NewcelX, a clinical-stage company developing stem-cell-derived therapies for Type 1 Diabetes, has entered a collaborative research agreement with Eledon Pharmaceuticals, a clinical-stage immunology company specializing in transplant medicine.
The partnership aims to combine NewcelX’s lead program, NCEL-101, with Eledon’s investigational anti-CD40L monoclonal antibody, tegoprubart (AT-1501), to support durable, immune-protected islet replacement—paving the way toward a potential functional cure for Type 1 Diabetes.
Eledon’s tegoprubart, a next-generation therapy designed to modulate T-cell–mediated transplant rejection, has already been tested in over 100 transplant patients, including kidney, heart, and diabetes-related cases, under multiple FDA-cleared IND applications.
The collaboration will leverage this clinical experience to inform NCEL-101 development, streamline regulatory pathways, and potentially accelerate timelines for achieving durable graft survival comparable to donor human islets.
NCEL-101 remains NewcelX’s flagship therapy, tackling the shortage of functional insulin-producing cells through scalable, off-the-shelf manufacturing, with immune modulation intended to enhance graft survival.
Professor Michel Revel, CSO of NewcelX, said: "The collaboration marks an important strategic milestone for NewcelX, enhancing its execution-focused clinical programs and broadening collaboration with established leaders in immune biology and transplant medicine."
Ronen Twito, Executive Chairman & CEO of NewcelX, added: "Collaborating with Eledon Pharmaceuticals represents a meaningful milestone of 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."
The collaboration is expected to accelerate NCEL-101’s development, clarify regulatory pathways, and increase visibility for NewcelX’s clinical programs as the company advances toward pivotal milestones.