Tolerion is a clinical-stage biopharmaceutical company with a product portfolio built around our novel antigen-specific immune tolerance induction platform. Our first three named product candidates, one in late stage clinical trials, address autoimmune disorders with candidates invented with our proprietary platform. Our fourth program, a monoclonal antibody for treatment of ALS, inhibits a novel integrin discovered by Larry Steinman and benefits from his lifetime of work in integrin biology, including his role in the discovery and development of integrin inhibitor, Tysabri®.
We engineer product candidates that restore balance in autoimmune conditions in which self-antigens (or “autoantigens”) incite a destructive immune response. This approach has the important benefits of targeting the root of the pathogenic immune response without impairing healthy immune function more broadly. This affords significant efficacy and safety advantages relative to other approaches in development. This approach has been validated in human clinical trials with two platform products. Both products showed positive changes in markers of immune response and correlative changes in clinical efficacy endpoints.
Currently there are no approved therapies that restore balance in autoimmune disease. Our lead product candidate, TOL-3021, for the treatment of type 1 diabetes, has successfully completed a Phase 2a clinical trial and is moving into advanced clinical development. TOL-3034 and TOL-3052 are our clinical development candidates to treat myasthenia gravis and neuromyelitis optica, respectively – two orphan diseases with very well-established causal autoantigens. Both TOL-3034 and TOL-3052 are rapidly advancing toward clinical development.
25 years of experience in biotechnology industry, with focus on company formation, strategic planning, capital raising, and strategic transaction execution. After beginning his career in life sciences investment banking at Vector Securities (acquired by Prudential) and Banc of America Securities, John transitioned to operating roles with escalating responsibilities at InterMune (acquired by Roche), CoMentis, Alios BioPharma (acquired by JNJ) and Tioma Therapeutics before joining Tolerion in January 2019.
George A. Zimmermann Professor of Neurology and Pediatrics Stanford. Member of the National Academy of Sciences, and the National Academy of Medicine. Senior author on the 1992 Nature article that led to the drug Tysabri®, approved for MS and Crohn’s disease. Numerous honors, including the John M. Dystel Prize, the Javits Neuroscience Investigator Award from the NINDS twice, the Charcot Prize in MS research, and the Cerami Prize in Translational Medicine. Cofounded several biotech companies, including Neurocrine, Atreca, Katexco, and Tolerion. Director of Centocor from 1988 until its sale to JNJ. Graduated from Dartmouth College in Physics and MD from Harvard Medical School.
40+ years of experience in medicine, clinical research and regulatory affairs. US FDA from 1986-98, responsible for the therapeutic areas of diabetes, other metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive indications. Led reviews of landmark approvals including metformin and the first statin, insulin analog, PPAR-agonist, and growth hormone for non-GH deficiency indications. Lead author of the book, Optimizing Development of Therapies for Diabetes. M.D. and internal medicine training from Emory, fellowship training in endocrinology at Vanderbilt and metabolism at National Institutes of Health, where he was a senior fellow.
Randy joined Tolerion as Chief Scientific Officer May 2019 with 25+ years tenure in discovering and developing drugs to commercialization with preeminent pharmaceutical and biotechnology companies (Amgen, Roche Bioscience, Genentech, Syntex) including entrepreneurial start-up ventures (KAI Pharmaceuticals, Cellgate, Durect, Statim Pharma). Dr. Johnson’s R&D efforts throughout his career contributed delivery of 3 FDA-approved and successfully marketed drugs, Herceptin®, Aloxi®, and Parsabiv® treating patients in oncology and end-stage renal disease together generating over $2 Billion in annual sales. Dr. Johnson has a record of raising over $130 Million in capital funds, filed 11 INDs, patented inventor on 13 U.S. and international patents and author of over 120 scientific publications, abstracts and book chapters. Prior to industry, Dr. Johnson was Research Assistant Professor, Department of Pharmacology, University of Virginia School of Medicine where he also did his postdoctoral fellowship in molecular pharmacology. Dr. Johnson holds a Ph.D. in Biomedical Sciences-Pharmacology, from the University of South Carolina School of Medicine (Distinguished Graduate Doctoral Alumni), an M.A in Biology, B.S. in Zoology from California State University Long Beach. He is a full member of ASPET (Emeritus), ASBMB, SFN, ES, AAAS, and CAS.
35+ years of experience in biopharmaceutical product development, formulation development and manufacturing. Broad experience spanning a wide range of product types including small molecules, therapeutic proteins/hormones, monoclonal antibodies, oncolytic viruses and plasmids. Chief Technology Officer at Iconic Therapeutics, VP CMC at Bavarian Nordic, SVP of Manufacturing at CytRx Corporation. M.S. Microbiology from Texas A&M
15+ years of life science industry experience in operating, venture capital and management consulting roles. Chief Business Officer at Tioma Therapeutics, VP Strategy and Business Development at Alios Biopharma (acquired by JNJ) and Principal at Essex Woodlands Healthcare Partners. Former commissioned officer in the U.S. Air Force, Lecturer at Stanford University in the Department of Medicine, Division of Clinical Pharmacology in the School of Medicine, MBA Tuck School of Business at Dartmouth.
