics has two patent families covering methods of use/treatment and composition of a single capsule. IP has issued and is pending. The company is looking to fund further development through licensing or additional funding. Time Tuesday, Oct 22 11:30AM - 11:45AM Speakers Michael Reilly Attentive Therapeutics InvivoSciences Inc. Ayla Annac, InvivoSciences Inc. show more Session Description InvivoSciences, Inc. (IVS) is a precision medicine company personalizing the drug development process by introducing patient-derived and gene-edited human samples, including 3D engineered micro tissues. Our unique integration of cell & tissue handling automation, tissue phenotyping assays, computational biology (AI), and human organ/tissue data enables rapid identification of safety and efficacy profile of a given treatment for specific patient group cost-effectively before expensive clinical trials. IVS’s technology helps with matchmaking the best treatment for the patient group to expedite the early discovery and clinical trials as well as supporting post-product launch monitoring. To accurately predict efficacy and safety of new drug candidates by recapitulating the human physiology of cardiac, smooth, skeletal muscle, and connective tissues in vitro. Time Tuesday, Oct 22 11:30AM - 11:45AM Speakers Ayla Annac InvivoSciences Inc. Nammi Therapeutics, Inc. David Stover, Nammi Therapeutics, Inc. show more Session Description Nammi Therapeutics utilizes nanocarriers to deliver synergistic anti-tumor and immunomodulatory combinations to the tumor microenvironment. An immunogenic cell death inducing chemotherapy primes the cancer site for recruitment of cytotoxic T cells in solid tumors. The response is sustained and synergistically enhanced by co-delivery of an immune adjuvant. The combined effect represents a unique mechanism of action providing a robust, systemic anti-tumor immune response, which can eliminate primary and metastatic disease, with immune memory. To date Nammi has raised ~$8M and is in late preclinical development with its first product with an IND scheduled for December 2019. Nammi has an exclusive license to the IP portfolio protecting the concept and specific products. A seasoned drug development management team is working with the scientific founders to continue to innovate novel products while prioritizing the efficient development of the initial product. Time Tuesday, Oct 22 11:30AM - 11:45AM Speakers David Stover Nammi Therapeutics, Inc. True Bearing Diagnostics, Inc Tisha Jepson, True Bearing Diagnostics show more Session Description True Bearing Diagnostics has developed TruCAD, the world’s first highly accurate RNA based blood-test diagnostic tool designed for the early-detection of coronary artery disease (CAD). At a fraction of the cost of coronary catheterization or nuclear imaging, the Company believes TruCAD is positioned to transform the coronary diagnostics industry. True Bearing was founded in 2015 to extend and commercialize certain research breakthroughs developed by the St. Laurent Institute and George Washington University’s Center for Genomic Medicine. The Company´s mission is to introduce a collection of RNA-based blood tests that will drastically decrease the costs associated with the early-detection and treatment of multiple diseases. For example, in addition to TruCAD, True Bearing is developing bio-marker panels that it believes will revolutionize the diagnosis of biofilm, appendicitis, pneumonia, and other diseases. Time Tuesday, Oct 22 11:30AM - 11:45AM Speakers Tisha Jepson True Bearing Diagnostics
12:30pm BIO’s President and CEO Jim Greenwood presents a Washington, DC, Policy Update James C. Greenwood, Biotechnology Innovation Organization (BIO) show more Session Description James C. Greenwood is President and CEO of the Biotechnology Innovation Organization (BIO) in Washington, D.C. BIO represents 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 countries worldwide. BIO members are involved in the research and development of innovative healthcare, agricultural, and industrial & environmental biotechnology products. BIO also produces the annual BIO International Convention, the world's largest annual gathering of the biotechnology industry, as well as other major investor and business conferences across the world. Greenwood represented Pennsylvania's Eighth District in the U.S. House of Representatives from 1993 to 2005. Since 2005, his deep relationships on Capitol Hill and knowledge of politics and policy have substantially raised BIO’s profile and enhanced the organization’s advocacy work. During his time in Congress, he was a senior member of the Energy and Commerce Committee and widely viewed as a leader on health care and the environment. He crafted legislation to reform the Food and Drug Administration, and he led the fight in Congress to allow stem-cell research to be conducted by U.S. scientists to treat disease. From 2001 to 2004, Greenwood served as Chairman of the Energy and Commerce Committee Subcommittee on Oversight and Investigation with oversight authority over issues in the full Committee's jurisdiction. He led hard-hitting investigations into corporate governance at Enron, Global Crossing and WorldCom; terrorist threats to our nation's infrastructure; and waste and fraud in federal government agencies. Prior to his election to Congress, Greenwood served six years in the Pennsylvania General Assembly (1981-86) and six years in the Pennsylvania Senate (1987-1992). Greenwood graduated from Dickinson College in 1973 with a B.A. in Sociology. From 1977 until 1980, he worked as a caseworker with abused and neglected children at the Bucks County Children and Youth Social Service Agency. Mr. Greenwood is married with three children and resides in Upper Makefield, Pennsylvania. Time Tuesday, Oct 22 12:30PM - 12:45PM Speakers James C. Greenwood Biotechnology Innovation Organization (BIO)
12:45pm Plenary—Public Policy Outlook on Biotech Investment from China Cameron Arterton, Biotechnology Innovation Organization; Helen Chen, L.E.K. Consulting; Joshua Gruenspecht, Wilson Sonsini Goodrich & Rosati; James Huang, Kleiner Perkins Caufield & Byers China; Panacea Venture show more Session Description According to Pitchbook, Chinese venture capital investment in U.S. biotechs has declined more than 60% in the first half of 2019. The increased review of the Committee on Foreign Investment in the US (CFIUS) on transactions, national security concerns, and trade negotiations have created a new landscape for cross-border business. The session will explore how biotech companies can continue to raise capital, the proposed rulemaking from CFIUS in the coming months, and a pathway for companies to remain innovative while CEOs and investors navigate these changes. Moderator: Cameron Arterton, Vice President, Tax Policy, Biotechnology Innovation Organization Time Tuesday, Oct 22 12:45PM - 1:40PM Speakers Cameron Arterton Biotechnology Innovation Organization Helen Chen L.E.K. Consulting Joshua Gruenspecht Wilson Sonsini Goodrich & Rosati James Huang Kleiner Perkins Caufield & Byers China; Panacea Venture
2:00pm Bilix Myung Kim, Bilix show more Session Description Bilix is a newly founded biotech company that specializes in developing new drugs for intractable diseases in inflammation and cancer. Its main technology has been developed by Endowed Professor at KAIST (Korean Advanced Institute of Science and Technology) for the past 7 years from which 3 patent applications have been transferred to Bilix. Bilirubin has been known to be a strong anti-oxidant and an effective immune modulator. Although its clinical implications and efficacies have been known and proved by hundreds of publications, it has never been developed into a clinical trials due to its strong toxicity arising from hydrophobicity. Bilix has developed a platform technology to improve efficacy and yet remove toxicity. Its efficacy has been tested and published in 7 different disease animal models (myocardial ischemic reperfusion injury, inflammatory bowl disease, GvHD, Asthama, organ transplant, etc) for $50 B + market. We are at stage of manufacturing for pre-clinical studies. Time Tuesday, Oct 22 2:00PM - 2:15PM Speakers Myung Kim Bilix Cerevance, Inc. Brad Margus, Cerevance, Inc. show more Session Description Cerevance is a private pharmaceutical company focused on central nervous system diseases. The company’s strengths include its powerful NETSseq target discovery platform, a large collection of human brain tissue samples, a pipeline of novel discovery-stage and clinical-stage compounds and a team with a proven track record. Its scientists believe that they are well positioned to deliver life-changing therapeutics for patients who have brain-related disorders. Time Tuesday, Oct 22 2:00PM - 2:15PM Speakers Brad Margus Cerevance, Inc. FenoLogica Biosciences, Inc. Sean MacLeod, FenoLogica Biosciences, Inc. show more Session Description Unlocking Opportunities in the New Frontier of Synthetic Biology - FenoLogica enables microbial researchers and bioengineers to do what they haven't been able to before. Our powerful instrumentation and cloud-based software tools are specifically designed to unlock the vital link between genomics and the understanding of biologic traits and behaviors (phenotypes) in cell biology. Functional data from large, synthetically derived, gene-variant cell libraries – using dynamic multiplexed assays – lead to broader experimental inquiry, quicker discoveries, and more precise biologic signatures. This data is critical to advancing everything from genetic related diagnostics and pharmaceutical discovery, to the development of microbiome therapeutics, novel biofuels, agricultural products, food science applications and biomaterials. These techniques have promise in solving the cause and cure of disease, helping our planet’s sustainability, and advancing humankind. Time Tuesday, Oct 22 2:00PM - 2:15PM Speakers Sean MacLeod FenoLogica Biosciences, Inc. Fireside Chat: Lon Cardon, PhD, Chief Scientific Strategy Officer, BioMarin Simone Fishburn, BioCentury Inc.; Lon Cardon, BioMarin Pharmaceutical Inc. show more Session Description . Time Tuesday, Oct 22 2:00PM - 2:55PM Speakers Simone Fishburn BioCentury Inc. Lon Cardon BioMarin Pharmaceutical Inc. Molecular Theranostics, LLC Yajuan Li, Molecular Theranostics, LLC show more Session Description Molecular Theranostics, LLC (MT or the Company) was formed in January 2014 in the state of Ohio. The goal of the company is development and commercialization of innovative imaging agents for the accurate detection and characterization of aggressive tumors. Specifically, we have developed a targeted MRI contrast agent (MT218) and a PET probe (MTP219) specific to an oncoprotein in tumor microenvironment. The efficacy of the imaging agents has been demonstrated in different tumor models, including breast cancer, liver cancer, pancreatic cancer, and prostate cancer. The imaging agents are effective to provide early detection of small aggressive solid tumors and able to differentiate aggressive tumors from benign tumors and tissues. The pre-clinical GLP safety data showed the safety of MT218. Clinical application of these imaging agents has great promise to provide much needed assistance to the physicians for precision cancer management Time Tuesday, Oct 22 2:00PM - 2:15PM Speakers Yajuan Li Molecular Theranostics, LLC Terran Biosciences Dustin Tetzl, Terran Biosciences show more Session Description Terran is a clinical stage biotech company developing therapeutics and diagnostics to change the lives of patients with neurological and psychiatric diseases. We have a phase 3 ready asset, multiple preclinical assets, and two complementary technologies that enable smart trials, increasing our probability of clinical and regulatory success: 1) Novel imaging device to measure clinically validated biomarkers 2) Best-in-class cerebral organoid precision medicine platform Both technologies will also be independently commercialized to generate near-term revenue and de-risk future development, with initial product launch planned for 2020 in a multi-billion dollar accessible market. We have an all-star leadership team on board with over 20 successful FDA approvals (including Abilify and Serzone), an experienced commercial launch team, and blue-chip early investors, including Peter Thiel, Christian Angermayer, and Presight Capital. Time Tuesday, Oct 22 2:00PM - 2:15PM Speakers Dustin Tetzl Terran Biosciences
