ZURICH, Switzerland, March 9, 2026
NewcelX Ltd., a clinical-stage biotechnology company developing stem-cell-derived therapies for Type 1 Diabetes, has announced a strategic research collaboration with Eledon Pharmaceuticals aimed at advancing its lead therapeutic candidate NCEL-101. The collaboration integrates NewcelX’s stem-cell-derived pancreatic islet replacement therapy with Eledon’s investigational anti-CD40L monoclonal antibody tegoprubart (AT-1501) to support immune-protected islet cell transplantation and durable insulin production. Researchers believe that combining cell replacement technology with targeted immune modulation could potentially accelerate the development of a functional cure for Type 1 Diabetes, a chronic autoimmune disease affecting millions of people worldwide.
Strategic Collaboration to Advance Stem-Cell Therapy
The partnership between NewcelX and Eledon Pharmaceuticals focuses on developing combination treatment strategies designed to overcome one of the biggest barriers in cell therapy for diabetes—immune rejection. The collaboration will integrate NCEL-101, NewcelX’s stem-cell-derived islet replacement therapy, with tegoprubart, an investigational monoclonal antibody that targets immune activation pathways involved in transplant rejection.
Type 1 Diabetes occurs when the body’s immune system destroys insulin-producing beta cells in the pancreas, resulting in lifelong dependence on insulin therapy. While transplantation of donor pancreatic islets can restore insulin production, immune rejection and the limited availability of donor cells have historically limited widespread use of the therapy. NewcelX’s human pluripotent stem cell platform is designed to address this limitation by enabling scalable production of functional insulin-producing cells, offering the potential for an off-the-shelf therapeutic product capable of restoring glucose regulation in patients.
By combining advanced stem-cell technology with immune pathway modulation, the collaboration aims to protect transplanted cells from immune attack while maintaining long-term insulin production, potentially improving treatment durability and clinical outcomes for patients with Type 1 Diabetes.
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Immune Modulation Technology Supports Transplant Success
A key component of the collaboration involves Eledon’s investigational antibody tegoprubart (AT-1501), a next-generation therapy designed to block the CD40 ligand (CD40L) immune signaling pathway, which plays a central role in T-cell-mediated immune responses responsible for transplant rejection. By inhibiting this pathway, tegoprubart may help reduce immune activation and improve survival of transplanted therapeutic cells.
The therapy has already been evaluated in more than 100 transplant patients across multiple clinical settings, including kidney, heart, and diabetes-related transplant studies conducted under several U.S. Food and Drug Administration-cleared Investigational New Drug (IND) applications. These clinical experiences provide valuable translational insights into immune regulation and transplant biology, which could help accelerate the development pathway for NCEL-101.
Researchers believe that integrating immune-modulating biologic therapies with regenerative medicine approaches may significantly enhance the durability of cell-based treatments. If successful, the strategy could replicate or surpass outcomes achieved with donor-derived human islet transplantation, while offering a more scalable and accessible therapeutic solution.
Accelerating Development Toward a Functional Cure
The collaboration is expected to accelerate clinical development timelines and provide a clearer regulatory pathway for NCEL-101, supporting NewcelX’s long-term strategy of advancing transformative therapies for diabetes. By leveraging Eledon’s clinical experience in transplant immunology, the partnership aims to optimize trial design, streamline regulatory discussions, and improve overall development efficiency.
NCEL-101 remains NewcelX’s core therapeutic program, built on a human pluripotent stem cell platform designed to generate functional insulin-producing cells through scalable manufacturing technologies. The company’s integrated approach combines cell replacement therapy, immune protection strategies, and translational biomedical research to address the underlying causes of Type 1 Diabetes rather than simply managing symptoms.
Experts believe that innovations in regenerative medicine and immune modulation are rapidly transforming the landscape of diabetes treatment, opening new possibilities for therapies capable of restoring natural insulin production. Unlike traditional insulin injections, which require lifelong management, stem-cell-derived therapies could potentially restore metabolic function and reduce or eliminate dependence on daily insulin therapy.
With Type 1 Diabetes affecting millions of people globally and placing a significant burden on healthcare systems, the development of scalable cell therapies represents a promising step toward next-generation disease-modifying treatments. The collaboration between NewcelX and Eledon Pharmaceuticals therefore represents an important milestone in the advancement of precision regenerative medicine and immune-protected cell therapy strategies for chronic autoimmune diseases.
Source: NewcelX press release
