Eledon Reports Clinical Progress with Tegoprubart for Preventing Transplant Rejection

Eledon Pharmaceuticals, Inc., based in Irvine, California, announced the first participant in a clinical trial at the University of Chicago Medicine has received an islet cell transplant and is being treated with tegoprubart. This novel anti-CD40L antibody is being developed to prevent pancreatic islet cell transplant rejection in patients with type 1 diabetes. The trial, led by the University of Chicago Medicine’s Pancreatic and Islet Transplant Program, marks a significant milestone in this investigative therapy.

Additionally, Eledon shared updated data from their ongoing Phase 1b trial, which evaluates tegoprubart for preventing kidney transplant rejection. The findings demonstrated that tegoprubart successfully prevented rejection and was generally safe and well-tolerated among participants.

In January 2024, Eledon entered a collaboration with the University of Chicago Transplant Institute for an investigator-sponsored trial focusing on pancreatic islet cell transplantation in patients with type 1 diabetes. The trial incorporates tegoprubart as a key element of the immunosuppressive regimen. The study is funded by grants from the Juvenile Diabetes Research Foundation (JDRF) and the Cure Alliance.

Dr. Piotr Witkowski, Director of the Pancreatic and Islet Transplant Program at University of Chicago Medicine and principal investigator of the trial, emphasized the potential of islet cell transplantation to reverse diabetes by eliminating the need for external insulin and reinstating metabolic control. However, he noted that the toxicity of current standard anti-rejection medications, such as calcineurin inhibitors, has posed significant challenges. Tegoprubart aims to protect islets from rejection without these adverse effects.

Steven Perrin, President and Chief Scientific Officer of Eledon, highlighted the importance of this first islet cell transplant as part of the ongoing trial. He expressed optimism about the potential of tegoprubart to prevent transplant rejection, thereby improving the quality of life for individuals with type 1 diabetes. Perrin looks forward to further collaboration with the University of Chicago team to explore this potential.

The updated data from the Phase 1b trial as of April 2024 involved 13 participants and showed that tegoprubart is generally safe and well-tolerated. The results support the drug's potential to maintain organ function in kidney transplant patients, with all reported measures of kidney function, specifically estimated glomerular filtration rate (eGFR), remaining above 60 mL/min/1.73 m² after day 30. Two subjects who completed 12 months of therapy post-transplant exhibited mean eGFRs above 90 mL/min/1.73 m² at one year. Historically, standard immunosuppression therapies have reported average eGFRs in the low 50 mL/min/1.73 m² range during the first year after transplantation.

Three subjects discontinued the study due to hair loss and fatigue, viral infection, and rejection, respectively. However, there have been no cases of graft loss or death. Eledon plans to present these findings at the upcoming American Transplant Congress in Philadelphia, PA, in early June 2024.

Eledon is also conducting several other trials to evaluate tegoprubart for preventing organ rejection in kidney transplant patients. These include the Phase 1b trial (NCT05027906), the Phase 2 BESTOW trial (NCT05983770), and a Long-Term Safety and Efficacy extension study (NCT06126380).

Eledon Pharmaceuticals, Inc. focuses on developing immune-modulating therapies for managing and treating life-threatening conditions. Their lead investigational product, tegoprubart, targets the CD40 Ligand, a vital component in immune cell activation and function. This makes it an attractive candidate for immunomodulatory therapeutic intervention without depleting lymphocytes. The company's research spans preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS).