World-class leaders in the thymus, immunology, oncology, cell therapy, and drug development will inform and support the Company’s efforts to preserve, restore, and manipulate the thymus to address immune diseases

Pacific 8 Ventures joined the seed round syndicate led by Columbus Venture Partners, with participation by Criteria Bio Ventures, Sessa Capital, BioAdvance, and Ben Franklin Technology Partners

December 19, 2024 10:30 AM Eastern Standard Time

PHILADELPHIA–(BUSINESS WIRE)–Tolerance Bio, Inc., a biopharmaceutical company pioneering innovative approaches to increasing healthspan by preserving, restoring, and manipulating the function of the thymus, the master regulator of immune tolerance, today announced the formation of its Scientific Advisory Board (SAB) and the completion of its oversubscribed $20.2 million seed financing round.

Tolerance Bio is developing an allogeneic, or “off the shelf,” induced pluripotent stem cell (iPSC)-based thymus cell therapy platform as well as pharmacological thymus therapies to address immune-mediated diseases. These diseases are caused by abnormalities in immune tolerance, including cancer, autoimmunity, transplant rejection, infections, immune deficiencies, and allergies.

The Company announced the completion of its seed financing round with the addition of Pacific 8 Ventures to the previously announced syndicate led by Columbus Venture Partners, with participation from Criteria Bio Ventures, Sessa Capital, BioAdvance, Ben Franklin Technology Partners, and individual biotechnology investors.

To support the Company’s research and development (R&D) initiatives, Tolerance Bio also announced the formation of its Scientific Advisory Board (SAB).

“The Tolerance Bio team is humbled by the exceptional advisors and investors supporting our mission to preserve, restore and manipulate the thymus to address immune diseases and potentially increase longevity,” said Francisco Leon, M.D., Ph.D., Co-Founder and Chief Executive Officer of Tolerance Bio. “Each advisor is a leader in their respective fields, providing the Company with unbiased insights and guidance as we advance our programs in immunology, oncology, and beyond. We are incredibly excited by the opportunities lying ahead.”

Tolerance Bio’s SAB is comprised of the following members:

Dr. Holger Russ, Ph.D., is the Scientific Co-Founder of Tolerance Bio and its SAB Chairman. Dr. Russ is a pioneer in stem-cell derived thymic and beta cell generation. He is an Associate Professor in the Department of Pharmacology and Therapeutics at the Diabetes Institute of the University of Florida. He is also an Honorary Senior Research Fellow at the Institute of Metabolism & Systems Research at the University of Birmingham in the UK. Dr Russ’s research focuses on the generation of functional human thymic and pancreatic islets from pluripotent stem cells. He has made significant contributions to the field of regenerative medicine and is a co-inventor on eight patents in this area.

Dr. Megan Sykes, M.D., is the Michael J. Friedlander Professor of Medicine and Professor of Microbiology & Immunology and Surgical Sciences (in Surgery) at Columbia University. She is Director of the Columbia Center for Translational Immunology, Director of Research for the Transplant Initiative, and Director of Bone Marrow Transplantation Research at Columbia University Medical Center. Dr. Sykes has published more than 500 papers and book chapters during her research career, focusing on hematopoietic cell transplantation, organ allograft tolerance induction, xenotransplantation tolerance, and Type 1 diabetes. She has developed novel strategies for achieving GVL effects without GVHD following hematopoietic cell transplantation (HCT). One such approach provided safety and efficacy data in clinical trials of non-myeloablative haploidentical HCT that permitted the use of HCT for the intentional achievement of organ allograft tolerance in humans. Her work on xenogeneic thymic transplantation for tolerance induction has been extended into non-human primate and human studies. She has used mixed chimerism to reverse autoimmunity while replacing destroyed islets of Langerhans in Type 1 diabetes and developed novel “human immune system (HIS) mouse” models that allow personalized analysis of the pathogenesis of human immune disorders such as Type 1 diabetes. She has also used the HIS mouse model to understand human T cell repertoire development and assess the impact of stem cell-derived human thymic epithelial cells on human T cell development in a porcine thymus. Dr. Sykes is the Past President of the International Xenotransplantation Association, was President of the Federation of Clinical Immunology Societies (FOCiS) from 2022-2024, a recipient of the Medawar Prize, and a member of the National Academy of Medicine.

