About Tolerion

Tolerion is a clinical-stage biopharmaceutical company using our proprietary therapeutic platform to develop a pipeline of novel products to treat autoimmune diseases in a fundamentally new manner.

Our product candidates are designed to selectively eliminate specific, harmful immune responses while leaving the rest of the immune system intact, a state known as “tolerance”. This targeted and selective approach will lead to improved efficacy, safety and tolerability relative to current therapies.

Currently there are no approved therapies that restore tolerance in autoimmune disease. Our lead product candidate, TOL-3021, for the treatment of type 1 diabetes, has completed a Phase 2a clinical trial.

Based on our discussions with FDA, we believe that our next trial for TOL-3021 could be a pivotal clinical trial. Our second product candidate, TOL-3034, for the treatment of myasthenia gravis, is in preclinical development. We own all worldwide marketing, distribution and manufacturing rights to each of our product candidates.

Management

Larry Steinman

Larry Steinman

Founder and Executive Chairman
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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.

Alexander (“Zan”) Fleming

Alexander (“Zan”) Fleming

President and CEO
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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.

Nigel Ray

Nigel Ray

Founder and COO
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Mr. Ray is a founder of Tolerion and has over 30 years of transactions, commercial operations, and marketing experience in pharmaceutical and biotechnology companies. Prior to Tolerion, Mr. Ray was Vice President of Global Licensing at Aptalis Pharmaceuticals. Previously, Mr. Ray led business development at Atreca, AcelRx Pharmaceuticals, Limerick Biopharma, and DURECT, and he led marketing at ALZA.

Mr. Ray received a BA in human biology from Stanford University and an MBA from the Anderson School of Business at the University of California, Los Angeles.

Tolerion Board of Directors

Larry Steinman

Founder and Executive Chairman
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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.

Paul Manning

PBM Capital
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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 Salfort

PBM Capital
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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.

Alexander (“Zan”) Fleming

President and CEO
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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.

Nigel Ray

Founder and COO
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Mr. Ray is a founder of Tolerion and has over 30 years of transactions, commercial operations, and marketing experience in pharmaceutical and biotechnology companies. Prior to Tolerion, Mr. Ray was Vice President of Global Licensing at Aptalis Pharmaceuticals. Previously, Mr. Ray led business development at Atreca, AcelRx Pharmaceuticals, Limerick Biopharma, and DURECT, and he led marketing at ALZA.

Mr. Ray received a BA in human biology from Stanford University and an MBA from the Anderson School of Business at the University of California, Los Angeles.

Scientific Advisory Board

Bruce Buckingham, M.D.

Bruce Buckingham, M.D.

Professor of Pediatrics/p>

  • Diabetes research in children, particularly continuous glucose monitoring and immune intervention
  • Decade of clinical trial experience
Stephen Gitelman, M.D.

Stephen Gitelman, M.D.

Professor of Pediatrics/p>

  • Research on cause for immune mediated destruction of insulin producing beta cells
  • TrialNet center director
  • Immune Tolerance Network investigator
Kevan Herold, M.D.

Kevan Herold, M.D.

Professor of Immunobiology and Medicine/p>

  • TrialNet program leader
  • Part of team to 1st report use of anti-CD3 mAB
John M. Lachin, Sc.D.

John M. Lachin, Sc.D.

Professor of Biostatistics and Epidemiology/p>

  • Principle investigator of Center for the Epidemiology of Diabetes Intervention (EDIC) study and Glycemic Reduction Approaches in Diabetes (GRADE)
Darrell Wilson

Darrell Wilson

Stanford University
Professor of Pediatrics, Chief of Division of Pediatric Endocrinology and Diabetes/p>

  • Principal investigator of Stanford Center for NIH-funded Type-1 diabetes TrialNet group