NewcelX, Eledon to pair stem cell therapy with CD40 mAb against type 1 diabetes

Zurich-based NewcelX Ltd. (Nasdaq: NCEL) and Irvine, California-based Eledon Pharmaceuticals, Inc. (Nasdaq: ELDN) have entered a collaborative research agreement to evaluate a combination strategy pairing NewcelX’s NCEL-101, a stem cell derived islet therapy, with Eledon’s tegoprubart (AT-1501), an anti-CD40L monoclonal antibody designed to modulate T-cell-mediated immune activation. The aim is to evaluate the pairing as a durable, immune-protected islet replacement and potential functional cure for type 1 diabetes. No financial terms linked to the deal were disclosed.

The agreement is structured as a research collaboration rather than a traditional licensing arrangement. Eledon contributes clinical transplant data generated from over 100 patients treated with tegoprubart across kidney, heart, and diabetes-related transplant settings under multiple US FDA-cleared Investigational New Drug applications. NewcelX contributes NCEL-101, its lead program built on a human pluripotent stem cell platform and designed as a scalable, off-the-shelf cell replacement therapy intended to restore endogenous insulin production.

Deal context

NCEL-101 is a stem cell-derived islet cell therapy that aims to replace pancreatic β-cells destroyed by the autoimmune process underlying type 1 diabetes. Rather than targeting a single molecular pathway, the therapy delivers functional insulin-producing cells to restore glycemic control. Tegoprubart is a next-generation monoclonal antibody that binds CD40 ligand (CD40L/CD154), blocking its interaction with CD40 on antigen-presenting cells and thereby inhibiting downstream T-cell activation. Earlier-generation anti-CD40L antibodies were associated with thromboembolic complications; tegoprubart was designed to mitigate that risk. The rationale for the NewcelX collaboration is that pairing cell replacement with targeted immune modulation could promote durable islet graft survival without the broad immunosuppression typically required in transplant settings.

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NewcelX was formed through the October 2025 merger of NLS Pharmaceutics Ltd. (Switzerland) and Kadimastem Ltd. (Israel). The company’s pipeline is centered on cell therapy type 1 diabetes applications, with NCEL-101 as its lead asset.

The cell therapy type 1 diabetes space has attracted substantial deal activity. Vertex Pharmaceuticals acquired Semma Therapeutics in September 2019 for approximately USD 950 million to obtain stem cell-derived islet cell therapy technology that later advanced as VX-880. Vertex subsequently acquired ViaCyte in July 2022 for approximately USD 320 million, consolidating additional islet cell programs. In 2023, Novo Nordisk entered a partnership with Aspect Biosystems valued at up to approximately USD 725 million per bioprinted stem cell-derived islet cell therapy emerging from the partnership.

Of note, Lantidra (from CellTrans) is an allogeneic pancreatic islet cell therapy that received US FDA approval in 2023, becoming the first donor-derived islet cell transplant product approved for certain adults with type 1 diabetes. Also under development in the space is Vertex Pharmaceuticals’ zimislecel (formerly VX-880) — a stem cell-derived islet cell therapy in Phase I/II clinical development for type 1 diabetes