NewcelX, Eledon Partner to Advance a Potential Functional Cure for Type 1 Diabetes

NewcelX Ltd., a clinical-stage company, has entered a strategic collaboration with Eledon Pharmaceuticals Inc., a clinical-stage immunology company, to advance combination strategies integrating NewcelX’s lead program, NCEL-101, with Eledon’s investigational anti-CD40L monoclonal antibody, tegoprubart (AT-1501), with the goal of supporting durable, immune-protected islet replacement and advancing a potential functional cure for Type 1 Diabetes.

Eledon’s tegoprubart is a next-generation anti-CD40L monoclonal antibody designed to modulate immune activation pathways central to T-cell–mediated transplant rejection. The collaboration leverages clinical experience from over 100 transplant patients treated with tegoprubart, including patients in kidney, heart and diabetes-related transplant settings, developed under multiple U.S. Food and Drug Administration–cleared Investigational New Drug (IND) applications. This transplant experience provides clinically informed insights and data relevant to cell replacement therapies, and could potentially lead to a clearer regulatory pathway for NCEL-101 while streamlining the development program. Integrating targeted immune modulation with NCEL-101 is intended to support durable graft survival comparable to outcomes observed with donor human islets.

Professor Michel Revel, MD, PhD, CSO of NewcelX, said, “The collaboration marks an important strategic milestone for NewcelX, enhancing its execution-focused clinical programs and broadening collaboration with established leaders in immune biology and transplant medicine.”

The companies expect the collaboration to accelerate timelines, establish a well-defined regulatory pathway, and enhance development visibility, supporting NewcelX’s strategy to advance its clinical programs efficiently toward pivotal milestones.