Kadimastem and iTolerance Complete Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) Meeting with the U.S. FDA
Ness Ziona, Israel, January 22, 2024, Kadimastem (TASE: KDST) and iTolerance Inc. announced today that the companies held a preliminary meeting with the INTERACT committee of the U.S Food and Drug Administration (FDA) on January 19th, 2024 regarding the preclinical and clinical development leading toward commercialization of iTOL-102, a potential cure for diabetes that does not require chronic immune system suppression.
Before the meeting, the companies received a response document from the FDA noting important feedback about the current preclinical plans which the companies intend to use for the advancement of their potential joint collaboration development plans. With the feedback from the INTERACT meeting received, the companies are working on the design and commencement of a clinical study of iTOL-102 that is planned to be submitted to the FDA for an IND in the future.
Dr. Anthony Japour, Chief Executive Officer of iTolerance, commented, “We are pleased with the continued progress of our research collaboration with Kadimastem. With the INTERACT meeting now complete and the feedback received from our discussions with FDA, we are evaluating next steps toward a potentially innovative cure for patients with Type 1 diabetes.”
Kadimastem CEO Asaf Shiloni said, " Thanks to our scientific teams who presented the joint collaboration project in an impressive manner. I am convinced that the helpful meeting and the relevant feedback will contribute to the continued progress of our planned joint product development and hopefully provide a cure for those living with diabetes.”
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$1.0 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.
The joint project is based on Kadimastem’s diabetes product called IsletRx, which is comprised of clinical-grade clusters of human pancreatic islet like cells (ILCs). Preclinical studies have shown that the cells are able to detect the sugar levels in the body and to produce and secrete dependently, the required amounts of insulin and glucagon, just like a healthy pancreas.
iTolerance, headquartered in Miami, Florida, has developed an innovative platform technology (iTOL-100) intended to enable the transplantation of allogeneic cells without tissue matching and without the need for chronic treatments that suppress the immune system of the transplant recipient (immunosuppression). This platform technology was successfully demonstrated in preclinical experiments in large animals (non-human primates), where diabetes was cured by allogeneic transplantation, without the need for long-term immunosuppressive treatments.
Kadimastem is a clinical stage cell therapy company, developing "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 pancreatic islet cells producing and releasing insulin and glucagon, 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).
About iTolerance, Inc.
iTolerance is an early-stage privately-held regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring 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. Utilizing iTOL-100 to induce local immune tolerance, the Company is developing its lead indication as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating 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.
Forward Looking Statement
This document may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under Kadimastem’s control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the company's activity, as well as developments in the general environment and external factors affecting the company's activity. The company's results and achievements in the future may differ materially from any presented herein and the company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the company's securities or an invitation to receive such offers. Investment in securities in general and in the company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future.
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Contact Details
Kadimastem
Asaf Shiloni CEO
iTolerance
Jenene Thomas Chief Executive Officer, JTC Team, LLC
+1 833-475-8247
Susan Roberts
+1 202-779-0929