Francisco Leon
Founder, CEO, Chairman @ Tolerance Bio
About
I am passionate about translational research in Immunology, about innovation and disruptive ideas which may help people in need. An immunologist by training, my career is highlighted by several successful entrepreneurial pursuits, including Provention Bio, which I co-founded and served as Chief Scientific Officer (acquired by Sanofi in 2023) and Celimmune, which I co-founded and served as CEO and Chief Medical Officer (acquired by Amgen in 2017). My scientific and corporate mission is the development of interventions to restore immune balance, intercepting or preventing immune-mediated diseases. Experienced in the main areas of immunology: Immunodeficiencies, allergy, infectious diseases, immuno-oncology, transplantation and, in particular, autoimmunity and vaccines. I have led R&D projects and teams in diverse settings from start-ups to Big Pharma and am fluent in all phases of drug development and commercialization. I have expertise in the design and execution of strategies and trials for rapid and cost-effective de-risking of experimental medicines and solutions ("rapid go/no-go"). I have authored or co-authored over 100 peer-reviewed articles, book chapters and patents. And I have led or participated in the development of several approved products: Provention's teplizumab/TZIELD®, AZ’s benralizumab/FASENRA®; BMS's abatacept/ORENCIA®, belatacept/NULOJIX®; and Janssen’s ustekinumab/STELARA® and guselkumab/TREMFYA®.
United States
Washington DC-Baltimore Area
Pharmaceuticals
Clinical Trials, Immunology, Clinical Development, Biologics, Drug Development, Vaccines, Molecular Biology, Asthma, Oncology, Infectious Diseases, Biomarker Discovery, Transplant, Laboratory, Validation, Autoimmune Diseases, GCP, Biochemistry, Hospitals, Drug Discovery, Cancer
Experience

Founder, CEO, Chairman
Philadelphia, Pennsylvania, United States
Founder and CEO of Tolerance Bio, a biotech start-up focused on improving healthspan by restoring and preserving the function of the thymus, a key regulator of immune tolerance. https://www.tolerancebio.com/

Founding Partner, Board Director
Seville, Spain
Vaxdyn is a biotechnology company located in Seville, Spain, developing a vaccine platform for antibiotic-resistant bacteria, such as Klebsiella, Acinetobacter and Pseudomonas. Our goal is to decrease the impact on public health of infections caused by drug-resistant pathogens. https://vaxdyn.com/

Founder, President
PharmImmune
Washington DC-Baltimore Area
Company ideation and personal consultancy firm.

Co-Founder, Partner
Glutenostics
Los Angeles, CA
Glutenostics commercialized rapid gluten detection assays (Gluten Detect Stool and Gluten Detect Urine) to help people avoiding gluten to be more compliant with their diets. As of Nov 2025, operations continue under Biomedal, which commercializes Gluten Detect directly (https://glutendetect.es/en/) and via Amazon.com: - URINE: https://www.amazon.com/Gluten-Detect-Kit-Tests-Gluten-Free/dp/B0FV3F359C/ref=sr_1_4?crid=3CIIHXC2WPB5F&dib=eyJ2IjoiMSJ9.UzbDpoGD_AVa7Ikugn7oUr3inxxcOt_STh9Y3UclCz3KYH-GbZZSc74adoX_oAZW3VdzEiVTQTi5IfeAyoLPODdy_qjLNOrVu2rT-36cyBFcbhceZzeKEowoTdHMGd93vA5G4qsfUjQi9VEyDAxB8jFnxHUo4R-P4fM60zcdPg4XTLlIfSj5vNRpS5rRylz6.OgEP1s37pM6G1GQJTe0Evy6sS0lID6nxFkQ8WcF9I2o&dib_tag=se&keywords=glutendetect&qid=1773599424&sprefix=glutendetect%2Caps%2C133&sr=8-4&th=1 - STOOL: https://www.amazon.com/Gluten-Detect-Kit-Tests-Gluten-Free/dp/B0FT3KFCHY/ref=pd_sbs_d_sccl_2_1/131-2626319-3673309?pd_rd_w=qq1YU&content-id=amzn1.sym.aa738fbd-ad05-4d11-aae2-04b598db6305&pf_rd_p=aa738fbd-ad05-4d11-aae2-04b598db6305&pf_rd_r=M52PVXEC49DZPMG4C3D2&pd_rd_wg=nAD6z&pd_rd_r=f230fb8f-958b-4e1c-b9d4-f62d75b179a7&pd_rd_i=B0FT3KFCHY&psc=1

Chief Scientific Officer, Provention Bio - a Sanofi Company
Boston, Massachusetts, United States
After the acquisition, I help transition and advance the Provention Bio pipeline in Sanofi, focusing on Tzield (PROTECT completion and regulatory activities, intellectual property development, life cycle).

Co-Founder, Chief Scientific Officer
Provention Bio (acquired by Sanofi in 2023)
Red Bank, NJ, USA
Co-Founder, Chief Scientific Officer, former Board Director (2018-2019), former Chairman of the Scientific Advisory Board (2017). Provention Bio was acquired by Sanofi in April 2023. Provention was a clinical-stage biopharmaceutical company dedicated to sourcing, developing and commercializing novel therapeutics and cutting edge solutions to intercept and prevent immune-mediated disease. Our founding mission was to reduce the high-morbidity/mortality and escalating costs of autoimmune and inflammatory diseases, such as type 1 diabetes, celiac disease, Crohn’s disease, ulcerative colitis, lupus and emerging viruses. Our pioneering approach was to “predict” and “pre-empt” immune-mediated disease – to identify at-risk patients and intervene before the targeted disease begins, re-appears or progresses. At Provention, I had the privilege of leading scientific aspects of our programs, with focus on the advancement of teplizumab/TZIELD®, and responsibility for our celiac (PRV-015, anti-IL-15), lupus/gene therapy (PRV-3279, CD32B/CD79B bi-specific) and coxsackie vaccine (PRV-101) programs. I functionally managed Translational Medicine, Biomarkers, Intellectual Property and Pharmacokinetic teams, and supported Business Development, Investor Relations, Corporate Communications and Commercial.
Education

Mucosal Immunology
DPT. OF BIOCHEMISTRY, UAM (mentor: Dr. A. Sillero), and DPT. OF CLINICAL IMMUNOLOGY, HOSPITAL RAMÓN Y CAJAL (thesis director: Dr. G. Roy). Thesis: "New immunological approaches in the diagnosis and pathogenesis of Celiac Disease and other enteropathies" (“Summa Cum Laude”).Courses at the National Center for Biotechnology (CNB) and the Molecular Biology Center (CBM, Cantoblanco Campus, Madrid, 1998-2000).

Allergy and Immunology Residency Program
- UNIVERSITY OF TROMSO, NORWAY: Invited Researcher, Dpt. of Immunology, Institute for Medical Biology [Aug 1993 Sep 1994]. - UNIVERSITY OF OXFORD, ENGLAND: Elective student, Dpt. of Clinical Immunology [Jul Aug 1994]. - UNIVERSITY OF ODENSE, DENMARK: Erasmus Program Student, Medical School and Language School [Aug Dec 1992]. - UNIVERSITY OF UTRECHT, HOLLAND: Summer Course "Medicine and National Health Systems" [Jul 1990].
Francisco Leon's Contact Information
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