Kadimastem, in collaboration with iTolerance, has submitted a request to the FDA for a Pre-Investigational New Drug (Pre-IND) meeting regarding iTOL102, a novel biologic for treating Type 1 Diabetes. The therapy combines allogeneic human stem cell-derived pancreatic islets with an immunomodulator, potentially offering a curative approach for the disease.
The submission follows a successful INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products) meeting with the FDA earlier this year. The iTOL102 development is supported in part by the Israel-United States Binational Industrial Research and Development Foundation (BIRD).
iTOL102 consists of iTolerance’s SA-FasL microgel (iTOL-100), an immune modulator, and Kadimastem’s IsletRx, insulin-producing islet cells derived from human pluripotent stem cells. The combined approach aims to restore insulin production while minimizing the need for long-term immunosuppression.
IsletRx and iTOL-100: Components of iTOL102
Kadimastem's IsletRx is a clinical-grade product composed of human pancreatic islet-like cells capable of secreting insulin and glucagon. It represents a scalable source of insulin-producing cells, addressing the shortage of donor islets for transplantation. iTolerance's iTOL-100 is designed to reduce or eliminate the need for chronic systemic immunosuppression following allogeneic cell transplantation.
In preclinical studies using a diabetic rodent model, iTOL-100 demonstrated compatibility with Kadimastem’s IsletRx, suggesting a synergistic effect. iTOL102 was evaluated at the Diabetes Research Institute (DRI) at the University of Miami School of Medicine, where it was observed to induce functional insulin release and reverse disease in an animal model.
Executive Perspectives
Ronen Twito, Executive Chairman and CEO of Kadimastem, emphasized the importance of the Pre-IND meeting as a crucial step in bringing iTOL102 to market, stating, "We are committed to advancing our innovative IsletRx cell product and are excited about the potential of combining it with iTolerance’s immunomodulatory technology to create a potential cure for Type 1 diabetes."
iTolerance CEO Dr. Anthony Japour added that the FDA submission highlights their commitment to addressing the need for a diabetes cure with an off-the-shelf allogeneic stem cell-derived pancreatic islet product and iTOL-100, which may reduce the need for lifelong immunosuppression.
NLS Pharmaceutics Merger
Alexander Zwyer, CEO of NLS Pharmaceutics, anticipates that the pending merger with Kadimastem will add significant value to the combined company's pipeline. The merger is expected to close by the end of January, subject to shareholder approvals and other closing conditions.