Mr. Donovan has served as President & CEO since joining the company in January 2019. Mr. Donovan has over two decades of life sciences industry experience, first as an investment banker working with life sciences clients and then in operating roles as a member of senior leadership within several biotechnology companies. Prior to joining Tolerion, Mr. Donovan was President and CEO of Tioma Therapeutics, a privately-owned biotechnology company focused on developing immunotherapeutic anti-cancer antibodies. Prior to that he was a co-founder and CBO of Alios BioPharma, a privately-owned biotechnology company (purchased by Johnson and Johnson) focused on drug discovery and development of new therapies to treat a range of infectious diseases. Prior to Alios, Mr. Donovan was CFO at CoMentis, a privately-owned biotechnology company focused on developing treatments for Alzheimer’s Disease and age-related macular degeneration. Previous to that he was head of Strategic Planning & Corporate Communications at InterMune, a publicly traded biotechnology company (subsequently acquired by Roche). Mr. Donovan began his career as a corporate investment banker, first at Vector Securities International, a boutique life sciences investment bank, then at Banc of America Securities, a global, full-service investment bank. He received his Bachelor in Business Administration from the University of Notre Dame.
Dr. Fleming is a noted clinical and regulatory expert and a passionate advocate for development of treatments for type 1 diabetes. From 1986-98, Dr. Fleming oversaw clinical review of diabetes, other metabolic and endocrine products at the Food and Drug Administration, including landmark approvals of the first statin, insulin analog, metformin, and PPAR-agonist. He was responsible for the regulation of the earliest biotech products including human insulin and growth hormone. He helped to shape FDA policies and practices related to therapeutic review, regulatory communication, and knowledge management. Dr. Fleming represented the Agency internationally, including an assignment to the World Health Organization in 1991-92 and membership on several expert working groups of the International Conference on Harmonization (ICH), including Good Clinical Practices and General Considerations for Clinical Trials.
Dr. Fleming continues to publish scientific articles, commentaries, and book chapters. He has served on many corporate and professional society advisory boards, including the Juvenile Diabetes Research Foundation, European Association for the Study of Diabetes and American Diabetes Association. With Executive Chairman, Dr. Larry Steinman, he organized in 2017 the First Congress on Metabesity in London—an effort aimed at catalyzing development of products for prevention of the major noncommunicable diseases including diabetes and the aging process itself.
Before joining Tolerion, Dr. Fleming led Kinexum, a multidisciplinary strategic advisory firm that he founded in 2002, which has served over 400 companies with products ranging from conventional pharmaceuticals to complex molecules, cell therapies, medical devices and digital technologies across multiple therapeutic areas. Dr. Alexander Fleming received his M.D. and internal medicine training from Emory, fellowship training in endocrinology at Vanderbilt and metabolism at National Institutes of Health, where he was a senior fellow before joining FDA.
Paul Manning is the President and CEO of PBM Capital Group based in Charlottesville, VA. An entrepreneur with thirty years of experience in the healthcare industry, Paul founded PBM Capital Group in 2010, a private equity investment firm in the business of investing in health care and life-science related companies. Paul directs all investment decisions and sits on the Board of Directors for many of PBM Capital’s investments including: Avexis, Dova Pharmaceuticals, Verrica Pharmaceuticals, and PBM Pharmaceuticals.
Paul has successfully founded several companies that developed and distributed prescription and over the counter products to major chains in the United States.
In 1997, Paul founded PBM Products, which became the largest private label producer of infant formula and baby/toddler food in the world. PBM Products was sold to Perrigo Corporation in 2010. Paul served on Perrigo Corporation’s Board of Directors after the sale.
Paul is an active member of the University of Virginia community, having served on the Board of UVA Strategic Planning Committee, the Board of UVA Health Foundation, and the Board of the President’s Advisory Committee.
Paul graduated from the University of Massachusetts with a B.S. in Microbiology. Paul was named Virginia Entrepreneur of the Year by Ernst and Young in 2002.
Sean Stalfort is a Principal of the PBM Capital Group where he sources and structures new investment opportunities, oversees many of the portfolio companies and serves on the Board of Directors for Dova Pharmaceuticals, Verrica Pharmaceuticals, Xalud Therapeutics, and Quantapore, Inc. Prior to joining PBM Capital, Sean was the Executive Vice President for New Business Development/M&A for PBM Products where he sourced and managed new growth opportunities internationally as well as various capital market activities through the sale of the company to Perrigo Corporation for over $800 million.
Sean is also a founding partner of Octagon Partners and Octagon Finance, historic tax credit real estate companies. Previously, Sean was a founding Principal and Senior Vice President of Capital Markets with Enterprise Mortgage, a specialty finance company which provided over $1.5 billion in senior cash flow debt financing to small and mid-sized companies and properties and a Vice President in Greenwich Capital’s Asset-Backed Finance Group where he structured over $2 billion in various securitized transactions. Sean started his career as an investment banking associate at CS First Boston in New York.
Sean graduated from Brown University with a B.A. in Business Economics and Political Science.
Dr. Steinman is a founder of Tolerion and is currently the George A. Zimmermann Professor of Neurology and Neurological Sciences and Pediatrics in the Stanford University School of Medicine. From 2002 to 2011, Dr. Steinman chaired the Stanford University Program in Immunology. Research in his laboratory led to the development of the blockbuster drug Tysabri® (natalizumab), which is used to treat patients with the autoimmune diseases multiple sclerosis and Crohn’s Disease. He has received numerous awards for his research and has been elected to both the National Academy of Sciences and
the National Academy of Medicine.
Dr. Steinman served on the board of directors and headed the scientific advisory board at Centocor for ten years, until the company was acquired by Johnson & Johnson. Dr. Steinman also co-founded and served as a director of Atreca, Neurocrine Biosciences and Bayhill Therapeutics, and he co-founded Nuon Therapeutics. Dr. Steinman received a BA from Dartmouth College and an MD from Harvard University.
Professor of Pediatrics
Professor of Pediatrics
Professor of Immunobiology and Medicine
Professor of Biostatistics and Epidemiology
Professor of Pediatrics, Chief of Division of Pediatric Endocrinology and Diabetes