MIAMI, FL and NESS ZIONA, ISRAEL / November 7, 2023 / 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 and Kadimastem Ltd. (TASE:KDST) (“Kadimastem”), a clinical stage cell therapy company, today announced they have submitted a meeting request to the INTERACT committee of the U.S Food and Drug Administration (FDA) for iTOL-102, which is under development as a potential cure for Type 1 diabetes without the need for chronic immunosuppression.
This is the first of a three-step process, with the goal of designing and commencing an FDA-approved clinical study of iTOL-102. The second step would be to submit a pre-IND application based on the feedback from the INTERACT meeting, followed by an IND application to begin clinical trials at locations worldwide.
In May 2023, the companies announced their research collaboration agreement to co-develop and commercialize a breakthrough and innovative regenerative technology to cure diabetes without the need for chronic immunosuppression and received a grant in the aggregate amount of US$1 million from the Binational Israel-U.S. Industrial R&D (BIRD) Foundation. As part of the agreement, the companies are considering expanding their cooperation and advancing the development of iTOL-102 which combines Kadimastem’s advanced cell product for the treatment of diabetes called IsletRx, and iTolerance’s iTOL-100 immunomodulatory technology.
The purpose of the meeting would be to present the iTOL-102 development program and specifically discuss the chemistry, manufacturing and control (CMC) program, the definitive proof of concept study design in light of preliminary data, and general plans for non-clinical safety and clinical development.
Dr. Anthony Japour, Chief Executive Officer of iTolerance, commented, “We are pleased with the continued progress of our research collaboration with Kadimastem and look forward to meeting with the FDA. We believe that this collaboration has the potential to provide a much-needed, innovative cure for patients with Type 1 Diabetes and look forward to building on our continued momentum.”
Kadimastem Chief Executive Officer Asaf Shiloni added, “The INTERACT meeting is an important step forward for this development program. We are dedicated to advancing this program and providing diabetic patients with a potential solution to live without the need for insulin injections.”
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 Streptavidin-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-102, leverages 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 the treatment of liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com.
Kadimastem is a clinical stage cell therapy company, developing and manufacturing “off-the-shelf”, allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company’s lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications.
IsletRx is the company’s treatment for diabetes. IsletRx is comprised of functional, insulin and glucagon producing and releasing pancreatic islet cells, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, CSO of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).
This press release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995 and the Israeli Securities Law, 5728-1968. 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 current expectations and various assumptions of iTolerance and Kadimastem. The companies believe there is a reasonable basis for their expectations and beliefs, but they are inherently uncertain. The companies may not realize their expectations, and their 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 iTolerance’s platform technology. Consequently, forward-looking statements should be regarded solely as the companies’ current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The companies cannot guarantee future results, events, levels of activity, performance or achievements. The companies do not undertake and specifically decline 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.
Chief Executive Officer
JTC Team, LLC
SOURCE: iTolerance, Inc.
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