2:15pm Avails Medical, Inc. Oren Knopfmacher, Avails Medical, Inc. show more Session Description Avails Medical, Inc. is an in vitro diagnostics company dedicated to providing solutions for the global challenge of antibiotic resistance and health-care associated infections. Avails is developing intuitive, streamlined, standalone applications, all based on its proprietary electrical biosensor platform. Applications will include electrical pathogen quantification, antibiotic susceptibility testing (AST) and identification of certain forms of resistance expressed in bacteria and fungi directly from a positive blood culture. Avails platform will advance the in-vitro diagnostics market by enabling timely diagnostics-guided therapy, meaningfully reducing the time to most effective and targeted treatment. For the majority of infectious disease diagnoses, Avails is expected to reduce treatment decisions from days to several hours. Avails first product is expected to start clinical trials in early 2020. Time Tuesday, Oct 22 2:15PM - 2:30PM Speakers Oren Knopfmacher Avails Medical, Inc. BCell Solutions, Inc. Bernard (Chip) Landman, BCell Solutions, Inc. show more Session Description BCell Solutions is commercializing its pipeline of patented and patent pending immunotherapies to treat various forms of chronic inflammatory diseases, including autoimmune and neurodegenerative diseases, and some cancers. R&D has reached an advanced pre-clinical stage, having now completed multiple rounds of drug synthesis, successful toxicity testing using mice, dog and human stem cells, and multiple rounds of in vivo and in vitro animal testing and human in vitro cell testing to validate use of our immunotherapies for the treatment of various diseases, many of which currently have no highly successful therapeutic treatment strategy. R&D to date has been supported by founder investments and non-dilutive grant funding. We are opening a seed funding round to support additional R&D activities, including Phase 0 trials, and also seeking collaboration and out-licensing opportunities with pharmaceutical partners to support completion of pre-clinical work and transition to clinical trials. Time Tuesday, Oct 22 2:15PM - 2:30PM Speakers Bernard (Chip) Landman BCell Solutions, Inc. Greenwich LifeSciences Snehal Patel, Greenwich LifeSciences show more Session Description Greenwich LifeSciences (GLS) is a private biopharmaceutical company located in Houston, TX that is developing GP2, a novel peptide immunotherapy that reduces the recurrence rates of breast cancer following surgery (adjuvant setting). Upcoming Phase III Clinical Trial – GLS is planning to launch a Phase III clinical trial in 2019, using a similar treatment regime as the Phase IIb trial. Compelling Clinical Phase IIb Data – In a randomized single-blinded multi-centered (15 sites) Phase IIb clinical trial of 180 HLA-A02 patients of which 101 patients are Her2/neu (3+) over expressor patients, GP2 displayed outstanding efficacy. After a minimum of 4 years of follow up, there were 0% cancer recurrences in the 51 Her2/neu (3+) patients treated with GP2-GMCSF-Herceptin, when fully vaccinated with the 6 primary injection series, versus a 12% cancer recurrence rate in the 50 patient placebo arm treated with GMCSF-Herceptin (p < 0.05). The fifth year of follow up will be concluded in 2018. Time Tuesday, Oct 22 2:15PM - 2:30PM Speakers Snehal Patel Greenwich LifeSciences Lupa Bio, Inc. Alexander Martinez, Lupa Bio, Inc. show more Session Description Lupa Bio is rapidly advancing a Phase-1 ready orally-delivered compound. Our therapeutic approach has broad potential of anti-inflammatory applications, but we’ve put together a streamlined development plan with our sights set first on oligoarticular juvenile idiopathic arthritis (orphan designation, pediatric voucher eligible)… and believe that the safety profile of our compound will justify going into this group, where there are currently no approved disease-modifying therapies. We have a compelling pre-clinical data package, a full non-clinical tox package, and our compound has already been tested in 3 human studies for an unrelated disease, with safety demonstrated and no adverse events at 20 grams per day, the highest dose tested. We are now preparing for our pre-IND meeting, which is planned for December this year, and are actively discussing with teams interested in an investment opportunity to advance the program/platform. Time Tuesday, Oct 22 2:15PM - 2:30PM Speakers Alexander Martinez Lupa Bio, Inc. Phosplatin Therapeutics Robert Fallon, Phosplatin Therapeutics show more Session Description The Company is engaged in the clinical development of its novel small molecule, PT-112, a first-in-class pyrophosphate conjugate with a pleiotropic mechanism of action (MOA) that promotes immunogenic cell death (ICD) without evidence of DNA damage. The Company is currently engaged in three Phase Ib/IIa clinical trials crossing solid tumors and hematological malignancies, having completed its requisite EOP1 meeting with the FDA. In addition, the Company is engaged in a Clinical Trial Collaboration with Pfizer and Merck KGaA (EMD Serono) investigating the combination of PT-112 with avelumab, a PD-L1 checkpoint inhibitor. The Company was awarded best poster amongst 50+ candidates in the Developmental Therapeutics category at ESMO 2018. In addition, PT-112's potent induction of immunogenic cell death was the subject of a poster presentation at the 4th Quad International Immunotherapy Conference 2018. PT-112 was also featured in posters presented at ASCO and ASH in 2017. Time Tuesday, Oct 22 2:15PM - 2:30PM Speakers Robert Fallon Phosplatin Therapeutics
2:30pm AIMM Therapeutics John Womelsdorf, AIMM Therapeutics show more Session Description AIMM is an antibody company which selects functional antibodies directly from cured cancer patients. We are advancing a lead compound into the clinic (Q4 2020) with the next clinical candidate to be designated in 2020. Time Tuesday, Oct 22 2:30PM - 2:45PM Speakers John Womelsdorf AIMM Therapeutics Haystack Sciences Jonathan Burbaum, Haystack Sciences show more Session Description Exponential reductions in the cost of DNA sequencing, combined with the advanced computational methods of machine learning & artificial intelligence (ML/AI), will inevitably disrupt the costly & time-consuming process of finding cures for difficult-to-treat diseases.Haystack is at the forefront. Haystack’s proprietary methods for synthesizing, breeding, and analyzing large, diverse combinatorial chemical libraries encoded by unique DNA sequences (DNA-Encoded Libraries, or DELs) establishes a revolutionary, data-intensive platform for discovering new cures for difficult-to-treat disorders. Most notably, Haystack has developed nDexer(tm), a platform for precise selections from DELs, and has applied it to a number of different targets and target classes, allowing the company to produce very large, high-quality data sets for subsequent computational analysis. Time Tuesday, Oct 22 2:30PM - 2:45PM Speakers Jonathan Burbaum Haystack Sciences Kleo Pharmaceuticals Doug Manion, Kleo Pharmaceuticals show more Session Description Kleo Pharmaceuticals is a unique immuno-oncology company developing next-generation bispecific compounds designed to emulate or enhance the activity of biologics. Similar to complex biologic drugs, Kleo’s compounds recruit the immune system to destroy cancer cells, but unlike biologics, Kleo’s compounds are smaller and more versatile, leading to potentially improved safety and efficacy. They are also much faster and less costly to design and produce, particularly against novel targets. The company is advancing several drug candidates based on its proprietary technology platforms, all of which are modular in design and enable rapid generation of novel immunotherapies that can be optimized against certain cancers, or enhance the properties of existing immunotherapies. These include Antibody Recruiting Molecules (ARMs), Synthetic Antibody Mimics (SyAMs) and Monoclonal Antibody Therapy Enhancers (MATEs). For more information visit Time Tuesday, Oct 22 2:30PM - 2:45PM Speakers Doug Manion Kleo Pharmaceuticals SynDevRx, Inc. James Shanahan, SynDevRx, Inc. show more Session Description SynDevRx is a clinical-stage biotech company developing drug candidates to treat cancers driven by metabolic hormones. Our first application is in combination with the PI3Ka inhibitor alpelisib in breast cancer, where we solve a major issue (hyperglycemia) and have demonstrated synergy with the drug class on efficacy. Time Tuesday, Oct 22 2:30PM - 2:45PM Speakers James Shanahan SynDevRx, Inc. X-Therma Xiaoxi Wei, X-Therma show more Session Description 800,000 deaths per year could be preventable by organ transplants, but fewer than 37,000 transplants are done early. Shockingly, 80% of transplantable organs are wasted. The main reason: we can preserve organs for a few hours only, which is hardly enough time to get from donor to patient without functional deterioration. X-Therma has developed a biomimetic cryoprotectant material that enables long term sub-zero storage of organs while preserving viability and functionality for transplant. Our goal is to enable greatly extended preservation times, going from hours to - months. According to the US Department of Defense, we may be able to abolish some waiting lists in as little as a couple of years. Better preservation enabled by X-Therma will not only result in many more organs available for transplant and thus lives saved, but also "better organs". Halting ischemic damage results in enhanced graft viability and faster recovery, and thus drastically shorter hospital stays. Time Tuesday, Oct 22 2:30PM - 2:45PM Speakers Xiaoxi Wei X-Therma
2:45pm Accuitis, Inc. Rick Coulon, Accuitis, Inc. show more Session Description Accuitis, Inc. is a US registered company with located in Peachtree Corners, GA. We are engaged in the development and formulation of dermatological & ophthalmic pharmaceuticals targeting niche, orphan, and under served indications. ADU-D1: Our lead discovery compound inhibits the transcription factor, nuclear factor kappa beta (NFkB), which is a potent mediator of inflammation. NFkB has already been shown to be a major, if not the major mediator of skin & ocular diseases including Rosacea. ACU-D1 have completed a Phase sucessful 2A clinical study in healthy patients with rosacea (sub-type 2) & anticipate advancing into phase 2B dose ranging studies in 2019. Honokiol Hexafluoro (ACU-D2); is a preclinical platform technology also discovered at Emory University. We have discovered that this compound is a Sirt 3 agonist and has potential in several unmet/under met clinical needs such as Systemic Scleroderma (SSc), Psoriasis, Retinopathy of Prematurity, and Diabetic Retinopathy Time Tuesday, Oct 22 2:45PM - 3:00PM Speakers Rick Coulon Accuitis, Inc. Daré Bioscience Sabrina Johnson, Daré Bioscience, Inc. show more Session Description Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women’s sexual health, vaginal health, fertility, and contraception. The company’s mission is to identify, develop and bring to market a portfolio of novel, differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women in the areas of contraception, vaginal health, sexual health, and fertility. Daré’s product portfolio includes potential first-in-class candidates in clinical development: Ovaprene®, a non-hormonal, monthly contraceptive vaginal ring; and Sildenafil Cream, 3.6%, a potential treatment for female sexual arousal disorder utilizing the active ingredient in Viagra®, as well as a proprietary solution-to-gel formulation of clindamycin to treat bacterial vaginosis via a single application, DARE-BV1. Time Tuesday, Oct 22 2:45PM - 3:00PM Speakers Sabrina Johnson Daré Bioscience, Inc. Info Session One-on-One Partnering at JPM Willie Reaves, Biotechnology Innovation Organization (BIO) show more Session Description The BIO One-on-One Partnering system is available for FREE to use during the 2019 J.P. Morgan Healthcare Conference (JPM) week to make it easier and more affordable to partner in downtown San Francisco from January 6-10, 2019. BIO is also offering affordable meeting space and creating the most comprehensive JPM Week event & reception guide to help you maximize your experience. Learn about these industry services and see a demo of the system. Info session attendees receive expedited access into the partnering system for JPM Week. Time Tuesday, Oct 22 2:45PM - 3:00PM Speakers Willie Reaves Biotechnology Innovation Organization (BIO) Satellos Bioscience Inc. Frank Gleeson, Satellos Bioscience Inc. show more Session Description Satellos is pioneering an original approach in regenerative medicine. We are developing small molecule drugs to stimulate innate tissue repair. Applicable to many tissue types, our initial application is muscle repair. Satellos is based on the discovery in our founder's labs of a key regulatory mechanism influencing the stem cell fate decision governs mitotic stem cell division which enables asymmetry. This process, called polarity, enables a stem cell to create one daughter cell which is a tissue precursor and one stem cell which sustains the pool. We have demonstrated the ability to influence this process with drug to stimulate intrinsic muscle repair in a mouse model of Duchenne muscular dystrophy. Our approach has potential in numerous muscle wasting and neuro-degenerative diseases. We are seeking Series A funding of $25M to complete our drug discovery efforts, undertake preclinical studies and fund Phase I/II clinical studies. Time Tuesday, Oct 22 2:45PM - 3:00PM Speakers Frank Gleeson Satellos Bioscience Inc.
