NLS Pharmaceutics, Kadimastem submit request for FDA pre-IND meeting

NLS Pharmaceutics (NLSP) and Kadimastem, announced in collaboration with iTolerance, that a request for a Pre-Investigational New Drug meeting has been submitted by Kadimastem and iTolerance to the U.S. Food and Drug Administration for iTOL102, an investigational biologic consisting of allogenic human stem cell-derived pancreatic islets combined with an immunomodulator for the treatment of Type 1 Diabetes. This submission comes after an INTERACT meeting, which is a meeting at a specific time early in the product development, between Kadimastem, iTolerance, and the FDA earlier this year. The submission is a milestone toward the clinical development of iTOL102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by the Israel-United States Binational Industrial Research and Development Foundation. iTOL102 combines iTolerance’s proprietary SA-FasL microgel, an immune modulator, and IsletRx, insulin-producing islet cells derived from human pluripotent stem cells, to generate an treatment intended for the potential cure of type 1 diabetes. iTOL-100, an immunomodulatory microgel technology being developed by iTolerance is designed to reduce or eliminate the need for life-long chronic systemic immunosuppression following transplantation of allogenic cells. In a preclinical diabetic rodent model designed by iTolerance, iTOL-100 was shown by iTolerance to be compatible with Kadimastem’s IsletRx human stem cell-derived islets.