Dr. Camillo Ricordi, M.D., FNAI, is a Professor of Surgery, Distinguished Professor of Medicine, Professor of Biomedical Engineering, and Microbiology and Immunology at the University of Miami (UM), Florida, where he serves as Chief of the Division of Cellular Transplantation, Department of Surgery, Director of the Cell Transplant Center and Director Emeritus of the Diabetes Research Institute (DRI). Since 1993, he has been the Medical Director of the NIH-funded cGMP Advanced Human Cell and Biologic Product Manufacturing Facility, supporting global research and clinical applications. Dr. Ricordi is renowned for inventing groundbreaking technology to isolate islet cells from the human pancreas, revolutionizing islet transplantation for diabetes treatment. He led the first successful clinical islet allotransplants using purified donor islets, reversing diabetes through intra-hepatic infusion. This transformational procedure is now standard practice in clinical islet transplantation worldwide. In 1993, he joined the University of Miami to lead the DRI and Cell Transplant Center. Among his achievements, Dr. Ricordi led the first successful implantation of a bioengineered endocrine pancreas for patients with severe Type 1 Diabetes and chaired the NIH Phase 3 trial on islet transplantation. Currently, he serves as Chairperson of the International Steering Committee and Principal Investigator for two stem cell-derived islet transplant trials. A founding president of key professional organizations, Dr. Ricordi has received numerous accolades, including the World Prize in Surgery, the American Diabetes Association’s Outstanding Scientific Achievement Award, the Leonardo Da Vinci Award, and induction into the National Academy of Inventors. His extensive contributions include over 1,170 publications, 58,000 citations, 28 patents, and the bestselling book The Healthspan Code.

Dr. Jerome Ritz, M.D.’s research focuses on immune reconstitution after hematopoietic stem cell transplantation, cellular therapies, and cancer immunotherapy. Dr. Ritz has co-authored more than 450 scientific publications in peer-reviewed journals and contributed to numerous presentations at leading scientific conferences. From 1996 until June 2024, Dr. Ritz was Executive Director of the Connell and O’Reilly Families Cell Manipulation Core Facility (CMCF) at the Dana Farber Cancer Institute in Boston, Massachusetts. This GMP facility manufactures a variety of cellular products, including genetically modified hematopoietic stem cells, CAR T cells, NK cells, regulatory T cells, invariant NKT cells, and cancer vaccines for patients enrolled in early phase clinical trials. He is a Professor of Medicine at the Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and Harvard Medical School, and continues to lead a research team at the Dana-Farber Cancer Institute.

Dr. Manasi Jaiman, M.D., MPH,is the global, mission-driven Chief Medical Officer of Aardvark Therapeutics, and an expert on cell therapy clinical development. Dr. Jaiman advances breakthrough therapies through the integration of medicine and technology, drawing from 15 years of clinical development, device development, regulatory filings, direct patient care, and scientific research. She was the Chief Medical Officer of ViaCyte, a beta cell therapy company acquired by Vertex in 2022. Through her expertise in stem cell therapy disease and diabetes, she developed the world’s first-in-human protocol using gene-edited cells in a medical device for Type 1 diabetes and successfully executed the clinical trials. Dr. Jaiman also developed the first outpatient clinical trial to study a bi-hormonal artificial pancreas in adults and pediatrics at MassGeneral Hospital, then led clinical trials utilizing the bionic pancreas device, now used at Beta Bionics.

Dr. Roland Kolbeck, Ph.D., is co-owner and the Chief Scientific Officer of Spirovant and an expert on biologic therapeutics in immune diseases. Dr. Kolbeck is an accomplished biotech executive specializing in respiratory sciences and drug discovery. His career spans more than 20 years of research and executive leadership experience, including Vice President and Head of Respiratory, Inflammation, and Autoimmune research at MedImmune/AstraZeneca. At MedImmune, he led the development of FASENRA®, AstraZeneca’s first biological for the treatment of severe eosinophilic asthma, and contributed to the spinout of six pre/clinical-stage autoimmune assets. Previously, he held senior scientific roles at Peptimmune and Millennium Pharmaceuticals. Dr. Kolbeck also served as an Associate Professor in the Department of Pathology and Molecular Medicine at McMaster University from 2014-2022. He earned a PhD from the University of Regensburg and Max Planck Institute of Neurobiology, Munich.

About Tolerance Bio, Inc.

Tolerance Bio, Inc., is a biopharmaceutical company focused on manipulating immune tolerance via the thymus to address various immune-mediated diseases. The Company is based in Philadelphia, PA. For more information, visit www.tolerancebio.com or follow us on LinkedIn.

About Pacific 8 Ventures

Pacific 8 Ventures is a venture fund focusing at the nexus of new technology platforms and medicine. Pacific 8 Ventures typically backs transformative biotech and healthcare founders at the early stages. For more information, please visit: www.pac8.com

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