U.S. biotechnology firm Eledon Pharmaceuticals has filed an Investigational New Drug application with the FDA to initiate a registration clinical trial evaluating its anti-CD40L antibody tegoprubart in pancreatic islet cell transplantation for type 1 diabetes patients.
The trial will assess tegoprubart as part of an immunosuppression regimen without calcineurin inhibitors, a standard component in post-transplant care. Eledon’s submission follows early-stage studies at the University of Chicago Medicine Transplant Institute, where 12 patients with type 1 diabetes and chronic kidney disease-related renal dysfunction received islet cell transplants and tegoprubart-based therapy. All 12 patients achieved insulin independence with hemoglobin A1c levels below 7.0%, and stable islet graft function was maintained for up to 22 months in the longest follow-up period reported.
The ongoing investigator-initiated study at the University of Chicago is expanding enrollment, adding three new patients beyond the initial cohort. Separately, compassionate use protocols have administered tegoprubart to additional patients. A type 1 diabetes patient received the therapy to replace tacrolimus-based immunosuppression due to calcineurin inhibitor-related renal dysfunction. At Duke University Medical Center, a highly sensitized patient undergoing renal transplantation received tegoprubart under a compassionate use protocol, while a third patient was treated in an investigator-initiated study at Massachusetts General Hospital evaluating the drug for tolerance induction in kidney transplantation.
Eledon remains on track to launch its global Phase 3 LEGACY trial of tegoprubart in kidney transplantation in the fourth quarter of 2026, with enrollment expected to include approximately 600 patients.
