Clinical-stage biotechnology company NewcelX Ltd. has announced a collaborative research agreement with immunology-focused firm Eledon Pharmaceuticals aimed at advancing potential new treatment strategies for Type 1 Diabetes.
The collaboration will explore combination approaches that integrate NewcelX’s lead cell therapy candidate NCEL-101 with Eledon’s investigational immune-modulating antibody Tegoprubart (AT-1501). The goal of the research partnership is to support long-term survival of transplanted insulin-producing cells while protecting them from immune rejection—an approach that could potentially move the field closer to a functional cure for Type 1 diabetes.
Type 1 diabetes occurs when the immune system mistakenly attacks insulin-producing beta cells in the pancreas, leaving patients dependent on lifelong insulin therapy. Cell replacement therapies that restore these insulin-producing cells have been a long-standing goal in diabetes research, but immune rejection and limited cell supply have posed significant challenges.
NewcelX’s NCEL-101 therapy is designed to address the shortage of insulin-producing cells by using stem-cell-derived islet cells that can be manufactured at scale and provided as an off-the-shelf product. However, maintaining the long-term survival of transplanted cells often requires strategies to control the immune response. The collaboration with Eledon is intended to address this issue by pairing the cell therapy with targeted immune modulation.
Tegoprubart, Eledon’s investigational antibody, targets the CD40 ligand (CD40L) pathway, which plays a key role in immune activation and transplant rejection driven by T cells. By blocking this pathway, the therapy aims to reduce immune-mediated damage to transplanted tissues.
Eledon has already gained experience with tegoprubart through studies involving more than 100 transplant patients, including individuals undergoing kidney, heart and diabetes-related transplant procedures. These studies were conducted under several Investigational New Drug applications cleared by the U.S. Food and Drug Administration. The clinical data from these transplant settings may help inform the development of NCEL-101 and could potentially help clarify the regulatory pathway for the therapy.
According to NewcelX’s Chief Scientific Officer Michel Revel, the partnership represents an important step in strengthening the company’s clinical development strategy while expanding collaboration with experts in immune biology and transplant medicine.
Company executives also indicated that combining targeted immune modulation with stem-cell-derived islet therapy could support durable graft survival comparable to outcomes observed with transplanted donor islets, which remain limited due to donor shortages.
Ronen Twito said the collaboration could help accelerate development timelines and provide clinically grounded insights that may lead to a more efficient regulatory pathway. He added that leveraging Eledon’s transplant experience could support a more disciplined development program for NCEL-101 while advancing the company toward key clinical milestones.
The companies believe the research collaboration could strengthen the prospects of stem-cell-based islet replacement therapies and contribute to ongoing efforts to develop long-term disease-modifying treatments for patients living with Type 1 diabetes.