iTolerance, Inc. Announces Formation of Scientific Advisory Board with Appointment of International Leaders in Immune Tolerance Discoveries

– Inaugural appointments include scientific founders of iTolerance’s regenerative cell therapy pipeline with expertise across biomaterials, immune modulators, and pancreatic islet transplantation for Type 1 Diabetes

– Company advances pioneering regenerative cell therapy pipeline with broad utility toward first-in-human study

– Lead product candidate, ITOL-101, for the treatment of Type 1 Diabetes entering IND-enabling studies

MIAMI, FL / ACCESSWIRE / September 13, 2021 / iTolerance, Inc. (“iTolerance” or the “Company”), a regenerative medicine company enabling tissue, organoid or cell therapy without the need for life-long immunosuppression, today announced the formation of its Scientific Advisory Board (“SAB”) and the appointment of its inaugural members, Andrés J. García, PhD, F.B.S.E., Haval Shirwan, PhD, and James Markmann, MD, PhD.

“As a patient first and data driven company, we are working to develop cures that better the lives of people living with chronic conditions. The independent and collaborative discoveries made by Drs. García and Shirwan, which are key components of the Company’s foundation, present the opportunity to potentially cure Type 1 Diabetes through pancreatic islet transplantation without lifelong immunosuppression. This work has been further confirmed in non-human primate studies in collaboration with Dr. Markmann, funded in part by the Juvenile Diabetes Research Foundation and the National Institute of Allergy and Infectious Diseases,” commented Dr. Anthony Japour, Chief Executive Officer of iTolerance. “The knowledge and expertise that each of these individuals bring in their respective fields are invaluable. We are pleased to leverage their continued guidance and expertise as we strive to cure human diseases of high unmet need including rare and ultra-rare diseases.”

About iTolerance’s Scientific Advisory Board Members:

Andrés J. García, PhD, F.B.S.E.

Dr. García is an internationally recognized leader in biomaterials, cellular and tissue engineering. He is the Parker H. Petit Chair and Executive Director of the Petit Institute for Bioengineering and Bioscience and is Regents’ Professor in Georgia Tech’s Woodruff School of Mechanical Engineering. Dr. García’s research program integrates innovative engineering, materials science, and cell biology concepts and technologies to create cell-instructive biomaterials for regenerative medicine and generate new knowledge in mechanobiology. This cross-disciplinary effort has resulted in new biomaterial platforms that elicit targeted cellular responses and tissue repair in various biomedical applications, innovative technologies to study and exploit cell adhesive interactions, and new mechanistic insights into the interplay of mechanics and cell biology.

Dr. García’s research has generated intellectual property and licensing agreements with start-up and multi-national companies. He has received several distinctions, including the NSF CAREER Award, Young Investigator Award from the Society for Biomaterials, Georgia Tech’s Outstanding Interdisciplinary Activities Award, the Clemson Award for Basic Science from the Society for Biomaterials, the International Award from the European Society for Biomaterials, and Georgia Tech’s Class of 1934 Distinguished Professor Award. He is an elected Fellow of Biomaterials Science and Engineering (by the International Union of Societies of Biomaterials Science and Engineering), Fellow of the American Association for the Advancement of Science, Fellow of the American Society of Mechanical Engineers, and Fellow of the American Institute for Medical and Biological Engineering. He is an elected member of the National Academy of Engineering and the National Academy of Inventors.

“iTolerance represents a significantly promising opportunity to translate scientific discovery into breakthrough innovations in regenerative medicine in Type 1 Diabetes and other chronic conditions. As one of the scientific founders, I’m honored to join the Scientific Advisory Board and leverage my personal expertise and insight in biomaterials as the Company advances these important development programs forward,” added Dr. Andres García.

Dr. Haval Shirwan stated, “Enabling cell therapy without the need for life-long immunosuppression with the Company’s biotechnology-derived fusion protein, iTOL-100, represents a catalytic shift in the current treatment paradigm. I’m thrilled to be a part of this team working together to bring potential cures to patients in dire need.”

Haval Shirwan, PhD

Dr. Shirwan is a pioneer in engineering cell and tissue surfaces with biologics for localized immunomodulation to induce tolerance. Dr. Shirwan currently serves as Professor of Child Health and Molecular Microbiology and Immunology, University of Missouri. He conducted his graduate studies at the University of California in Santa Barbara, CA, and postdoctoral studies at the California Institute of Technology in Pasadena, CA. Dr. Shirwan joined the University of Missouri, Columbia in 2020 after a long-term and productive professorship at the University of Louisville, Louisville, KY.

