Sumitra Ghate promoted to Senior Vice President of Development & Global Regulatory Affairs to continue driving strategic regulatory and development programs
Dr. Esma S. Yolcu appointed as Chief Technical Scientist to advance development programs towards IND submissions
MIAMI, FL / September 7, 2022 / iTolerance, Inc. (“iTolerance” or the “Company”), an early-stage regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression, today announced the promotion of Sumitra Ghate to Senior Vice President of Development & Global Regulatory Affairs and the appointment of Esma S. Yolcu, PhD as Chief Technical Scientist.
“As we build momentum on multiple fronts, having the right people to lead our strategic initiatives remains a key component. Sumitra has proven to be an important asset to the team and with her extensive background in diabetes, cell therapies and regulatory affairs, she is uniquely qualified to help drive our strategic development and regulatory initiatives,” commented Dr. Anthony Japour, Chief Executive Officer of iTolerance. “Additionally, welcoming Dr. Esma Yolcu as our Chief Technical Scientist fills a crucial role to ensure the highest quality of research techniques for R&D and IND-enabling preclinical studies. Her expertise and intimate familiarity with our research conducted to date and the SA-FasL microgel technology as the co-inventor, provides an invaluable contribution to our team. Having such talented individuals with diverse skillsets further validates the potential of our technology and our mission to develop a potential cure for Type 1 Diabetes and other diseases.”
“With the addition of Dr. Yolcu’s expertise, we are advancing our CMC manufacturing to support research and development activities as well as preclinical and clinical studies. Her experience in the area of local immune tolerance and graft immune acceptance will be critical in the utilization and translation of our SA-FasL microgel technology from the academic setting to preclinical models as we advance toward the clinic,” stated Dr. Dennis Hester, Senior Vice President of Chemistry, Manufacturing & Controls.
Sumitra M. Ghate
Senior Vice President, Development & Global Regulatory Affairs
Ms. Ghate has served as the Vice President of Regulatory Affairs for iTolerance since October 2021. As the newly appointed Senior Vice President of Development & Global Regulatory Affairs, Ms. Ghate will be responsible for all aspects of iTolerance’s strategic regulatory and development programs including development and execution of pre-clinical programs to support candidate selection, IND-enabling studies, clinical development, as well as all regulatory interactions to advance toward commercialization.
“I am thrilled to continue my work as Senior Vice President of Development & Global Regulatory Affairs at iTolerance. I believe we have the potential to make a significant impact for the treatment of Type 1 Diabetes and beyond, and I look forward to continuing to build on the progress made to date,” added Ms. Ghate.
Ms. Ghate is an accomplished regulatory affairs leader with over twenty-five years of drug, biologic, and device development experience in the pharmaceutical and biotech industry. She has extensive expertise in developing and executing strong global regulatory strategies to minimize regulatory risk and accelerate development timelines. Over the course of her career, she has led the development and submission of over twenty INDs and three initial marketing applications, along with multiple marketing supplements.
Ms. Ghate received her BS in Organismal Biology and her BA in Chemistry from the University of Kansas. Additionally, she earned her US and EU Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.
Esma S. Yolcu, PhD
Chief Technical Scientist
Dr. Yolcu is an accomplished research scientist and medical professional concentrating in molecular biology, transplantation immunology, autoimmunity, and cancer immunology and immunotherapy with over 20 years of professional experience. Dr. Yolcu’s research focuses on the modulation of the immune system for the treatment of autoimmunity and graft rejection. Over the course of her career, her work has been funded by various federal and nonfederal funding agencies, including the National Institutes of Health, the American Heart Association, and the American Diabetes Association. Importantly, in relation to iTolerance, she is the co-inventor of the SA-FasL microgel technology and the co-author of the Company’s recently published Science Advances manuscript. Additionally, she personally oversaw the transplants in the non-human primate studies and has a wealth of experience on the technical aspects of the iTOL-100 immunomodulatory product.
“Having been closely aligned with the iTolerance team, I am pleased to expand my role with the Company. I remain committed to driving this important technology platform forward and believe it has the potential to address and area of significant unmet medical need. I look forward to continuing my work with the SA-FasL technology and help to advance the Company’s product candidates through preclinical development into clinical studies,” added Dr. Yolcu.
Dr. Yolcu is the recipient of several awards, is a member of various national and international societies, serves on Editorial Boards of scientific journals, and has published over 130 peer-reviewed papers, abstracts, and review articles in high-ranking journals, such as Immunity, Circulation, and Journal of Immunology. Dr. Yolcu currently serves as Professor in the Department of Child Health and Department of Molecular Microbiology and Immunology, School of Medicine at the University of Missouri, and the Gratis Professor, Department of Microbiology & Immunology, School of Medicine at the University of Louisville. She is a member of several medical associations including, the Institute of Clinical and Translational Sciences, Washington University, American Society of Hematology, American Diabetes Association, American Society of Transplantation, and The Transplantation Society.
Dr. Yolcu received her BSc in Biology from Ankara University. In addition, she received a MSc in Medical Biology and Genetics from the School of Medicine at Gazi University. She continued her education and earned her PhD in Biology and Genetics from Ankara University and post-doctoral fellowship training from University of Louisville, Kentucky, USA.
About iTolerance, Inc.
iTolerance is an early-stage privately held regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression. Leveraging its proprietary biotechnology-derived Strepavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic pancreatic islets and stem cells that have the potential to cure diseases. The Company’s lead program, iTOL-101 is being developed for Type 1 Diabetes and in a pre-clinical non-human primate study, pancreatic islet cells co-implanted with iTOL-101 exhibited long-term function with control of blood glucose levels and restoration of insulin secretion without the use of chronic immune suppression. The Company’s second lead candidate, iTOL-102, is leveraging significant advancements in stem cells to derive pancreatic islets which allows an inexhaustible supply of insulin-producing cells. Utilizing iTOL-100 to induce local immune tolerance, iTOL-102 has the potential to be a cure for Type 1 Diabetes without the need for life-long immunosuppression. 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 without the need for life-long immunosuppression. For more information, please visit itolerance.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.
All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company’s platform technology. Consequently, forward-looking statements should be regarded solely as the Company’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
Investor Contact
Jenene Thomas
JTC Team, LLC
T: 833.475.8247
iTolerance@jtcir.com
Media Contact
Susan Roberts
T: 202.779.0929
sr@roberts-communications.com
SOURCE: iTolerance, Inc.
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