3:00pm Actinium Pharmaceuticals, Inc. Sandesh Seth, Actinium Pharmaceuticals, Inc. show more Session Description Actinium Pharmaceuticals Inc. is focused on improving patient access and outcomes to cellular therapies such as bone marrow transplant (BMT) and CAR-T with its proprietary, chemotherapy free or sparing, targeted conditioning technology. Actinium is the only company with a multi-disease, multi-target, drug development pipeline focused on targeted conditioning. Its targeted conditioning technology is enabled by ARC’s or Antibody Radiation Conjugates that combine the targeting ability of monoclonal antibodies with the cell killing ability of radioisotopes. Actinium’s pipeline of clinical-stage targeted conditioning ARCs target the antigens CD45 and CD33 for patients with a broad range of hematologic malignancies including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM), acute lymphoblastic leukemia (ALL), Hodgkin’s lymphoma and Non-Hodgkin’s lymphoma. Time Tuesday, Oct 22 3:00PM - 3:15PM Speakers Sandesh Seth Actinium Pharmaceuticals, Inc. CerSci Therapeutics Lucas Rodriguez, CerSci Therapeutics show more Session Description With a focus on alleviating human suffering and rescuing society from the ongoing opioid crisis, CerSci Therapeutics is poised to deliver a new generation of non-opioid medicines to treat acute postoperative and chronic neuropathic pain (painful diabetic neuropathy). CerSci Therapeutics announced in February that their Investigational New Drug (IND) application for CT-044 has received notification from the United States Food and Drug Administration (FDA) indicating that its Phase I safety and tolerability clinical trial may proceed. CT-044, a non-metal based, orally bioavailable, small molecule Radical Species Decomposition Accelerant (RSDAx) of peroxynitrite and hydrogen peroxide, is proposed for the treatment of acute and chronic pain, including acute post-surgical pain and painful diabetic neuropathy. CerSci's phase I study will commence clinical conduct in June with subject dosing commencing in July 2019. Time Tuesday, Oct 22 3:00PM - 3:15PM Speakers Lucas Rodriguez CerSci Therapeutics Ethris GmbH Gita Dittmar, Ethris GmbH show more Session Description Ethris is a privately-held German biotechnology company developing messenger RNA therapeutics for pulmonary disorders. Our pipeline is based on Ethris' proprietary SNIM(R)RNA platform, which incorporates multiple mRNA design elements to produce highly active and non-immunogenic mRNA payloads into nanoparticles, for delivery by nebulization to address disorders of the respiratory tract. Ethris' pipeline is focused on orphan genetic pulmonary diseases, and we collaborate with AstraZeneca in the areas of asthma, COPD, and idiopathic pulmonary fibrosis. Ethris' lead program, ETH42, is in preclinical development for primary ciliary dyskinesia, with a first in man study planned for initiation in 2020. Time Tuesday, Oct 22 3:00PM - 3:15PM Speakers Gita Dittmar Ethris GmbH Incysus Therapeutics, Inc. William Ho, Incysus Therapeutics, Inc. show more Session Description Incysus is focused on delivering a novel off-the-shelf cell therapy for the treatment of cancer. By using genetically modified gamma-delta (γδ) T cells, the Company’s technology addresses the challenges that immunotherapies face targeting cold, low mutation cancers. The company has received FDA approval for two INDs and expects to initiate two Phase I programs in 2019. Time Tuesday, Oct 22 3:00PM - 3:15PM Speakers William Ho Incysus Therapeutics, Inc. Recruiting Talent to Meet Corporate Board Requirements and Representation Goals Cissy Young, Russell Reynolds Associates; Matthew Fust, Independent Advisor to Life Sciences Companies; KT Moortgat, AbbVie Ventures; William J. Newell, Sutro Biopharma; Amanda K. Packel, Rock Center for Corporate Governance at Stanford University show more Session Description By the end of 2019, publicly traded companies in California must have at least one woman director and those targets will increase by 2021. Massachusetts, Pennsylvania, and New Jersey along with other states have considered similar targets which will impact the biotechnology industry. As start-ups and small and medium sized biotech companies consider company growth and future exits, starting early with inclusive hiring practices and board recruitment has become a business priority. Attend this session to gain insight on corporate governance best practices and tips on conducting searches for companies to remain innovative and competitive in this changing environment. Resources for leadership teams and boards will be shared including tools created as part of BIO’s recently launched "Right Mix Matters" campaign. Moderator: Cissy Young, Managing Director, Russell Reynolds Associates Time Tuesday, Oct 22 3:00PM - 3:55PM Speakers Cissy Young Russell Reynolds Associates Matthew Fust Independent Advisor to Life Sciences Companies KT Moortgat AbbVie Ventures William J. Newell Sutro Biopharma Amanda K. Packel Rock Center for Corporate Governance at Stanford University Tempo Therapeutics Westbrook Weaver, Tempo Therapeutics, Inc show more Session Description Tempo is a therapeutic device company pioneering a new era in tissue regeneration, using fully-synthetic and injectable scaffolding materials that unlock the body’s own regenerative capacity by controlling tissue inflammation. Enabled by our proprietary MAP technology, our products are powered by unique physical micro-geometries - creating immune-stealth scaffolds that promote rapid, regenerative healing without the need to deliver cells or biologics. Tempo is a platform technology company led by a team of innovators, entrepreneurs, and experienced biotechnology executives. We are creating a suite of precision-engineered, mass-manufacturable clinical tools to transform therapy in tissues including skin, soft tissue, orthopedic, neural and cardiac applications. True tissue engineering has long been the unifying goal in a rapidly growing $22B market, for which Tempo holds the enabling technology. Our mission is to set the pace in the next generation of tissue therapeutics. Time Tuesday, Oct 22 3:00PM - 3:15PM Speakers Westbrook Weaver Tempo Therapeutics, Inc
3:15pm BioMarker Strategies, LLC Jerry Parrott, BioMarker Strategies, LLC show more Session Description BioMarker Strategies is a privately held molecular diagnostics company founded in 2006 at The Johns Hopkins Science & Technology Park in Baltimore, and now based in Rockville, Maryland. Our mission is to help make personalized medicine more of a reality for patients with solid tumor cancers, by providing powerful new molecular tools and research services to guide targeted drug development and treatment selection for these patients. Time Tuesday, Oct 22 3:15PM - 3:30PM Speakers Jerry Parrott BioMarker Strategies, LLC Ensysce Biosciences, Inc. Lynn Kirkpatrick, Ensysce Biosciences Inc show more Session Description Ensysce is a clinical stage biopharma company with a novel prodrug technology that, when applied to prescription medications, prevents abuse and overdose. Our lead program PF614 uses this technology to make pain medication safer for patients and physicians. Approximately 30 people per day in the USA are dying by overdosing on opioids and endless more are abusing by chewing, injecting or snorting. They do this to immediately concentrate the ‘euphoria’ in the first minutes of taking the drug instead of the intended slower release. Our technology cannot be ‘cracked’ outside of the body because it only releases the active ingredient (oxycodone) after it mixes inside the gut with an enzyme (Trypsin), forcing a true 12-hour release. This is novel compared to the reformulated ADFs currently on the market. Our Second technology (MPAR) for overdose prevention controls how much active ingredient will be released into the system at any one time if more than prescribed are ingested. Time Tuesday, Oct 22 3:15PM - 3:30PM Speakers Lynn Kirkpatrick Ensysce Biosciences Inc Heartseed Inc. Kikuo Yasui, Heartseed Inc. show more Session Description Heartseed was founded in 2015 by Prof. Keiichi Fukuda, MD, PhD at Keio Univ. School of Medicine, to put his 20-year research results of cardiac regenerative medicine into practice. Current total # of employees is 27. Our lead pipeline, HS-001 is iPSC-derived highly purified ventricular specific cardiomyocytes. MoA is remuscularization and MoA is intramyocardial injection using a special device. Strengths includes: 1) First-in-class advanced stage, 2) High and certain efficacy by remuscularization, 3) Low risk of arrhythmia due to high purification using metabolic selection, 4) Large scale auto-manufacturing system under development 5) Robust IP protection including purification methods, injection device, large-scale cell culture etc. We are planning to initiate FIH for three DCM patients led by Keio Univ. in late 2019. Ph1/2 trial for patients with HFrEF in Japan is planned to be initiated in late 2020, followed by NDA using fast-track approval system in Japan. Time Tuesday, Oct 22 3:15PM - 3:30PM Speakers Kikuo Yasui Heartseed Inc. NB Health Laboratory Co., Ltd Kiyoshi Takayama, NB Health Laboratory show more Session Description Since 2008, NBHL has focused on establishing a technology platform for the generation of functional mAbs targeting GPCRs to pioneer a new field in GPCR-targeted drug discovery, in collaboration with universities and other partners in Japan. The result is a proprietary technology platform, which is now attracting interest for its potential to be used for the generation of therapeutic antibodies. NBHL has used the technology platform to discover promising mAbs targeting GPCRs for the treatment of respiratory diseases ,chronic inflammation, infection, ocular and immune-oncology which are being progressed towards clinical development. NBHL’s core business model is to provide the pharmaceutical industry with innovative drug candidates, including mAbs targeting GPCRs and small molecules. Through collaborations with pharmaceutical companies, NBHL operates its proprietary technology platform to run drug discovery programs according to specifications provided by its customers. Time Tuesday, Oct 22 3:15PM - 3:30PM Speakers Kiyoshi Takayama NB Health Laboratory Pacylex Pharmaceuticals, Inc. Michael Weickert, Pacylex Pharmaceuticals, Inc. show more Session Description Pacylex is a Canadian oncology company exploiting a new discovery in cancer biology which may explain how some cancers arise from normal cells. The company is responding to this discovery by developing a first-in-class, oral drug, PCLX-001, to turn on selective lethality, apoptosis, in these cancer cells, while leaving normal cells unharmed. Animal tests show this drug candidate completely eliminates tumors in xenograft models of leukemias and lymphomas. PCLX-001 also kills many solid tumor cancer cell lines and retards tumor growth in some PDX models of human lung and breast cancer. Pacylex is part of the new Merck-sponsored Accelerator in Edmonton. A Note investment round is funding studies necessary to file an IND in early 2020 for PCLX-001. Our potent activity against malignant lymphocytes and in acute leukemia coupled with the absence of bone marrow and lymphocyte toxicity in 14-day tox studies in 2 species suggest a therapeutic index consistent with a solid clinical candidate. Time Tuesday, Oct 22 3:15PM - 3:30PM Speakers Michael Weickert Pacylex Pharmaceuticals, Inc.
3:30pm Bird Rock Bio. Inc. Paul Grayson, Bird Rock Bio Inc. show more Session Description Bird Rock Bio is a clinical stage biopharmaceutical company focused on developing innovative immuno-inflammatory regulators. Backed by leading biotechnology venture investors, our strategy leverages biologic targets with substantial human proof of mechanism for the development of novel, best-in-class therapeutic antibodies with significant clinical and commercial differentiation. Time Tuesday, Oct 22 3:30PM - 3:45PM Speakers Paul Grayson Bird Rock Bio Inc. Histogen Inc. Richard Pascoe, Histogen Inc. show more Session Description Histogen is a regenerative medicine company focused on developing patented, innovative technologies for aesthetic and therapeutic markets based on stimulating the body’s stem cells to regenerate tissues and restore youthful function. The Company’s lead therapeutic product has demonstrated in clinical studies to stimulate hair growth, addressing an underserved, multibillion dollar global market. Further applications of the technology include skincare, orthopedics indications such as cartilage formation and spinal disk repair, wound healing and dermal fillers. Time Tuesday, Oct 22 3:30PM - 3:45PM Speakers Richard Pascoe Histogen Inc. Neumentum, Inc. Scott Shively, Neumentum, Inc. show more Session Description Neumentum, Inc. is a privately held pain and neurology specialty pharmaceutical company that is developing novel, non-opioid pain therapeutics. Time Tuesday, Oct 22 3:30PM - 3:45PM Speakers Scott Shively Neumentum, Inc. Savanamed Ignacio H. Medrano, Savanamed show more Session Description Savana is an international medical company with the vision to accelerate health science by giving healthcare providers the power to reuse their information safely and without losing control. Founded in 2014, Savana develops and applies Artificial Intelligence techniques, such as NLP, Machine Learning, and Deep Learning with the aim to provide with a large-scale, comprehensive and robust system designed to automatically process and structure information from EHR’s free-text clinical records to support clinical research and practice. Savana is number one in the amount of EHRs read. Its EHRead technology has already read more than 400M clinical documents, it is already implemented in over 80 hospitals and over 18 RWE studies across all pathological areas are being run. Now available for reading English, French, German and Spanish EHRs and operating in North America and Europe. Time Tuesday, Oct 22 3:30PM - 3:45PM Speakers Ignacio H. Medrano Savanamed TheraTarget C. Matthew Peterson, TheraTarget show more Session Description TheraTarget holds the patent and licensing rights for a widely applicable polymer-anti-cancer agent delivery platform technology that dramatically improves the efficacy of traditional and novel anticancer agents by specifically targeting solid tumors, reducing adverse systemic effects, maximizing drug efficacy as well as creating an immunogeneic tumor microenvironment. Our therapeutic targets are breast, non small cell lung cancer, pancreatic and ovarian cancers which total nearly 600,000 cases and over 250,000 deaths per year, respectively. These markets currently total $34B annually ($18B breast, $14B nsclc, $1.6B pancreatic and $1.4 B ovarian). Animal toxicology, IND submission and new patents for HPMA-epirubicin are our 2020 goals to achieve a PHARMA exit. Patent and licensing protection for the basic platform continues until 2031 with the opportunity for serial new patents available for combinations of new and off patent polymer-chemotherapeutic/-immunomodulating agents. Time Tuesday, Oct 22 3:30PM - 3:45PM Speakers C. Matthew Peterson TheraTarget
