NLS Pharmaceutics and Kadimastem Submit FDA Pre-IND Meeting Request for Type 1 Diabetes Treatment

NLS Pharmaceutics and Kadimastem, two innovative companies in the biopharmaceutical field, have announced a significant move towards advancing diabetes treatment through a collaboration with iTolerance, a Miami-based regenerative medicine firm. On December 19, 2024, NLS Pharmaceutics, listed on Nasdaq as NLSP, and Kadimastem, a clinical-stage company from Israel, revealed that Kadimastem and iTolerance have filed a request for a Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) concerning iTOL102. This investigational biologic product combines allogeneic human stem cell-derived pancreatic islets with an immunomodulatory agent, aiming for a promising treatment for Type 1 Diabetes.

This submission follows a successful INTERACT meeting with the FDA earlier in the year, marking a pivotal milestone in the development of iTOL102. The collaborative effort between iTolerance and Kadimastem receives partial funding from the Israel-United States Binational Industrial Research and Development Foundation (BIRD). iTOL102 integrates iTolerance's proprietary SA-FasL microgel, an immune modulator, with IsletRx, insulin-producing islet cells derived from human pluripotent stem cells, promising a novel approach to potentially curing Type 1 Diabetes.

The SA-FasL microgel, known as iTOL-100, is an immunomodulatory technology developed to reduce the need for chronic systemic immunosuppression after transplanting allogeneic cells. According to iTolerance's preclinical studies using diabetic rodent models, iTOL-100 demonstrated compatibility with Kadimastem's IsletRx. IsletRx is a clinical-grade product comprised of human pancreatic islet-like cells capable of insulin secretion, representing a scalable source of insulin-producing cells that could alleviate the shortage of donor islets.

The iTOL102 product underwent evaluation at the Diabetes Research Institute (DRI) at the University of Miami School of Medicine. It was identified as a novel combination of an agent inducing immune tolerance and human stem cell-derived islets, showcasing functional insulin release and disease reversal in animal models.

Ronen Twito, Executive Chairman and CEO of Kadimastem, emphasized the importance of the Pre-IND meeting as a critical step in developing iTOL102, expressing excitement about this potential breakthrough therapy. Dr. Anthony Japour, CEO of iTolerance, highlighted the submission's significance, indicating their dedication to creating a diabetes cure using an allogeneic stem cell-derived pancreatic islet product, combined with iTOL-100, to minimize the need for life-long immunosuppression.

Meanwhile, Alexander Zwyer, CEO of NLS Pharmaceutics, expressed confidence in the pending merger with Kadimastem, which is anticipated to conclude by the end of January 2025. He believes this merger will substantially enhance the combined company's pipeline, providing valuable assets and a promising growth trajectory.

NLS Pharmaceutics and Kadimastem formalized their merger agreement in November 2024, subject to approval from their respective shareholders and other closing conditions. Founded in 2015 and headquartered in Switzerland, NLS Pharmaceutics is a development-stage biopharmaceutical company focusing on innovative therapies for rare and complex central nervous system disorders. Kadimastem, on the other hand, is a clinical-stage cell therapy company based in Israel, specializing in "off-the-shelf" allogeneic cell therapy products for neurodegenerative diseases and diabetes.

iTolerance is a privately-held company advancing regenerative medicine technologies to enable tissue, organoid, or cell therapy without requiring life-long immunosuppression. Its proprietary SA-FasL microgel platform technology is being utilized to develop therapies for Type 1 Diabetes, liver failure, and large organ transplants, demonstrating the potential to transform treatment paradigms for these conditions.