Sernova Biotherapeutics (SEOVF) announced a Collaborative Research Agreement with Eledon Pharmaceuticals (ELDN) to evaluate Eledon’s immunosuppressive agent tegoprubart in Sernova’s ongoing Phase 1/2 clinical trial of its Cell Pouch Bio-hybrid Organ in patients with type 1 diabetes. Under the terms of the agreement, Eledon will supply tegoprubart, an investigational anti-CD40L antibody being evaluated for its potential to prevent transplant rejection in islet cell, kidney and xeno transplantation, will be used in place of tacrolimus in the upcoming Cohort C of Sernova’s Phase 1/2 clinical trial. Tacrolimus is currently a standard immunosuppressive drug used in organ transplantation to prevent rejection. However, its potential toxicity, particularly toward insulin-producing beta cells, and its side effect profile limit its suitability as an optimal immunosuppressive agent for islet cell therapy in T1D. In an investigator-initiated study led by Dr. Piotr Witkowski, a leading expert in islet transplantation at the University of Chicago, T1D patients received islet transplants along with tegoprubart to prevent rejection. Three participants achieved normal, stable blood sugar levels and became insulin independent. Islet engraftment, measured by graft function standardized to the number of islets infused, was three to five times higher than in comparable subjects outside this study who received tacrolimus-based immunosuppression, suggesting treatment with tegoprubart better protects transplanted islets resulting in improved graft survival and function. Treatment was generally well tolerated in all subjects with no unexpected adverse events or severe hypoglycemic episodes.
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