3:45pm Antev Ltd Finn Larsen, Antev Ltd show more Session Description We are a UK-based injectable GnRH company that is looking to go to Phase 3 trials in prostate cancer and benign prostatic hyperplasia in the next 18 months. We have dosed over 850 times with no drug-related SAEs and we have excellent site reaction from our injections in contrast to our only injectable competitor, Degerelix. Recent pilot trial data has highlighted the CV risk associated with agonists is potentially four times higher than with antagonists when treating high risk CV patients. Time Tuesday, Oct 22 3:45PM - 4:00PM Speakers Finn Larsen Antev Ltd Nanostics Inc John Lewis, Nanostics Inc show more Session Description Nanostics is a privately held Alberta-based company focused on the development and commercialization of novel, non-invasive diagnostic tests for cancer and other diseases. The technology at the core of Nanostics is an advanced liquid biopsy platform and state of the art machine learning algorithm for accurate diagnoses from a single drop of blood. The technology is applicable to a wide range of diseases including prostate, ovarian, pancreatic cancers, as well as cardiovascular, degenerative and neurological diseases. Nanostics’ lead product, ClarityDX Prostate, is the most accurate diagnostic test to diagnose aggressive prostate cancer, and is positioned to emerge as the world’s leading diagnostic tool for prostate cancer. Time Tuesday, Oct 22 3:45PM - 4:00PM Speakers John Lewis Nanostics Inc NeuroBo Pharmaceuticals John L. Brooks, NeuroBo Pharmaceuticals show more Session Description NeuroBo Pharmaceuticals, jointly founded by JK BioPharma Solutions that specializes in the development of new biopharmaceuticals, and Dr. Roy Freeman, a Harvard Medical School neurologist, to develop naturally sourced neuroscience-focused medicines. NeuroBo’s lead candidate NB-01, licensed from pharma company, Dong-A ST, targets diabetic neuropathic pain and increases levels of the neurotrophin, nerve growth factor (NGF). NGF inhibits nerve cell death and promotes nerve regeneration. NB-01, derived from natural sources, has shown successful Phase II results with excellent efficacy and safety in diabetic neuropathic pain and is initiating a Phase III clinical trial in late 2019. NeuroBo has strong preclinical data in neuropathic pain and diabetes models showing a mode of action of NB-01 on NGF and in reducing inflammation and clearing advanced glycation end products. NeuroBo has a second compound focusing on Alzheimer's disease currently ready for an IND and a FIH trial. Time Tuesday, Oct 22 3:45PM - 4:00PM Speakers John L. Brooks NeuroBo Pharmaceuticals Orion Biotechnology Canada Ian McGowan, Orion Biotechnology show more Session Description Orion Biotechnology is a clinical stage Canadian Biotechnology company with operations in Switzerland and Poland. Orion’s primary research focus is the development of chemokine analogues for multiple indications. Chemokine receptors play a critical role in various immunological responses & chemokine analogues are small proteins that have the potential to be safer than small molecule drugs and more potent than mAbs. Orion has a proprietary chemokine analogue discovery platform that allows accelerated discovery & development of novel chemokine analogues across many therapeutic areas. Our lead candidate is OB-002, a best-in-class CCR5 antagonist based on potency. It has an excellent safety profile. Our lead indication is oncology where CCR5 is a validated target. We have robust evidence showing that OB-002 has anticancer efficacy in animal models. CCR5 is a novel target in MS and we have data that OB-002 is efficacious. We start Phase 1 study of OB-002 for HIV prevention in Q3 2019 Time Tuesday, Oct 22 3:45PM - 4:00PM Speakers Ian McGowan Orion Biotechnology SpinalCyte Pete OHeeron, SpinalCyte, LLC show more Session Description Based in Houston, Texas, SpinalCyte, LLC, is a regenerative medicine company developing an innovative solution for spinal disc regeneration using human dermal fibroblasts. Currently, SpinalCyte holds 39 U.S. and international issued patents and has filed for an additional 100+ patents across a variety of disease pathways, including disc degeneration, multiple sclerosis, cancer, diabetes, liver failure and heart failure. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit Time Tuesday, Oct 22 3:45PM - 4:00PM Speakers Pete OHeeron SpinalCyte, LLC
4:00pm Cesca Therapeutics Inc. Jeff Cauble, Cesca Therapeutics Inc. show more Session Description Cesca Therapeutics Inc. is a market leader in cell processing technologies and autologous cell therapies for regenerative medicine. Its device division, ThermoGenesis, develops, commercializes and markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology. The Company’s automated, functionally-closed CAR-TXpress™ platform is designed to streamline the manufacturing process for the emerging CAR-T immunotherapy market Time Tuesday, Oct 22 4:00PM - 4:15PM Speakers Jeff Cauble Cesca Therapeutics Inc. Innovate Biopharmaceuticals, Inc. Jay Madan, Innovate Biopharmaceuticals, Inc. show more Session Description Innovate is a publicly traded (Nasdaq: INNT) clinical stage biotechnology company focused on developing novel medicines for autoimmune and inflammatory diseases with unmet needs. Our pipeline includes drug candidates for celiac disease, NASH, Crohn's, and ulcerative colitis. Innovate is led by a strong management team with extensive drug development experience and a history of bringing novel therapeutics to market. All global rights to the products, which are backed by more than 150 patents worldwide, are owned by the company. Time Tuesday, Oct 22 4:00PM - 4:15PM Speakers Jay Madan Innovate Biopharmaceuticals, Inc. Intabio Lena Wu, Intabio show more Session Description Development and manufacture of biopharmaceuticals requires continual testing to ensure quality and consistency across process steps and from batch-to-batch. Current testing is cumbersome and low-throughput, failing to provide the real time analytics that today’s rapidly growing $200B biopharma industry desperately needs. Intabio is addressing the acute unmet need for rapid, automated product quality analysis with the Blaze System, a transformative solution based on a decade’s worth of deep insight into bioproduction needs. Instead of weeks and a lab full of equipment. Intabio’s Blaze System provides a comprehensive, one-stop analysis of biopharmaceutical product quality in minutes per sample, processing 100-fold more samples at a fraction of the cost. The Blaze System utilizes Intabio’s proprietary microchip platform to integrate gold-standard analytical approaches for separation, quantitation, and molecular identity. The total annual US market for the Blaze system is over $1B. Time Tuesday, Oct 22 4:00PM - 4:15PM Speakers Lena Wu Intabio OxSonics Therapeutics Colin Story, OxSonics Therapeutics show more Session Description Penetration of anti-cancer agents into and throughout solid tumours is widely recognised as presenting a major limitation to their effectiveness. OxSonics Therapeutics’ proprietary platform technology, SonoTran®, is being developed to enable a step-change in the therapeutic index of anti-cancer agents by increasing their dose and distribution within solid tumours without any development costs or delays associated with their reformulation. The approach has been specifically designed to fit seamlessly into existing oncology clinical workflows, and has the major advantage of enabling healthcare professionals to see-as-they-treat by providing visualisation on-screen and in real time. The SonoTran drug delivery platform is based on ground-breaking technological advances, originally invented at the University of Oxford’s Institute of Biomedical Engineering. Time Tuesday, Oct 22 4:00PM - 4:15PM Speakers Colin Story OxSonics Therapeutics SyntheX Maria Soloveychik, SyntheX show more Session Description SyntheX uses synthetic biology to create the next generation of drug discovery platforms for modulating protein-protein interactions (PPIs). Using genetically engineered cells, our platform technology relies on intracellular drug selection as opposed to in vitro screening. We have developed ToRPPIDO to discover disruptors of PPIs, and ToRNeDO to discover functional protein degraders using an E3 ligase and a neosubstrate of interest. The platforms can use our DNA encoded peptide and macrocycle libraries, or small molecule screening. Our lead program, STX100, targets an intracellular PPI within the homologous recombination (HR) DNA repair pathway. We have discovered and characterized a new cell death mechanism that exploits the differential abundance of the HR target in cancer cells relative to healthy tissue to elicit an acute calcium-dependent cell death upon binding of STX100 to its target. This program demonstrated in-vivo efficacy and a remarkable synergy with checkpoint inhibitors. Time Tuesday, Oct 22 4:00PM - 4:15PM Speakers Maria Soloveychik SyntheX View from the Board: To IPO Now or Not? Linda Grais, Ocera Therapeutics; Michael O'Donnell, Morrison & Foerster LLP; Saira Ramasastry, Life Sciences Advisory; Chris Lowe, Cortexyme; Christine Siu, Eidos Therapeutics show more Session Description With uncertain market conditions and concerns about realistic valuation expectations, innovative biotechs are trying to pinpoint the right time to go public. The right executive team and a clear, strategic roadmap have become more imperative as companies continually receive mixed signals from potential bookrunners and concerns are raised over IP in course of making a compelling case for going public and gaining access to capital markets. This panel will review how to structure those conversations and decisions around the current landscape and be as productive as possible toward timing the market accurately for a future IPO. Time Tuesday, Oct 22 4:00PM - 4:55PM Speakers Linda Grais Ocera Therapeutics Michael O'Donnell Morrison & Foerster LLP Saira Ramasastry Life Sciences Advisory Chris Lowe Cortexyme Christine Siu Eidos Therapeutics
Wednesday, October 23
8:30am Progress in CNS Drug Development Outside Dementia Tao Huang, NeuCyte;Cenova Capital; Robert Molinari, Retrotope; Alice Chen, Accelerator Life Science Partners; Adam Shaywitz, BridgeBio Pharma; Ellen Lubman, Impel NeuroPharma show more Session Description Recent studies from the National MS Society have estimated that nearly one million people in the United States are suffering from Multiple Sclerosis. Another thirty thousand suffer from ALS, and thousands more from other CNS disorders that remain without a cure. In order to address the unmet medical needs of this patient population, dozens of companies from across the biotechnology industry are involved in late-phase clinical trials that are exploring the efficacy of different drug treatments on a variety of CNS disorders. On the investment side of the equation, neurology companies had the third highest number of biopharma deals in the first half of 2019, with over $800 million invested, according to the Silicon Valley Bank Mid-Year Report 2019. Hear from researchers and biotech executives involved in CNS drug development to gain insight into how the industry is expanding and the current clinical trials that have the potential to provide life-changing therapeutic solutions. Time Wednesday, Oct 23 8:30AM - 9:40AM Speakers Tao Huang NeuCyte;Cenova Capital Robert Molinari Retrotope Alice Chen Accelerator Life Science Partners Adam Shaywitz BridgeBio Pharma Ellen Lubman Impel NeuroPharma
9:00am ADAM Denys Gurak, ADAM show more Session Description A.D.A.M./Advanced Development of Additive manufacturing/ targets artificial bones and tissues market with its 3D printing proprietary technology Business model can be defined as on-demand personalized tissue manufacturing with full scope of related services (software, equipment, certification, digital platform etc); remotely or on site (in hospital) ADAM proprietary technology includes 3D printing of different tissues, made of organic materials, which can be scalably and cheaply produced and used Time Wednesday, Oct 23 9:00AM - 9:15AM Speakers Denys Gurak ADAM Mantra Bio Alex Mok, Mantra Bio show more Session Description Mantra Bio is a therapeutics company harnessing exosomes for highly targeted in vivo delivery. Mantra is the creator of REVEAL, the world’s first exosome intelligence platform leveraging lab automation and AI to discover targeted exosome vehicles (TEVs) that can be directed towards specific cell and tissue targets to deliver a range of therapeutic payloads. Using REVEAL, novel targeted exosome vehicles (TEVs) are rapidly discovered using computational biology, engineered via bench automation, and validated in vivo. Mantra's has developed TEVs for highly targeted drug delivery to treat intractable cancers and other diseases. Time Wednesday, Oct 23 9:00AM - 9:15AM Speakers Alex Mok Mantra Bio Shifa Biomedical Corporation Sherin Abdel-Meguid, Shifa Biomedical Corporation show more Session Description Shifa is a privately held company dedicated to the development of drugs for the treatment of cardiovascular disease. Shifa has developed an oral, small molecule (P-21), that interferes with the function of PCSK9. P-21 significantly lowers LDL cholesterol; it is as potent as the injectable monoclonal antibody. Being oral, P-21 does not require injection or refrigeration necessary for biological agents like the PCSK9 antibodies Repatha or Praluent. The advantages of an oral small molecule versus an injectable antibody are significant; a small molecule: a) has significantly higher profit margins because of low manufacturing cost, b) can be formulated as a once daily fixed-dose combination with a statin, c) no anticipated immunogenicity, and d) no injection site complications. Furthermore, doctors, patients and payers always prefer oral to injectable. P-21 lowers LDL-cholesterol by about 90% in mice fed high-fat diet when mice are given 30 mg/kg daily doses of the compound for two weeks. Time Wednesday, Oct 23 9:00AM - 9:15AM Speakers Sherin Abdel-Meguid Shifa Biomedical Corporation SmartPharm Therapeutics Jose Trevejo, SmartPharm Therapeutics show more Session Description SmartPharm Therapeutics is a gene therapy company applying the next generation of non-viral DNA and RNA technologies to treat serious human diseases. Founded with the vision of producing “Biologics from Within,” SmartPharm is focused on bringing together unique technology and developmental capabilities for the treatment of rare diseases including lysosomal storage disorders. Time Wednesday, Oct 23 9:00AM - 9:15AM Speakers Jose Trevejo SmartPharm Therapeutics ThromboTherapeutics Inc. Michael Chapman, ThromboTherapeutics Inc. show more Session Description ThromboTherapeutics Inc. (TTI) is a medical therapeutics and diagnostics startup, founded in 2017 and based in Denver and Boston, working in partnership with the University of Colorado School of Medicine and the Massachusetts Institute of Technology. Our focus is on the treatment of bleeding and coagulation disorders, particular in the setting of traumatic injury, which results in 2.8 million hospitalizations and 214,000 deaths each year, in the U.S. alone. Our flagship product, the tPA-Challenge™ assay repurposes the “clot busting” agent tPA to rapidly test the physiologic reserve of the patient’s coagulation system and predicts their risk of massive hemorrhage, allowing triage decisions to be made an hour faster than with existing tests. The tPA-Challenge™ has been validated in over 900 trauma patients, is being sold commercially for research use, and is shovel-ready for a pivotal trial/FDA approval. Time Wednesday, Oct 23 9:00AM - 9:15AM Speakers Michael Chapman ThromboTherapeutics Inc.
