The World Prestigious Diabetes Research Institute, University of Miami, Announces Kadimastem's Joint Project as Breakthrough Transplantation Approach for the Treatment of Type 1 Diabetes

June 23, 2024 at 07:00 AM EDT

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Kadimastem Ltd. (TASE: KDST), announces positive results of its leading diabetes product jointly developed with iTolerance Inc. The results were presented at the 84th scientific conference of the American Diabetes Association (ADA), in a late-breaking session. The product was evaluated by at the DRI, The Fast Track Center for Testing at the DRI Cell Transplant Center where it was designated to be a “novel combination of tolerance-inducing agent and human stem cell-derived islets demonstrates functional insulin release and disease reversal in a model of diabetes.” Link to quote.

The recognition of the scientific progress of the treatment, which combines immune modulator microgel material (a substance that eliminates the need for chronic systemic immune suppression) and insulin-producing islet cells derived from human stem cells, as an innovative treatment intended for the treatment of type 1 diabetes, was given by the world's largest diabetes research institute at the University of Miami (Florida) School of Medicine (DRI).

The experts at DRI presented product compatibility, safety and efficacy to the conference attendees, concluding that combination of the engineered iTOL-100 microgel material developed by iTolerance and the pancreatic cells - IsletRx developed by Kadimastem - can effectively restore normoglycemia (a state of glycemic balance like that of a healthy person) in a diabetes animal model.

CEO of iTolerance Inc. Anthony Japour M.D., Executive Chairman of the Board of Kadimastem Ltd., Ronen Twito & Principal Investigator at iTolerance, Dr. Giacomo Lanzoni

Dr. Giacomo Lanzoni, PhD, program leader at the DRI, stated, "Our observations highlight the transformative potential of combining stem cell-derived islets with an immunomodulatory microgel. This approach could enable transplantation across the allogeneic barrier, offering a scalable and sustainable solution for T1D, and could enhance the safety and long-term efficacy of islet cell transplantation.”

Dr. Camillo Ricordi, MD, Director of the Cell Transplant Center and Director Emeritus at the Diabetes Research Institute, commented: “The Fast Track Center for Testing at the DRI Cell Transplant Center continues to serve as a key shared resource to validate emerging technologies towards a cure for diabetes. We hope to continue to be of assistance towards the identification of reliable and potentially unlimited stem cell-derived islet sources for transplantation, which may one day be able to replace the limited availability of pancreas-derived islets from multiorgan donors, when life-long recipient immunosuppression will no longer be required.”

The study's key findings indicate that this combination therapy reverses diabetes and preserves the functional integrity of the transplanted stem cell-derived islets.

Key Highlights:

-IsletRx, a preparation of Human Stem Cell-Derived Islets developed by Kadimastem, Ltd., is a scalable and virtually unlimited source of insulin-producing cells, and could address the critical shortage of donor islets for transplantation.

-iTOL-100, an immunomodulatory microgel developed by iTolerance, Inc., designed to eliminate the need for chronic systemic immunosuppression and shown to induce local immune acceptance of transplanted islets, was found to be compatible with stem cell-derived islets.

-Implantation in a Retrievable Site: The transplantation procedure is performed in a retrievable site, ensuring the possibility of graft retrieval through a minimally invasive surgery, if needed.

-Successful Reversal of Diabetes: The study reports reversal of disease in a chemically induced model of diabetes, with comparable efficacy of IsletRx in the presence or absence of iTOL-100, indicating a lack of toxicity from the microgel.

Additional Comments:

Prof. Michel Revel, Chief Scientist of Kadimastem: "Our collaboration with iTolerance opens an innovative and world-first avenue for transplanting pancreatic island cells into diabetics without the need for full suppression of the immune system, which is required today in organ transplants. Prof. Revel emphasized, "Our company produces high-quality pancreatic islet cells. The joint data collected by us prove the possibility of combining our cells with the material that locally prevents the rejection of the implant developed by our project partner iTolerance. The successfully completed an Interact meeting with the FDA, and the two companies are moving together to the pre-IND submission stage."

Dr. Anthony Japour, CEO of iTolerance, Inc., commented, “iTolerance is pleased to co-sponsor the project at the Diabetes Research Institute toward a functional cure of T1D through the combination of human stem cell-derived insulin producing islet cells together with our iTOL-100 proprietary immunomodulator. Removing the need for life-long toxic immunosuppressive agents in islet transplantation is a common goal among those working toward a cure for T1D through transplantation without immunosuppression.”

About Kadimastem

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®, 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).

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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.

About the Diabetes Research Institute (DRI)

The Diabetes Research Institute at the University of Miami Miller School of Medicine is a recognized world leader in cure-focused research. The DRI is committed to developing and rapidly applying innovative strategies to restore natural insulin production and normalize blood sugar levels without imposing other risks.

For more information, please visit https://diabetesresearch.org/

Kadimastem (TASE:KDST) is a clinical stage biotechnology company, with a unique platform for cell therapy that enables the production of off-the-shelf cell-based products for the treatment of unmet medical needs. Kadimastem was founded in 2009 based on patent protected technology that was developed at Prof. Michel Revel’s laboratory at the Weizmann Institute of Science.

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