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NLS Pharmaceutics Highlights Continued Progress in iTOL-102 Diabetes Program as BIRD Foundation Approves Additional Milestone Payment to Kadimastem and iTolerance for Continued Co-Development of Type 1 Diabetes Cell Therapy
Prnewswire· 2025-07-17 11:00
Core Insights - The announcement highlights the successful completion of a Type B Pre-IND meeting with the FDA, allowing NLS and Kadimastem to advance towards First-in-Human clinical trials of iTOL-102 [1][3] - The BIRD Foundation has approved a milestone payment of approximately NIS 564,400 ($166,000 USD), increasing total support to nearly NIS 3 million ($882,352 USD) [2] - The collaboration between Kadimastem and iTolerance is seen as promising, with the potential of iTOL-102 to redefine treatment for Type 1 diabetes [3] Company Developments - Kadimastem is developing IsletRx technology, which is a scalable, stem cell-derived source of insulin-producing islet-like cells, combined with iTolerance's iTOL-100 platform in iTOL-102 [3] - NLS Pharmaceutics is preparing for safety toxicology studies and clinical trial submissions based on FDA guidance [4] - Dr. Eric Konofal from NLS has been recommended for the Prix Galien, recognizing his contributions to pediatric sleep medicine [5] Industry Context - iTolerance is focused on developing immunomodulatory technologies to enable transplantation without chronic systemic immunosuppression, with iTOL-102 as its lead program [8] - Kadimastem is a clinical-stage biotechnology company with a focus on allogeneic cell therapies, including potential treatments for Type 1 diabetes [6] - NLS Pharmaceutics is a development-stage biopharmaceutical company targeting rare and complex central nervous system disorders [9]