9:15am ActoBio Therapeutics, Inc. Pieter Rottiers, ActoBio Therapeutics, Inc. show more Session Description ActoBio Therapeutics is an innovative, clinical stage biotechnology company pioneering a new class of microbe-based biopharmaceuticals, ActoBiotics®, that enable expression and local delivery of disease-modifying therapeutics. The ActoBiotics platform produces biologics through oral or local administration with treatment applications across many diseases. This approach is being developed to provide safer and more efficacious treatments than injectable biologicals. ActoBio Therapeutics has a strong R&D pipeline and several therapeutic programs in advanced developmental stages, including Phase 1b/2a and Phase 2b clinical trials. For further information and updates please visit us at Time Wednesday, Oct 23 9:15AM - 9:30AM Speakers Pieter Rottiers ActoBio Therapeutics, Inc. Jaan Biotherapeutics LLC Bhawanjit Brar, Jaan Biotherapeutics LLC show more Session Description Jaan Biotherapeutics LLC (JBT) is a biotechnology company developing a first-in-class regenerative therapy that modulates the activity of microRNAs to repair damaged heart muscle to treat Ischemic Heart Disease, the largest cause of death in the US. MicroRNAs (miRs) function in RNA silencing and post-transcriptional regulation of gene expression by modulating the activity of a number of genes and compensatory pathways. JBT has designed, developed and patented a single virus, known as JBT-miR2 that delivers inhibitors to four miRs; miR-100, miR-99, let-7a and let-7c to reprogram adult mono-nuclear de-differentiated cardiomyocytes within the murine ischemic heart to proliferate. JBT-miR2 has completed extensive preclinical safety and efficacy testing in mice models of the disease. The results of these studies show a 45% decrease in scar tissue, 30% decrease in cardiac volumes and 20% increase in heart function with no safety concerns. We are seeking funds to complete our IND studies. Time Wednesday, Oct 23 9:15AM - 9:30AM Speakers Bhawanjit Brar Jaan Biotherapeutics LLC NaNotics, LLC Lou Hawthorne, NaNotics, LLC show more Session Description NaNotics, LLC is a privately held company based in Mill Valley, CA, currently raising a Series B funding round. NaNotics is developing a new method of treating cancer: a novel class of injectable nanoparticles – called NaNots – that scavenge tumor-generated immune inhibitors from circulation, creating a “diffusion sink” that induces migration of inhibitors from the tumor microenvironment (TME) – enabling immune response and tumor regression. Cancers surround themselves with these molecules, which limit efficacy of cancer immunotherapies. NaNots hold promise as both mono- and adjunctive therapies. The company has both in vitro and in vivo (mouse) data on efficacy. NaNotics is also engineering a set of NaNots against specific inflammatory cytokines that drive both acute and chronic autoimmune and auto-inflammatory disorders. The NaNot platform is the subject of 3 granted patents and 7 pending patents. Time Wednesday, Oct 23 9:15AM - 9:30AM Speakers Lou Hawthorne NaNotics, LLC Phanes Therapeutics, Inc. Ming Wang, Phanes Therapeutics show more Session Description Phanes Therapeutics is an emerging leader in innovative discovery research in the immuno-oncology area and eye diseases. Founded in July 2016, Phanes has a leadership team of industry veterans with extensive drug discovery and development experience in the global pharma and biotech companies, including Pfizer, Amgen, and J&J. Our first-in-class molecules include a mAb for solid tumors as well as age-related macular degeneration (AMD), diabetic macular edema (DME) and diabetic retinopathy (DR), and a bispecific antibody for small cell lung cancer. Our pipeline also includes humanized single-chain variable fragments (scFv) against multiple tumor-specific antigens that are suitable for constructing CAR-Ts to target solid tumors. Our mission is to become a source of innovation in the biopharma industry and we are fully committed to delivering robust therapeutic molecules to patients. We will continue to leverage partnerships with companies that have capabilities complementary to ours. Time Wednesday, Oct 23 9:15AM - 9:30AM Speakers Ming Wang Phanes Therapeutics Senti Biosciences Gary Lee, Senti Bio show more Session Description Senti Biosciences is a Series A next-generation biotechnology company that designs gene circuits and programs cells for tremendous therapeutic value. Senti's mission is to engineer an entirely new class of medicine that will transform people’s lives by curing the most complex diseases. Backed by a syndicate of leading biotech and tech investors including NEA, 8VC, Lux, Pear, Menlo Ventures, and Amgen Ventures, and led by an experienced team with deep translational knowledge of advanced cell therapies, the company is leveraging its proprietary gene circuit repertoire to solve the most pressing unmet needs in oncology and other difficult disease areas. Time Wednesday, Oct 23 9:15AM - 9:30AM Speakers Gary Lee Senti Bio
9:30am Aristea Therapeutics James Mackay, Aristea Therapeutics show more Session Description Aristea Therapeutics (Air-iss-tay-uh) is a clinical-stage drug development company developing novel therapies to treat serious inflammatory diseases. The Aristea team is leveraging its broad industry expertise and proven success in drug development to form synergistic partnerships and build a pipeline of novel drugs. Aristea’s lead program, RIST4721, is currently in Phase 2 clinical development for Palmoplantar Pustulosis (PPP), a rare neutrophil driven inflammatory skin disease for which there are no approved therapies in the the US or EU. Time Wednesday, Oct 23 9:30AM - 9:45AM Speakers James Mackay Aristea Therapeutics Elex Biotech, Inc. Douglas Kawahara, Elex Biotech, Inc. show more Session Description Elex Biotech Inc is a drug discovery and development company focused on first-in-class NCEs for the treatment of arrhythmia and heart failure. Using rational drug design and an internally generated SAR database, the Company has generated ~200 NCEs that stabilize mutant or dysfunctional RyR2, the Ca2+ release channel that regulates heart muscle contractions. Certain arrhythmias and heart failure share a common defect in Ca2+ handling resulting from RyR2 dysfunction that is addressed by Elex Biotech’s compounds. Elex Biotech has a lead and backup compounds with in vivo proof of concept in animal models of catecholaminergic polymorphic ventricular tachycardia (CPVT), an orphan disease estimated to cause 15% of unexplained sudden cardiac death in apparently healthy young people. Elex Biotech has been funded to date by ~$2M in NHLBI STTR grants and, in June 2019, received an NHLBI Phase IIB Small Market Award of ~$3M to advance its lead candidate through IND-enabling studies. Time Wednesday, Oct 23 9:30AM - 9:45AM Speakers Douglas Kawahara Elex Biotech, Inc. Lempo Therapeutics Oren Glanz, Lempo Therapeutics Ltd. show more Session Description Lempo Therapeutics is a pre-clinical stage startup company developing a novel treatment for Pulmonary Arterial Hypertension, a fatal orphan disease, and a major unmet clinical need. Lempo patented treatment is based on stem cell gene editing and is also applicable to major neurodegenerative diseases (AD, PD, MS). The co-founders' personal story leading to founding Lempo deserves an independent presentation :) Time Wednesday, Oct 23 9:30AM - 9:45AM Speakers Oren Glanz Lempo Therapeutics Ltd. Synthetic Biologics, Inc. Steven Shallcross, Synthetic Biologics, Inc. show more Session Description Synthetic Biologics, Inc. is a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients. The Company's lead late-stage candidates are: (1) SYN-004 (ribaxamase) which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics to prevent microbiome damage, C. difficile infection (CDI), overgrowth of pathogenic organisms and the emergence of antimicrobial resistance (AMR), and (2) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). The Company’s preclinical pursuits include an oral formulation of the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases. Time Wednesday, Oct 23 9:30AM - 9:45AM Speakers Steven Shallcross Synthetic Biologics, Inc. VM Oncology Jay Wu, VM Oncology show more Session Description VM Oncology, a clinical-stage precision oncology company, is currently developing a first-of-its-kind, oral, allosteric (non-ATP site) and irreversible, and selective TrkA inhibitor, VMD-928, for tumor-agnostic therapy. VMD-928 is purpose-designed to overcome treatment-resistant ATP-site mutations caused by existing ATP-competitive inhibitors, and to treat cancer beyond fusion-driven tumors with unique built-in-biomarkers. Ongoing P1 study show VMD-928 is safe and well tolerated. Pharmacological and analgesic activities beyond fusion target coverage were observed. Orphan drug designation granted. Strong IP protection with freshly granted COM patents. Further, the anti-inflammatory and analgesic activities make VMD-928 the best partner of choice for the combination therapy with immune checkpoint inhibitors. The company is managed by the same team of VM Pharma whose clinical-stage asset of first-in-class, oral allosteric kinase inhibitors for chronic pain was acquired by Purdue Pharma. Time Wednesday, Oct 23 9:30AM - 9:45AM Speakers Jay Wu VM Oncology
9:45am ACT Genomics Shu-Jen Chen, ACT Genomics Co., Ltd. show more Session Description ACT Genomics is a leading molecular information company, integrating clinical grade next-generation sequencing and proprietary bioinformatics algorithm to guide cancer treatment and accelerate drug development. Company now has NGS labs in Taiwan, Hong Kong and Japan. Our Taiwan lab is accredited by CAP to provide NGS services for clinical cancer genetic testing including bio-informatics. ACT Genomics has the complete product portfolio that covers different stages of cancer management, including cancer prevention, treatment selection, and disease monitoring. We are developing an AI engine to extract valuable information from our cancer genome database enriched with Asian high prevalent tumor to facilitate the decision-making process and to identify novel drug target. Besides next generation sequencing platform, we are dedicated in developing chip-based molecular assays to identify actionable targets and biomarkers that are more feasible and affordable in clinical setting. Time Wednesday, Oct 23 9:45AM - 10:00AM Speakers Shu-Jen Chen ACT Genomics Co., Ltd. Advice on Pitching to Family Offices, Venture Philanthropies, and Other Non-Private Equity Funding Sources Deanna Belsky, Dolby Family Ventures; Bob Crutchfield, BrightEdge Ventures; Charlotte Hubbert, Gates Foundation Venture Capital; Peter Lomedico, JDRF T1D Fund ; Reza Halse, MRLV; Christopher Penland, Cystic Fibrosis Foundation; Maura Little, Cambia Grove show more Session Description With investment on the rise and the biotechnology industry continuously providing enormous reward opportunities, the demographic of investors has started to shift from the typical stakeholder. How should CEOs approach these potential partners and successfully secure a funding round? This session will feature experienced voices explaining the strategies to employ to properly satisfy a potential investor’s expectation and secure the desired capital. Time Wednesday, Oct 23 9:45AM - 10:40AM Speakers Deanna Belsky Dolby Family Ventures Bob Crutchfield BrightEdge Ventures Charlotte Hubbert Gates Foundation Venture Capital Peter Lomedico JDRF T1D Fund Reza Halse MRLV Christopher Penland Cystic Fibrosis Foundation Maura Little Cambia Grove Altimmune Inc. Vipin Garg, Altimmune Inc. show more Session Description Altimmune is a publicly traded (Nasdaq: ALT) clinical stage biopharmaceutical company focused on developing treatments for liver disease and immune modulating therapies. Our diverse pipeline includes next generation peptide therapeutics for NASH (ALT-801) and chronic Hepatitis B (HepTcell), conjugated immunostimulants for the treatment of cancer (ALT-702) and intranasal vaccines (NasoVAX and NasoShield). The Company recently announced an acquisition of Spitfire Pharma Inc. and their NASH product candidate, a fully funded Phase 1b NasoShield trial (BARDA), and the results of a pre-IND meeting on HepTcell. Altimmune has a strong balance sheet with $42 million in cash at June 30, 2019 and is poised for growth in the near term. Time Wednesday, Oct 23 9:45AM - 10:00AM Speakers Vipin Garg Altimmune Inc. Cytonus Therapeutics Inc. Remo Moomiaie-Qajar, Cytonus Therapeutics Inc. show more Session Description Cytonus Therapeutics Inc. is a biopharmaceutical company developing a next-generation Adoptive Cellular Transport platform called Cargocytes™. The San Diego-based company’s proprietary Cargocyte™ platform are cellular-engineered transporters of a multiplicity of therapeutic payloads to tissue in a selective, controllable and potent off-the-shelf cellular therapy for the potential treatment of several disease across multiple therapeutic areas. Cytonus’ initial focus is to advance Cargocyte™ candidates for the treatment of rare and difficult to treat cancers and inflammatory diseases. Time Wednesday, Oct 23 9:45AM - 10:00AM Speakers Remo Moomiaie-Qajar Cytonus Therapeutics Inc. SFA Therapeutics Ira Spector, SFA Therapeutics show more Session Description SFA Therapeutics is a development-stage bio-pharmaceutical startup company focused on a new advancement in the treatment inflammatory diseases, targeting NF-Kb. Chronic inflammation has been implicated in a wide range of diseases, including rheumatoid arthritis, psoriatic arthritis, lupus (SLE), inflammatory bowel disease (IBD), Crohn's Disease, Psoriasis, Liver Disease and even certain forms of cancer. Our small-molecule drugs are derived from natural substances identified at Temple University and enable a new platform for developing treatments potentially aimed at over 65 inflammatory diseases currently afflicting patients; with safer treatments than current therapies. Our initial focus is in Psoriasis and Liver Disease (Hepatitis B, NASH and HCC). Patents have been filed in both diseases, based on animal data in Liver Disease and on a small human trial in Psoriasis. Time Wednesday, Oct 23 9:45AM - 10:00AM Speakers Ira Spector SFA Therapeutics
10:00am Acquist Therapeutics, Inc. Ray Warrell, Acquist Therapeutics, Inc. show more Session Description Acquist develops small molecules that deplete uric acid (UA), an established inflammatory mediator in gout and NASH highly prevalent diseases with grossly unmet needs. Our drugs block lipogenesis and NASH progression in models with elevated UA (~40% of patients). In liver cells, we sharply reduce UA, triglycerides, lipogenesis and inflammation. Our drugs bifunctionally inhibit regulators of both UA production and excretion (xanthine oxidase and URAT1) at potencies greater than (e.g., allopurinol, febuxostat, lesinurad). Our clinical drug prototype reduced UA below targets in 100% of patients. Our executives have extensive experience in drug development. Global composition patents are wholly owned. Optimized for 1st-line, once-daily oral dosing, our lead (ACQT1127) is completing animal tox for IND submission and confirmation of activity in these two biomarker-defined populations. The Company is raising a Series A financing and is interested in meeting with qualified investors/partner. Time Wednesday, Oct 23 10:00AM - 10:15AM Speakers Ray Warrell Acquist Therapeutics, Inc. Brava Diagnostics, Inc. Byron Hewett, Brava Diagnostics, Inc. show more Session Description Brava Diagnostics is developing rapid diagnostic products for the acute care market. Our first in vitro diagnostic applications are for cardiac markers, with a projected worldwide market of $2.45 billion by 2025. Our multiplex point-of-care tests will be used to assess chest pain and shortness of breath in the emergency department. The Company is seeking financing to fund development of its first product, a high-sensitivity troponin test for diagnosis of heart attack. Brava plans to sell the Company to a large diagnostics company within 5 years and expect a valuation in excess of $500 million. Emergency physicians need precise lab results, ideally within 15 minutes, to guide treatment or safe discharge for patients with chest pain. New guidelines are driving the shift to high-sensitivity troponin assays (hs-cTn). Central lab tests suffer from turnaround time of more than an hour. Current point-of-care tests do not meet guidelines. Brava could be among the first. Time Wednesday, Oct 23 10:00AM - 10:15AM Speakers Byron Hewett Brava Diagnostics, Inc. Caribou Biosciences Rachel Haurwitz, CARIBOU BIOSCIENCES, INC. show more Session Description Caribou Biosciences is a leading company in CRISPR genome editing founded by pioneers of CRISPR-Cas9 biology. We are using a next-generation gene editing technology to develop a pipeline of off-the-shelf CAR-T cell therapies for the treatment of cancer. We are also using gene editing to develop novel microbiome based therapies. Our lead product, CB-010, is targeted to CD19 and is being developed to treat selected hematological malignancies. The company is located in Berkeley, California. Time Wednesday, Oct 23 10:00AM - 10:15AM Speakers Rachel Haurwitz CARIBOU BIOSCIENCES, INC. Traffic Thera Nick Davis, Traffic Thera show more Session Description Traffic Thera, Inc. ("Traffic") is an early-stage biotech company that is advancing a technology platform to enable the precision manufacturing of Ab-drug conjugates (ADCs) as targeted therapies for cancer and inflammatory disorders. Traffic has developed a site-specific chemoenzymatic approach that generates homogeneous ADCs with (1) completely controllable conjugation site and ratio, and (2) a diverse range of linker chemistries and toxic payloads. To date, Traffic has secured IP rights to its core technologies, published foundational papers on this novel manufacturing approach, established expertise in the rational design of targeted Ab scaffolds, and is progressing several corporate pharma partnerships to co-develop ADCs from monoclonal and bispecific Abs that have already been advanced through IND-enabling studies. We are seeking seed investors with global professional networks and experience in biologics development, industrial biomanufacturing and clinical trial design. Time Wednesday, Oct 23 10:00AM - 10:15AM Speakers Nick Davis Traffic Thera Vigeo Therapeutics, Inc. Jing Watnick, Vigeo Therapeutics, Inc. show more Session Description Vigeo Therapeutics is a clinical-stage biopharmaceutical company developing novel therapeutics that can effectively treat multiple types of cancer and improve the lives of patients. Time Wednesday, Oct 23 10:00AM - 10:15AM Speakers Jing Watnick Vigeo Therapeutics, Inc.
