The collaboration will integrate NewcelX’s NCEL-101 with Eledon’s investigational anti-cluster of differentiation 40 ligand (anti-CD40L) monoclonal antibody, tegoprubart (AT-1501), to support durable, immune-protected islet replacement and develop a possible functional cure for T1D.
Tegoprubart is developed to regulate immune activation pathways critical to T-cell–mediated transplant rejection.
The partnership draws on clinical experience from more than 100 patients who have received tegoprubart across heart, kidney, and diabetes-related transplants, under multiple US Food and Drug Administration (FDA)-cleared investigational new drug (IND) applications.
This experience offers clinically informed insights and data pertinent to cell replacement therapies, which could help define a regulatory path for NCEL-101 and streamline development processes.
Combining targeted immune modulation with NCEL-101 is intended to promote durable graft survival, similar to outcomes observed with donor human islets.
NCEL-101 remains NewcelX’s primary therapeutic product, using scalable off-the-shelf manufacturing to address the shortage of functional insulin-producing cells.
The addition of immune modulation is intended to improve the durability and graft survival of transplanted cells.
The collaboration is expected to shorten development timelines, clarify regulatory requirements, and provide better visibility for advancing clinical milestones.
NewcelX executive chairman and CEO Ronen Twito said: “Collaborating with Eledon Pharmaceuticals represents a meaningful milestone for our product and a strategic step forward for NewcelX.
“Leveraging Eledon’s extensive transplant experience across more than 100 procedures provides us with clinically grounded insight that potentially supports a clearer regulatory pathway and a more efficient development plan for NCEL-101.
“Our focus is to translate this advantage into disciplined execution and long-term shareholder value.”