Dr. Shirwan’s translational research focuses on the regulation of immune system for the treatment of immune-based diseases. He pioneered the ProtEx™ technology with his collaborator Dr. Esma S. Yolcu as a facile and safe alternative to gene therapy for localized immunomodulation with applications to Type 1 Diabetes, transplantation, and cancer immunoprevention and immunotherapy. ProtEx™ allows the generation of novel ligands to immune pathways of interest and their transient and positional display on biological and nonbiological surfaces as a platform to alter undesired immune responses towards therapeutic outcomes. A manufactured protein immune ligand, known as Fas ligand (FasL), has shown efficacy in protecting the islet cells from destruction by the patient’s immune system. ProtEx™ is used to create FasL, which is then applied to islet cells to protect them from destruction by the immune system once they are transplanted into the patient. This technology is protected by 16 issued patents worldwide. Dr. Shirwan’s research has continuously been funded by federal, including NIH, and non-federal funding agencies. He is widely published with 2 books and 230 peer-reviewed papers, editorials, book chapters, and abstracts, and has organized and lectured at numerous national/international conferences. He is the Editor-in-Chief of OBM Transplantation, Review Editor for Frontiers in Immunology and Frontiers in Oncology, a member of several national and international societies, and recipient of various awards.

“There is no question that the data generated from the preclinical animal study support the advancement of iTOL-101 into human clinical studies. I am excited to continue our collaborative efforts to expand this opportunity and most importantly, provide much needed potential solutions to patients and physicians,” concluded Dr. James Markmann.

James Markmann, MD, PhD

Dr. Markmann is the Claude E. Welch Professor of Surgery at Harvard Medical School and the Chief of the Division of Transplant Surgery at Massachusetts General Hospital (MGH).

Dr. Markmann’s research in islet transplantation spans more than 30 years. During his career in Philadelphia, he helped to develop one of the first successful pancreatic islet transplant programs in the country. Upon arriving at MGH, his top priority was to develop a pancreatic islet program and in 2010, MGH performed the first islet transplant with islets prepared at MGH. Dr. Markmann currently leads the clinical allo- and auto islet programs at MGH and his research lab is investigating novel approaches to secure long-term islet survival including encapsulation and immune tolerance.

His clinical activity specializes in liver, kidney, pancreas, and islet transplantation as well as hemodialysis access surgery. His current research interests include understanding the mechanism of action and therapeutic potential of regulatory B cells; exploring the potential of ex vivo liver perfusion to improve marginal organ function; and clinical trials in transplantation tolerance and pancreatic islet transplantation. Dr. Markmann is active in numerous societies, editorial boards and organizations and is currently President of the International Pancreas and Islet Transplant Association and Treasurer of the American Society of Transplant Surgeons. He has published more than 400 scientific papers mostly in the area of immune tolerance and pancreas and islet transplantation and has held continuous NIH R01 funding for more than 20 years. He received his MD and PhD from the University of Pennsylvania School of Medicine and completed his residency in surgery at Pennsylvania School of Medicine in Philadelphia and his transplant surgery fellowship at Dumont-UCLA in California.

About ITOL-101

ITOL-101 is the Company’s lead program being developed as a potential cure for Type 1 Diabetes. iTolerance’s proprietary biotechnology-derived protein microgel platform, iTOL-100, acts to generate localized immune tolerance when allogenic pancreatic islets are implanted into the fat pad of the stomach (called the omentum). In a preclinical non-human primate study, implanted pancreatic islets when mixed with iTOL-100 have been shown to act similar to native pancreatic islets, secreting insulin in response to sugar intake¬ most importantly, study animals did not require long-term immunosuppressive therapy.

About iTolerance, Inc.

iTolerance is a privately held regenerative medicine company enabling tissue, organoid or cell therapy without the need for life-long immunosuppression. Leveraging our proprietary technology platform, iTOL-100, we are advancing a pipeline of programs using both allogenic pancreatic islets and stem-cells that have the potential to cure diseases. Our lead program, iTOL-101 is being developed for Type 1 Diabetes and in a preclinical non-human primate study, pancreatic islet cells co-transplanted with iTOL-100 exhibited long-term function with control of blood glucose levels and restoration of insulin secretion without the use of chronic immune suppression. Our follow-on candidate, iTOL-102 is leveraging significant advancements in stem cells, which allows a potentially inexhaustible supply of insulin-producing cells for use in Type 1 Diabetes. Additionally, the Company is developing iTOL-201 for liver failure and iTOL-301 as a potential regenerative protein and cell therapy that leverages stem cell sources to produce proteins or hormones in the body in conditions of high unmet need. For more information, please visit itolerance.com.

Investor Contact

Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
iTolerance@jtcir.com

SOURCE: iTolerance, Inc.

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