10:15am AIVITA Biomedical Hans Keirstead, AIVITA Biomedical show more Session Description We have leveraged our expertise with stem cells to develop a broad platform targeting cancer, retinal diseases, and neurodegeneration. In cancer, our technology isolates and propagates tumor-initiating cells responsible for metastases of cancers, to target the full patient-specific antigenic profile of that patient's tumor. In retinal diseases, we have developed a three-dimensional retinal organoid and shown this can be implanted into animals to restore vision. This is an allogeneic product developed from validated and efficient manufacturing of human stem cells, yielding consistent, fully functioning retinal organoids. In neurodegeneration, we have developed a non-cellular, pan-neurotrophic product to treat neurodegenerative diseases. We are targeting Alzheimer’s disease first. Pre-clinical model show that treatment leads to better overall survival of neural cells and expansion of neurites with fewer beta tubulin negative cells. Time Wednesday, Oct 23 10:15AM - 10:30AM Speakers Hans Keirstead AIVITA Biomedical Dalton Bioanalytics Austin Quach, Dalton Bioanalytics show more Session Description Dalton Bioanalytics is a data science company spinning out of UCLA. The expense of blood testing is limiting our access to health information, indirectly harming individuals and also blocking innovation in biomedicine. We are solving this by digitizing blood to cut the costs of multi-biomarker measurement by 80% using LC-MS technology. We aim to make comprehensive health screening and diagnosis affordable, unlocking the future of preventative and precision medicine. Rather than measuring after each blood analyte individually, we use our novel LC-MS based technology to digitize the entire biochemical blood signature including proteins, lipids, electrolytes, and small molecules. Numerous blood test values can then be computationally extracted from this data, eliminating the costs of additional testing. Time Wednesday, Oct 23 10:15AM - 10:30AM Speakers Austin Quach Dalton Bioanalytics Deep Lens, Inc. Simon Arkell, Deep Lens, Inc. show more Session Description Deep Lens™ is an AI company focused on identifying patients for clinical trials using VIPER, an AI-driven, digital pathology cloud platform which for over ten years has allowed pathology groups to collaborate on groundbreaking cancer research across dozens of cancer types. Time Wednesday, Oct 23 10:15AM - 10:30AM Speakers Simon Arkell Deep Lens, Inc. Membio Shane Kilpatrick, Membio show more Session Description Membio is on a mission to eliminate the worldwide shortage of blood by manufacturing it outside the body. Using “bleeding edge” technologies we can make an unlimited supply of fully functional and universally accepted red blood cells. All pun’s aside, we are able to make this work by removing the need for a donor by using an “immortalized” cell line which can replicate indefinitely before transforming in a red blood cell. By combining these immortalized cells with Membio’s cell therapy manufacturing technology enables us to unlock cost-effectively production of red blood cells on an industrial scale. Time Wednesday, Oct 23 10:15AM - 10:30AM Speakers Shane Kilpatrick Membio Vita Therapeutics Douglas Falk, Vita Therapeutics show more Session Description Vita Therapeutics is a company out of Johns Hopkins that has a patented cell-based therapy that has shown impressive preclinical curative results in muscular dystrophy. Using induced pluripotent stem cells (iPSCs), they have derived human satellite cells, which have shown the ability to sustainably repair and replace muscle over time. This therapy also has the potential to positively impact all degenerative muscular diseases, chemotherapy-induced cachexia, and geriatric conditions. In addition to this, Vita has a separate molecular compound that have also shown preclinical efficacy in MD (muscular dystrophy) models. The company is currently preparing an IND (Investigational New Drug Application) for its lead therapy with the FDA and plans to submit in 2021. The company recently completed a bridge funding and intends to start a Series A round shortly. Time Wednesday, Oct 23 10:15AM - 10:30AM Speakers Douglas Falk Vita Therapeutics
10:30am AEON BioPharma, Inc. Marc Forth, AEON BioPharma, Inc. show more Session Description An emerging, global biopharma company established to independently pursue the rapidly growing, multi-billion-dollar therapeutic toxin market. Time Wednesday, Oct 23 10:30AM - 10:45AM Speakers Marc Forth AEON BioPharma, Inc. Avail Bio Nima Emami, Avail Bio show more Session Description Immunotherapy is revolutionizing cancer treatment. By activating a patient’s own immune system to fight off their tumor, clinicians are now saving or extending the lives of patients with advanced-stage and metastatic cancer. Yet, in spite of its major health impact, immunotherapy has also brought new growing pains. These include (a) low response rates and (b) risk of severe autoimmune side effects. To provide a better immunotherapy roadmap for patients, clinicians, and biopharma, Avail is leveraging a new genomic technology to profile the immune system of a cancer patient. Avail's blood-based biomarker discovery platform is designed to better estimate the likelihood of clinical benefit for immunotherapy, and is based on years of research at UCSF. With support from Illumina Accelerator and institutional venture capital, Avail is collaborating with genomic scientists, industry leaders, and oncologists around the country to build better solutions for patients, practitioners, and pharma. Time Wednesday, Oct 23 10:30AM - 10:45AM Speakers Nima Emami Avail Bio InMed Pharmaceuticals Inc Eric Adams, InMed Pharmaceuticals Inc show more Session Description InMed is a biopharmaceutical company that specializes in the discovery and development of novel, cannabinoid-based therapeutics for the treatment of diseases with high unmet medical need. InMed employs a highly scientific approach to designing and developing medicines, which will help unlock the full potential of cannabinoid pharmaceuticals. One proprietary technology is our bioinformatics platform, which uses a computer-based drug candidate selection process to reach high-probability conclusions from massive, publicly available databases together with an internal library of cannabinoid drug information. InMed is also developing a robust, high-yield, microbial-based biosynthesis process designed to enable the manufacturing of the multitude of cannabinoids (100+) found from natural sources, with significant cost reductions and increased manufacturing capabilities. Time Wednesday, Oct 23 10:30AM - 10:45AM Speakers Eric Adams InMed Pharmaceuticals Inc Mycovia Pharmaceuticals Patrick Jordan, Mycovia Pharmaceuticals show more Session Description At Mycovia, we are passionate about developing novel drugs in areas of unmet medical need, with an initial focus in women’s health. Our lead product candidate, VT-1161, is being developed as a treatment for recurrent vulvovaginal candidiasis (RVVC), a debilitating chronic condition that affects millions of women worldwide. More commonly known as a chronic yeast infection, RVVC can severely impact a woman’s physical and emotional well being, and results in billions of dollars in lost productivity. With no FDA-approved treatments for RVVC in the U.S., there are limited treatment options available for women who experience three or more yeast infections a year. Mycovia currently has three Phase 3 clinical studies being conducted to evaluate VT-1161 for the treatment of RVVC and is on path to be the first FDA-approved treatment for this debilitating disease. Time Wednesday, Oct 23 10:30AM - 10:45AM Speakers Patrick Jordan Mycovia Pharmaceuticals Oncolytics Biotech Inc. Matthew Coffey, Oncolytics Biotech Inc. show more Session Description Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: Time Wednesday, Oct 23 10:30AM - 10:45AM Speakers Matthew Coffey Oncolytics Biotech Inc.
10:45am Foresee Pharmaceuticals Co., Ltd. Lawrence Gan, Foresee Pharmaceuticals Co., Ltd. show more Session Description Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange. Foresee’s R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery technology and derived drug products targeting specialty markets, and its transformative preclinical and clinical first-in-class NCE programs targeting disease areas with high unmet needs. Foresee's product portfolio includes late stage and early stage programs such as FP-001, 6-month and 3-month, stable, ready-to-use versions of leuprolide mesylate depot for injection, for which regulatory submissions are planned in 2020, FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in a Phase 2 proof-of-concept study; FP-045, a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently in planning (Fanconi Anemia; mitochondrial-mediated diseases). Time Wednesday, Oct 23 10:45AM - 11:00AM Speakers Lawrence Gan Foresee Pharmaceuticals Co., Ltd. InterVenn Biosciences Aldo Carrascoso, InterVenn Biosciences show more Session Description InterVenn Biosciences utilizes a proprietary glycoproteomic biomarker interrogation platform using AI and mass spectrometry for next-gen precision medicine. Our applications include diagnostics/prognostics for ovarian, pancreatic, liver, breast and kidney cancer together with applications (using our “Vista” suite of solutions) in treatment prediction/monitoring, immune profiling, patient stratification, and disease progression. Aberrant glycosylation of proteins has been implicated in key steps of disease biology, including the hallmarks of cancer as well as inflammation cascades associated with autoimmunity and aging. Glycoproteins have been analytically and computationally challenging to study at scale. We have built a platform that overcomes these challenges while turning years of computational burden into minutes. We are currently conducting a 3-country clinical trial for our OvCa diagnostic and offer our Vista programs to many biopharma and academic institutions globally. Time Wednesday, Oct 23 10:45AM - 11:00AM Speakers Aldo Carrascoso InterVenn Biosciences MandalMed, Inc. Constance John, MandalMed, Inc. show more Session Description MandalMed is is developing therapeutic products for fibrosis stemming from breakthroughs in innate immunity and glycobiology. MandalMed is seeking funding for completion of preclinical development and Phase 1 clinical trials of a human protein inhibitor of galectin-3, MM-003, which has blockbuster potential in treating cardiac fibrosis after myocardial infarction (MI) and in heart failure. Clinical trials can be biomarker directed because in HF patients an elevated serum level of galectin-3 is indicative of increased mortality, and at the time of MI an increased plasma level is an independent predictor of mortality and HF. Promising data with MM-003 treatment has been obtained in ischemia-reperfusion and permanent ligation models of MI. Current focus is on a large animal model of MI, IND-enabling toxicology, and animal models of liver fibrosis. No therapies are approved for cardiac or liver fibrosis. A small molecule program is aimed at a related target for liver fibrosis. Time Wednesday, Oct 23 10:45AM - 11:00AM Speakers Constance John MandalMed, Inc. Molecular Diagnostics: Drivers of New Investor Interest and Reimbursement Success Alexis Ji, Illumina Ventures; Trevor Martin, Mammoth Biosciences; Karen Richards, Precision for Medicine; Benjamin Soule, Bristol-Myers Squibb; Richard J. Wenstrup, Epic Sciences show more Session Description As the biotechnology industry continues to address unmet medical needs across a wide variety of diseases and disorders, emerging innovative diagnostics methods are paving the way for earlier detection and increased levels of response to treatment. Companion and molecular diagnostics offer advanced methods of identifying biomarkers for cancer and other diseases and allow for the application of bespoke immune-based therapies. Additionally, Diagnostics Analytics deals spiked in the first half of 2019, with 119 deals totaling $2.164 billion, and are predicted to continue a three-year upward trend, according to the Silicon Valley Bank Mid-Year Report 2019. This panel explores the novel drug and product development from diagnostics companies in the industry that drive funding and reimbursement. Time Wednesday, Oct 23 10:45AM - 11:40AM Speakers Alexis Ji Illumina Ventures Trevor Martin Mammoth Biosciences Karen Richards Precision for Medicine Benjamin Soule Bristol-Myers Squibb Richard J. Wenstrup Epic Sciences Sentien Biotechnologies, Inc. Brian Miller, Sentien Biotechnologies, Inc. show more Session Description Sentien Biotechnologies, Inc. is a privately-owned, clinical-stage company developing novel ex-vivo cell therapy applications to treat conditions caused by systemic, immune-mediated inflammation. Sentien’s lead product, SBI-101, encapsulates allogeneic mesenchymal stromal cells (MSCs) within an extracorporeal, hollow-fiber device. This design allows for extended exposure of patient blood to the MSCs, resulting in the dynamic delivery of MSC-secreted factors at doses that are unattainable by direct injection. SBI-101 is being evaluated in a Phase Ib/IIa study in subjects with dialysis-requiring acute kidney injury (AKI-D). An interim readout from the study supports safety and provides early evidence of anti-inflammatory effects consistent with the SBI-101 therapeutic hypothesis. Sentien plans to expand its pipeline to include additional systemic inflammatory indications where single-factor agents have not been effective, in both the acute and chronic disease spaces. Time Wednesday, Oct 23 10:45AM - 11:00AM Speakers Brian Miller Sentien Biotechnologies, Inc. Vaporox Alan Sage, Vaporox show more Session Description Vaporox, Inc.’s Vaporous Hyperoxia Therapy (VHT™), a patented, and FDA-510K-cleared technology, offers a breakthrough in treating 9 different types of skin wounds, including diabetic foot ulcers (DFUs). Clinical trial data has shown that VHT can heal 70% or more of DFUs that have previously resisted standard wound care treatment, and at a much lower cost than less effective methods. Time Wednesday, Oct 23 10:45AM - 11:00AM Speakers Alan Sage Vaporox
