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Kadimastem and iTolerance Submit INTERACT Request with FDA for Potential Cure for Type 1 Diabetes

Kadimastem and iTolerance signed a collaboration agreement several months ago to co-develop cell technology as a potential cure for diabetes without the need for chronic immunosuppression and received a total grant of about US$1 million from the international BIRD fund.


The companies are examining the expansion of cooperation to advance product development.


 

Ness Ziona, Israel, November 7th 2023, Kadimastem Ltd. (TASE:KDST), a clinical stage cell therapy company developing a cell therapy treatment for ALS and a potential cure for diabetes and its diabetic product development partner, the American company iTolerance Inc., have asked the FDA for a preliminary meeting (INTERACT) regarding the companies’ joint diabetes treatment in development, iTOL-102, which does not require continuous suppression of the immune system.


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$1m (with a budget of about US$2 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. The parties intend to continue the development of the product and are even considering expanding the cooperation, for the benefit of product development, including through the establishment of a joint company in the United States.



IsletRx is comprised of clinical-grade clusters of human pancreatic islet like cells (ILCs) with the ability to secrete insulin. IsletRx cells can detect the sugar levels in the body and produce the required amounts of insulin and glucagon, iTolerance will provide its 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).


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.”


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.”


About Kadimastem

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.

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 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-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 by utilizing hepatocytes and iTOL-401 as a 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 or iTolerance’s control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the companies' activity, as well as developments in the general environment and external factors affecting the companies' activity. The companies’ results and achievements in the future may differ materially from any presented herein and the companies make no undertaking to update or revise such projection or estimate and do not undertake to update this document. This document does not constitute a proposal to purchase the companies' securities or an invitation to receive such offers. Investment in securities in general and in the companies in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future.


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Kadimastem Contacts:

Asaf Shiloni

CEO

For more information and/or a meeting with the company's management: Lior Gottlieb, lior@gotlive-ir.co.il, +972-50-9200194


iTolerance Contacts:

Investor Contact

Jenene Thomas Chief Executive Officer JTC Team, LLC

T: 833.475.8247

iTolerance@jtcir.com

Media Contact Susan Roberts

T: 202.779.0929

sr@roberts-communications.com

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