Kadimastem and iTolerance Submit Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) Meeting Request with FDA for Potential Cure for Type 1 Diabetes

–News Direct–

Kadimastem Ltd. (TASE:KDST), a clinical 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. The companies 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.

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 Kadimastems advanced cell product for the treatment of diabetes called IsletRx, and iTolerances iTOL-100 immunomodulatory technology.

From right to left: Dr. Kfir Molakandov, Asaf Shiloni, Anthony Japour, Prof. Michel Revel and Dr. Arik Hasson
From right to left: Dr. Kfir Molakandov, Asaf Shiloni, Anthony Japour, Prof. Michel Revel and Dr. Arik Hasson

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.

At Kadimastem we envision being a global leader in cell therapy.Our passion and commitment keep us moving forward, to develop innovative regenerative therapies for incurable diseases. Our goal is to treat millions of patients around the world with that technology.

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 Kadimastems or iTolerances 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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View source version on newsdirect.com: https://newsdirect.com/news/kadimastem-and-itolerance-submit-initial-targeted-engagement-for-regulatory-advice-on-cber-products-interact-meeting-request-with-fda-for-potential-cure-for-type-1-diabetes-290727328

Kadimastem Ltd.

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