11:00am Azure8 Vipula Tailor, Azure8 show more Session Description Azure8 is a US-based, Women-Owned Company and was founded in 2018. Azure8 has a portfolio of innovative and patented technologies. Sonix-A8 is Class II Medical Device designed to prevent & control bacterial Infections before surgery during the surgery and post-surgery without the use of any chemical antiseptics. Our technology platform eliminates all Surgical Site Infections (SSI's) and reduces the bacterial burden (including MRSA) to prevent bacteremia and sepsis post-surgery. Sonix-A8 also can help eliminate catheter-related infections for dialysis patients. Sonix-A8 is a novel and smart medical device that destroys biofilms without developing resistant Superbugs. Time Wednesday, Oct 23 11:00AM - 11:15AM Speakers Vipula Tailor Azure8 Breakthrough Genomics Laura Li, Breakthrough Genomics show more Session Description With Groundbreaking AI, Breakthrough Genomics aims to achieve the impossible: transform the way that genomic data is interpreted so diseases can be predicted and targeted treatments can be discovered. Time Wednesday, Oct 23 11:00AM - 11:15AM Speakers Laura Li Breakthrough Genomics Dia-beat-it Gopika Nair, Dia-beat-it show more Session Description Dia-beat-it is working on providing transformational therapies for patients with diabetes. Current therapeutics only treat the symptoms of the disease without eliminating the underlying cause of the disease. Born out of years of cutting-edge stem cell research at UCSF and seasoned by the UCSF Entrepreneurship center, Dia-beat-it aims to change the paradigm of diabetes therapeutics from that of managing the symptoms to one that offers a cure. Utilizing our revolutionary technology to produce millions of insulin producing cells from human stem cells, we have established a platform to develop novel biologics that help the patient's body regenerate and preserve its own insulin cells. Time Wednesday, Oct 23 11:00AM - 11:15AM Speakers Gopika Nair Dia-beat-it Ilya Pharma Evelina Vågesjö, Ilya Pharma show more Session Description Ilya Pharma develops next-generation biologics for treatment of wounds and skin and mucosa The first indication targeted is treatment of difficult to heal skin wounds in specific populations for accelerated healing, reduced infection rates and minimal scarring. The lead drug candidate, ILP100, being tested in a first in human study, has potential to change the field of wound care and be a significant part in development of next-generation biologics. The second indication targeted is inflammatory bowel disease, this project is currently in research stage. More specifically human therapeutic well-known proteins are delivered on site by living lactic acid bacteria acting like small bioreactors. The company has own drug candidates and a highly skilled international team. Time Wednesday, Oct 23 11:00AM - 11:15AM Speakers Evelina Vågesjö Ilya Pharma NeOnc Technologies Inc Thomas Chen , NeOnc Technologies Inc show more Session Description NeOnc Technologies, Inc. (NTI) is a Phase 2 cancer biotechnology company focused on intranasal (delivery through the nose) inhalation of a highly purified form of monoterpenes (oils from fruits & plants), alone or with other chemotherapeutics (cancer treatment chemicals) agents. The ongoing clinical trial of NEO100 (the company's first compound) treating malignant brain cancer (gliomas) is proving this delivery platform's effectiveness in passing the Blood-Brain Barrier. The results of Phase one are very encouraging and Phase 2 will begin in 30 days. NeOnc has strong patent protection for this platform and many other indications. Time Wednesday, Oct 23 11:00AM - 11:15AM Speakers Thomas Chen NeOnc Technologies Inc
11:15am American Gene Technologies Norman Rogers, American Gene Technologies show more Session Description American Gene Technologies (AGT) is a gene and cell therapy company with a proprietary gene-delivery platform to rapidly develop gene and cell therapies to cure infectious diseases, cancers, and monogenic disorders. The Company’s mission is to transform people’s lives through genetic medicines that rid the body of disease. The Company expects to take its patented lead candidate for an HIV cure into the clinic in 2019. AGT has received five patents for its unique immuno-oncology approach to stimulate the human body’s natural immune system’s gamma-delta (γδ) T cells to destroy a variety of solid tumors. The Company has also developed a synthetic gene which it expects to cure Phenylketonuria (PKU), a debilitating rare disease. AGT’s treatment for PKU has been granted an Orphan Drug Designation by the Food and Drug Administration (FDA) and it is expected to reach the clinic in 2020. Time Wednesday, Oct 23 11:15AM - 11:30AM Speakers Norman Rogers American Gene Technologies Arcturus Therapeutics Joseph Payne, Arcturus Therapeutics show more Session Description Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) is an RNA medicines company with enabling technologies – LUNAR® lipid-mediated delivery and Unlocked Nucleomonomer Analog (UNA) chemistry – and mRNA drug substance along with drug product manufacturing. Arcturus’ diverse pipeline of RNA therapeutics includes programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, Glycogen Storage Disease Type 3, Hepatitis B, and non-alcoholic steatohepatitis (NASH). Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus technologies are covered by its extensive patent portfolio (167 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA the Time Wednesday, Oct 23 11:15AM - 11:30AM Speakers Joseph Payne Arcturus Therapeutics CohBar Steven Engle, CohBar show more Session Description CohBar (CWBR) is a clinical stage biotechnology company focused on the development of mitochondrial-based therapeutics for the treatment of age-related diseases and extending healthy lifespan. Time Wednesday, Oct 23 11:15AM - 11:30AM Speakers Steven Engle CohBar Galimedix Therapeutics, Inc. Hermann Russ, Galimedix Therapeutics, Inc show more Session Description Phase 2 Ophthalmology and Neuroscience company developing a small molecule with unique MOA to provide neuroprotection, restore suppressed visual function, and to slow progression in dry AMD and glaucoma. Licensed from Tel Aviv University, GAL-101 has high affinity/specificity to misfolded amyloid beta, to block formation of toxic oligomers and reduce their toxicity to neural tissues. Eye drop administration reproducibly achieved >90% neuroprotection in glaucoma rat models, compelling efficacy evidence in AMD models, strong retinal delivery in monkeys, and safety in completed Phase 1 study (n=70). With a highly experienced top neuropharma team, Galimedix enjoys the support of world leading retinal and glaucoma experts. Raising funds for Phase 2 studies to demonstrate improvement of visual function in dry AMD and in glaucoma, and to develop an oral version for other indications. Time Wednesday, Oct 23 11:15AM - 11:30AM Speakers Hermann Russ Galimedix Therapeutics, Inc Golden Biotechnology Corp. Today Su, Golden Biotechnology Corp. show more Session Description Golden Biotechnology Corporation (GBC), founded in 2002, is a leading innovative drug discovery and evidence-based healthy food supplement manufacturing company in Taiwan, dedicated to enhancing lives by developing high quality products that prevent and treat diseases. In 2006, GBC discovered Antroquinonol® (trade name Hocena®), whose relevant therapeutic areas have been granted more than 120 patents worldwide for its structure, preparation method and best-in-class applications in oncology, cardio-metabolic syndromes, autoimmune diseases and neurodegenerative diseases.     Oncology · NSCLC Phase II in the USA. The results are published through ASCO in May 2019. · Pancreatic cancer phase I/II in USA Cardio-Metabolic Syndromes · Hyperlipidemia phase II Autoimmune Diseases · Atopic Dermatitis phase II Neurodegenerative Diseases · Ongoing pre-clinical study on Alzheimer’s Disease in QUT, Australia under guidance of J&J Time Wednesday, Oct 23 11:15AM - 11:30AM Speakers Today Su Golden Biotechnology Corp.
11:30am Aethlon Medical, Inc. Timothy Rodell, Aethlon Medical, Inc. show more Session Description At Aethlon Medical, we are a leading developer of immunotherapeutic technologies to combat infectious disease and cancer. To augment the body's natural immune defenses, the Aethlon Hemopurifier® eliminates life-threatening disease targets that are often shielded from the immune system and not well addressed by traditional drug therapies. The technology captures circulating viruses, bacterial toxins and cancer promoting exosomes through affinity attachment to a unique structure that cloaks these targets from immune detection. At present, the Hemopurifier® is being advanced under an FDA approved clinical study. Aethlon is also the majority owner of Exosome Sciences, Inc., a company focused on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases. Time Wednesday, Oct 23 11:30AM - 11:45AM Speakers Timothy Rodell Aethlon Medical, Inc. Lung Therapeutics Brian Windsor, Lung Therapeutics show more Session Description Lung Therapeutics (LTI) is a biopharmaceutical company developing therapeutics for orphan, unmet needs in lung injury and disease. The Company’s lead drug, LTI-01, is a pro-enzyme for the treatment of Loculated Pleural Effusion (LPE), a severe consequence of pneumonia for which there is no approved pharmacotherapy. In a completed ex-US clinical trial in patients, LTI-01 was demonstrated safe and effective in clearing LPE, resulting in avoidance of surgery and decreased hospitalization. There are no approved drugs for the treatment of LPE. LTI has received US and EU Orphan Drug Designation for LTI-01. The Company’s second drug, LTI-03, is in development for the treatment of idiopathic pulmonary fibrosis (IPF). LTI-03 is a novel peptide addressing a unique mechanism which both promotes epithelial cell survival as well as destruction of fibroblasts. LTI-03 has been proven safe in GLP tox and is ready to enter clinical trials. LTI is raising funding for clinical trials of both drugs. Time Wednesday, Oct 23 11:30AM - 11:45AM Speakers Brian Windsor Lung Therapeutics TargetGene Biotechnologies Yoel Shiboleth, TargetGene Biotechnologies ltd. show more Session Description TargetGene Biotechnologies has developed and is now seeking to commercialize the most precise and versatile Genome Editing technology. Recently granted and pending patents in US and elsewhere are based on the (pre-CRISPR) 2011 invention of RNA-directed gene-targeting by the Founders. TargetGene’s R&D has created highly specific DNA editing solutions for safer therapeutic applications. The company has strategic partnerships with leading companies for several applications of the technology and is now seeking venture capital. TargetGene is seeking to fund a preclinical to clinical pipeline for the treatment of Orphan diseases subsequently translatable to hugely lucrative cures of highly prevalent immune disorders. TargetGene’s platform TGEE technology serves as a programmable molecular “DNA scissors” and incorporates a dual RNA "Guiding System", akin to programming software, which targets it to the precise location in the Genome. The company is located in Rehovot, Israel Time Wednesday, Oct 23 11:30AM - 11:45AM Speakers Yoel Shiboleth TargetGene Biotechnologies ltd. TVAX Biomedical Wayne Carter, TVAX Biomedical show more Session Description TVAX Biomedical is a privately held cancer immunotherapy company planning a Ph 2b pivotal study in brain cancer for accelerated approval. TVAX immunotherapy is specifically an autologous vaccine enhanced adoptive T cell therapy. We have efficacy in late stage recurrent high grade glioma and metastatic renal cell carcinoma. We are planning a Ph 2b study in high grade astrocytoma and seeking a strategic and lead investor for this pivotal study. Time Wednesday, Oct 23 11:30AM - 11:45AM Speakers Wayne Carter TVAX Biomedical Zenith Epigenetics Sanjay Lakhotia, Zenith Epigenetics show more Session Description Zenith Epigenetics Ltd. is a clinical stage biotechnology company developing best in class bromodomain (BET) inhibitors for the treatment of cancer and other disorders with significant unmet medical need. Our goal is to be a leading epigenetic company translating bromodomain biology into impactful therapies. Time Wednesday, Oct 23 11:30AM - 11:45AM Speakers Sanjay Lakhotia Zenith Epigenetics
12:00pm Fireside Chat: Wende Hutton, General Partner, Canaan Wende Hutton, Canaan; Chris Ehrlich, Locust Walk show more Session Description . Time Wednesday, Oct 23 12:00PM - 1:25PM Speakers Wende Hutton Canaan Chris Ehrlich Locust Walk
1:45pm Separating Artificial Intelligence Hype from Real Utility in Drug Development JC Simbana, Pacific Western Bank (Square 1 Bank); Josep Bassaganya-Riera, Landos Biopharma; Gini Deshpande, NuMedii; Bill Martin, Blackthorn Therapeutics; Krishnan Nandabalan, InveniAI; BioXcel Corporation ; Alice Zhang, Verge Genomics show more Session Description Recent data shows venture investment in AI-focused biopharma companies reached a new high of $1.4B through the first half of this year, according to CB Insights. However, the wide variance in applications and algorithms has complicated the ability to map progress in drug development techniques. As leaders in this space now begin to point to molecules moving into development and early clinical results, the prioritization of tools for other biotechs to consider adopting becomes clearer. This session will examine where AI can improve current drug discovery and development versus technological promises that are still years away from delivery. Moderator: JC Simbana, Senior Vice President, Venture Capital Relationships & Healthcare Banking, Pacific Western Bank Time Wednesday, Oct 23 1:45PM - 2:40PM Speakers JC Simbana Pacific Western Bank (Square 1 Bank) Josep Bassaganya-Riera Landos Biopharma Gini Deshpande NuMedii Bill Martin Blackthorn Therapeutics Krishnan Nandabalan InveniAI; BioXcel Corporation Alice Zhang Verge Genomics
2:00pm Boundless Bio, Inc. Zachary Hornby, Boundless Bio, Inc. show more Session Description Boundless Bio, a San Diego based company backed by ARCH Venture Partners, City Hill Ventures, Vertex Ventures, Tavistock, GT Healthcare, and Alexandria Venture Investments is discovering and developing novel cancer therapeutics based on the role of extrachromosomal DNA (ecDNA) in driving tumorigenesis, resistance and recurrence. When DNA in cancer cells comes off chromosomes, “extrachromosomal DNA (ecDNA),” it becomes unbound and unwound, thereby enabling numerous copies of cancer-causing genes, driving cancer cells to grow and allowing them to resist treatment. At Boundless Bio, we are counterattacking this ecDNA phenomenon with boundless innovation and boundless energy to develop powerful new cancer medicines that eliminate cancer cells’ ability to employ ecDNA to survive. Targeting ecDNA represents the next revolution in delivering transformative medicines that improve the lives of patients with cancer. Time Wednesday, Oct 23 2:00PM - 2:15PM Speakers Zachary Hornby Boundless Bio, Inc. IMV Inc. Frederic Ors, IMV Inc. show more Session Description IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Time Wednesday, Oct 23 2:00PM - 2:15PM Speakers Frederic Ors IMV Inc.
