University of Miami's Diabetes Research Institute Announces Breakthrough in Type 1 Diabetes Treatment

Kadimastem Ltd. (TASE: KDST) has announced positive results for its innovative diabetes treatment developed in collaboration with iTolerance Inc. The promising findings were presented at the 84th scientific conference of the American Diabetes Association (ADA) in a late-breaking session. This breakthrough treatment, evaluated at the Diabetes Research Institute (DRI) at the University of Miami, demonstrates significant potential in reversing Type 1 Diabetes (T1D) without the need for chronic immune suppression.

The DRI, a world-renowned diabetes research institute, highlighted the treatment's effectiveness in a model of diabetes. The treatment combines an immune modulator microgel material with insulin-producing islet cells derived from human stem cells. The microgel material, developed by iTolerance, eliminates the need for systemic immune suppression, while Kadimastem's stem cell-derived islet cells produce and release insulin.

Experts at DRI presented data showcasing the compatibility, safety, and efficacy of the treatment. The combination of iTolerance's iTOL-100 microgel material and Kadimastem's IsletRx pancreatic cells successfully restored glycemic balance in a diabetes animal model. Dr. Giacomo Lanzoni, a program leader at the DRI, emphasized the transformative potential of this approach, noting that it could offer a scalable and sustainable solution for T1D.

Dr. Camillo Ricordi, Director of the Cell Transplant Center at DRI, commented on the importance of the Fast Track Center for Testing at the DRI Cell Transplant Center in validating emerging technologies. Dr. Ricordi expressed hope that this innovative treatment could one day replace the limited availability of pancreas-derived islets from multiorgan donors and eliminate the need for life-long recipient immunosuppression.

The study's key findings indicate that the combination therapy not only reverses diabetes but also preserves the functional integrity of the transplanted stem cell-derived islets. Key highlights of the study include:

- IsletRx, developed by Kadimastem, is a scalable and virtually unlimited source of insulin-producing cells, addressing the critical shortage of donor islets for transplantation.

- iTOL-100, developed by iTolerance, is an immunomodulatory microgel designed to eliminate the need for chronic systemic immunosuppression. It induces local immune acceptance of transplanted islets and is compatible with stem cell-derived islets.

- The transplantation procedure is performed in a retrievable site, allowing for minimally invasive graft retrieval if needed.

- The study reports successful reversal of diabetes in a chemically induced model, with no observed toxicity from the microgel.

Prof. Michel Revel, Chief Scientist of Kadimastem, highlighted the collaboration with iTolerance as a world-first avenue for transplanting pancreatic islet cells without the need for full immune suppression. Prof. Revel emphasized the high quality of Kadimastem's pancreatic islet cells and the potential of this combined approach to prevent implant rejection. The joint project has successfully completed an Interact meeting with the FDA, and both companies are moving towards the pre-IND submission stage.

Dr. Anthony Japour, CEO of iTolerance, expressed his excitement about co-sponsoring the project at the DRI. He noted that removing the need for life-long toxic immunosuppressive agents in islet transplantation is a common goal for those working towards a cure for T1D.

Kadimastem is a clinical-stage cell therapy company developing allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. iTolerance is an early-stage regenerative medicine company developing technologies to enable tissue, organoid, or cell therapy without requiring life-long immunosuppression.

The Diabetes Research Institute at the University of Miami Miller School of Medicine is committed to developing innovative strategies to restore natural insulin production and normalize blood sugar levels without imposing other risks.

For more information, please visit Kadimastem and iTolerance.