Core Viewpoint - The completion of the pre-IND meeting with the FDA is a significant milestone for the clinical development of iTOL-102, a collaborative research initiative between iTolerance and Kadimastem aimed at treating Type 1 Diabetes [1][3][4]. Company Overview - Kadimastem is a clinical stage cell therapy company developing proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells [8]. - iTolerance is a regenerative medicine company focused on developing technologies for tissue, organoid, or cell therapy without requiring life-long immunosuppression [10]. Product Development - iTOL-102 is being evaluated as a potential breakthrough transplantation approach for Type 1 Diabetes, combining a tolerance-inducing agent with human stem cell-derived islets [2][4]. - iTOL-100, developed by iTolerance, is an immunomodulatory microgel technology designed to reduce or eliminate the need for chronic systemic immunosuppression after transplantation [5]. - Kadimastem's IsletRx consists of human pancreatic islet-like cells capable of secreting insulin, providing a scalable source of insulin-producing cells to address donor islet shortages [6][9]. FDA Interaction - Prior to the pre-IND meeting, Kadimastem and iTolerance received critical feedback from the FDA, which is essential for updating their plans for safety toxicology studies and preparing for a First-in-Human clinical trial [3][7]. - The feedback from the FDA is viewed as a validation of the companies' commitment to developing a transformative therapy for Type 1 Diabetes [7]. Market Potential - The collaboration between Kadimastem and iTolerance is seen as a potentially transformative step in diabetes treatment, with the aim of developing a potential cure for Type 1 Diabetes [4][7].
Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment