NewcelX Completes Type B Pre-IND Meeting With FDA; Administration Provided Constructive Feedback And Alignment On Proposed Strategy

The FDA provided clarity regarding the regulatory pathway toward launching a clinical trial of NCEL-101 for type 1 diabetes in combination with Eledon Pharmaceuticals’ (NASDAQ: ELDN ) anti-CD40L antibody, tegoprubart, an investigational immunomodulatory agent. The meeting results represent a significant milestone toward the clinical development of an innovative treatment paradigm targeting a potential functional cure for type 1 diabetes. The FDA provided favorable feedback on NewcelX's Chemistry, Manufacturing, and Controls ("CMC") processes and preclinical program allowing the Company to proceed toward its Investigational New Drug ("IND") enabling activities. Combining NCEL-101, an enriched stem cell-derived islet product candidate, with Eledon’s anti-CD40L monoclonal antibody, tegoprubart, serving as the cornerstone of a calcineurin inhibitor-free immunosuppressive regimen is design...