2:15pm Bipharm LLC Andrey Boldyrev, Bipharm show more Session Description Bipharm is an innovative preclinical stage biotech company developing potent small molecules that inhibits chromosomal instability in cancer by the interaction between Hec1 and Nek2 proteins. Those proteins play a pivotal role in the cell division process of healthy cells helping the correct segregation of chromosomes during mitosis. Overexpression of Hec1 and Nek2 results in chromosomal instability (CIN) and aneuploidy in cancer cells. Both proteins are frequently overexpressed in aggressive types of solid tumors, such as triple-negative breast cancer (TNBC), recurrent/resistant colorectal cancer, liver cancer, gastric cancer, pancreatic cancer, lung cancers, and glioblastoma. Time Wednesday, Oct 23 2:15PM - 2:30PM Speakers Andrey Boldyrev Bipharm MetVital, Inc. Alan Cash, MetVital, Inc. show more Session Description MetVital is a clinical-stage, metabolic therapy company developing first-in-class, broadly applicable methods to improve cellular metabolism to ameliorate disease. MetVital is currently studying its lead product candidate, Anhydrous Enol-Oxaloacetate (AEO) in a Phase 1 clinical trial for Amyotrophic Lateral Sclerosis (ALS), and has FDA approval for commercial investigation of Glioblastoma Multiforme (GBM, brain cancer) in a Phase 2 clinical trial. A Phase 2A investigation into Alzheimer's Disease was recently completed and supports further development. MetVital's lead candidate has been designated by the FDA as "Orphan Drugs" for the treatment of GBM and gliomas, ALS and Hepatocellular Carcinoma (Liver Cancer). Time Wednesday, Oct 23 2:15PM - 2:30PM Speakers Alan Cash MetVital, Inc.
2:30pm Oragenics, Inc. Alan Joslyn, Oragenics, Inc. show more Session Description Oragenics, Inc. is focused on becoming a leader in novel antibiotics against infectious disease. The company is currently developing innovative treatments for oral mucositis and infectious disease. Its Phase 2, FDA fast tracked, orphan status oral mucositis program features a live biotherapeutic to deliver trefoil factor to injured tissue, while its antibiotic platform features lantibiotics, which are novel peptide anti-bacterial compounds produced by gram positive bacteria strains that attack disease mitigating bacteria. Oragenics has established two exclusive worldwide channel collaborations with Intrexon Corporation subsidiaries, which will allow Oragenics to accelerate the development of both programs. Time Wednesday, Oct 23 2:30PM - 2:45PM Speakers Alan Joslyn Oragenics, Inc. Rakuten Medical Abhijit Bhatia, Rakuten Medical show more Session Description Rakuten Medical is a privately funded, clinical-stage biotechnology company with offices in the U.S., Japan, Taiwan, Germany and Netherlands. Rakuten Medical aims to become a leader in precision-targeted medicines through its proprietary photoimmunotherapy platform, which is being studied in ongoing clinical trials, evaluating its safety and effectiveness as a cancer-treatment option that can be administered independently, or in combination with other drugs. Rakuten Medical’s lead product, ASP-1929, has achieved Fast Track designation from both the FDA and the Japanese Ministry of Health, Labour, and Welfare; and is conducting a global Phase 3 clinical trial for recurrent head and neck squamous cell carcinoma. Additional Phase 2 studies for ASP-1929 PIT are also underway to evaluate the safety in patients with other cancer types. For more information, visit Time Wednesday, Oct 23 2:30PM - 2:45PM Speakers Abhijit Bhatia Rakuten Medical
2:45pm Best Practices in Biopharma Alliances with Digital Therapeutics Partners David B. Klein, Click Therapeutics; Megan Zweig, Rock Health; Selina Koch, BioCentury Inc.; Matt Cook, Omada Health; Ruchita Sinha, Sanofi Ventures; Javier Garcia Palacios, Bayer show more Session Description As the FDA has standardized the approval pathway for digital therapeutics, an increasing number of such therapies are reaching patients, often in collaboration with existing biopharma companies. Rock Health released an in-depth study earlier this year identifying four success factors that must be shared for such partnerships: value proposition of the project, organizational commitment, evidence standards, and channel strategy with business model. This session will feature Rock Health’s specific data then discuss the opportunities and challenges with digital therapeutics and biopharma alliance partners themselves. Time Wednesday, Oct 23 2:45PM - 3:55PM Speakers David B. Klein Click Therapeutics Megan Zweig Rock Health Selina Koch BioCentury Inc. Matt Cook Omada Health Ruchita Sinha Sanofi Ventures Javier Garcia Palacios Bayer MAIA Biotechnology, Inc. Joe Dillon, MAIA Biotechnology, Inc. show more Session Description MAIA Biotechnology, Inc. is a cutting-edge, early stage biotech company, dedicated to developing targeted cancer therapies with novel mechanisms of action that are intended to meaningfully improve and extend the lives of patients with cancer. A privately-held company based in Chicago and Houston, MAIA is led by a passionate, principled and dynamic management team with significant drug development experience, committed to advancing promising agents into trials in humans in the next 2-3 years. Time Wednesday, Oct 23 2:45PM - 3:00PM Speakers Joe Dillon MAIA Biotechnology, Inc. Xenetic Biosciences, Inc. Jeffrey Eisenberg, Xenetic BioSciences, Inc. show more Session Description Xenetic Biosciences, Inc. (NASDAQ: XBIO) is a biopharmaceutical company focused on progressing XCART, a personalized CAR T platform technology engineered to target patient-specific tumor neoantigens. The Company is initially advancing cell-based therapeutics targeting the unique B-cell receptor on the surface of an individual patient’s malignant tumor cells for the treatment of B-cell lymphomas. XCART has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications. Additionally, Xenetic is leveraging PolyXen™, its proprietary drug delivery platform, by partnering with biotechnology and pharmaceutical companies. PolyXen™ has demonstrated its ability to improve the half-life and other pharmacological properties of next-generation biologic drugs. The Company has an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and expects to earn royalty payments under this agreement. Time Wednesday, Oct 23 2:45PM - 3:00PM Speakers Jeffrey Eisenberg Xenetic BioSciences, Inc.
3:00pm DotBio Pte. Ltd. Ignacio Asial, DotBio Pte. Ltd. show more Session Description DotBio focuses on the development of multi-functional antibodies with synergistic activities to cure cancer. DotBio's approach involves the use of its modular DotBody technology platform, high-throughput miniaturized assays and pattern-recognition algorithms to generate molecules with unique modes of action. DotBio secured USD 2.3 M in Seed funding in 2018, and is now raising USD 20 M in Series A to bring its capabilities to the next level: increase throughput, improve data analytics capabilities and bring three molecules towards the clinic through partnerships. Time Wednesday, Oct 23 3:00PM - 3:15PM Speakers Ignacio Asial DotBio Pte. Ltd. Impact Therapeutics Jun Bao, Impact Therapeutics show more Session Description Impact Therapeutics is a privately held clinical-stage biopharmaceutical company incorporated in Nanjing, China, dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. We have assembled most comprehensive global DNA damage response (DDR) pipeline of novel drug candidates generated by in-house discovery platform. We are now expanding drug discovery platform to other novel synthetic lethality targets. Impact has made tremendous progress in several drug discovery projects, including PARP inhibitor, Wee1 inhibitor, other novel DDR agents and Hedgehog pathway inhibitor. The lead program PARP inhibitor IMP4297 is ready for Phase 3 study in China. Preliminary clinical data demonstrated better safety profile and wider therapeutic window. Wee1 inhibitor IMP7068 is undergoing IND enabling studies. Time Wednesday, Oct 23 3:00PM - 3:15PM Speakers Jun Bao Impact Therapeutics
3:15pm Felix Biotechnology Robert McBride, Felix Biotechnology show more Session Description Felix Biotechnology is accelerating the development and deployment of novel biotherapeutics to treat life-threatening microbial infections in human health. Our core technology is consists of synthetic biology platforms licensed from Berkeley allowing for discovery and engineering of these novel molecules as well as a preclinical asset licensed from Yale University. Our technology has currently been deployed to treat MDR and PDR Pseudomonas aeruginosa infections in 10 cystic fibrosis patients using a compassionate use IND. These treatments have all been safe, and have positive primary and secondary clinical outcomes. We have additional candidates targeting S. aureus and MRSA infections, as well as candidates targeting Burkholderia and Acinetobacter infections. Additionally, we have some discovery biotherapeutics targeting clinically important fungal infections. Time Wednesday, Oct 23 3:15PM - 3:30PM Speakers Robert McBride Felix Biotechnology xCella Biosciences Jennifer Cochran, xCella Biosciences show more Session Description xCella Biosciences is an integrated oncology drug discovery and development company combining cutting-edge protein engineering technologies with deep biological insights. Our novel antibody discovery platforms (xEmplar™ and xPloration™) unlock and accelerate the development of next-generation therapeutics that harness the innate and adaptive immune systems. Now completing IND‐enabling studies, our lead molecule XC201 is a novel biologic that combines with checkpoint inhibitors and immune modulatory agents to potentiate macrophage and T-cell directed immunotherapy against a wide variety of tumors. Additionally, our synergistic pre‐clinical pipeline of antibodies consists of potent agonists and inhibitors of underexplored and emerging oncology targets. In partnership with leading biopharmaceutical companies, xCella is also pursuing discovery programs against challenging targets and pathways. Time Wednesday, Oct 23 3:15PM - 3:30PM Speakers Jennifer Cochran xCella Biosciences
3:30pm AsiaBiome Jonathan Krive, AsiaBiome show more Session Description AsiaBiome is a pre-clinical stage biotech using Asia-sourced data to accelerate the discovery of microbiome based therapeutics. We create IP for a new class of drugs to license to large Pharma companies globally. We currently have programs in diabetes, IBS, autism, and oncology. Time Wednesday, Oct 23 3:30PM - 3:45PM Speakers Jonathan Krive AsiaBiome
4:00pm Market Outlook-Taking the Temperature of the IPO Market in an Era of Large Pharma M&A Megan Zweig, Rock Health; Jim Healy, Sofinnova; Greg Wade, BTIG; John Kollins, Satsuma Pharmaceuticals, Inc.; Sara Michelmore, MacDougall; Siobhan Pomeroy, Gilead Sciences show more Session Description As we start to close out 2019, the mixed signals regarding the appetite for IPOs are off from 2018’s strong finish. This year’s 33 offerings in the 1H have totaled $2.992 billion, compared to the $3.484 billion seen in the 35 offerings from last year. Large pharma M&A deals, however, continue to surprise and raise questions about a temporary market shift or a lasting trend. With market volatility also on the rise aided by continued global trade tensions, the second half of 2019 raises concerns about the endurance of high valuations. This session will examine the path forward while highlighting the availability of quality targets in the market. Time Wednesday, Oct 23 4:00PM - 4:55PM Speakers Megan Zweig Rock Health Jim Healy Sofinnova Greg Wade BTIG John Kollins Satsuma Pharmaceuticals, Inc. Sara Michelmore MacDougall Siobhan Pomeroy Gilead Sciences


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