NCEL-101 + tegoprubart (AT-1501)

May 27, 2026: NewcelX Ltd. (NASDAQ: NCEL) submitted a Pre-IND briefing package to the FDA to support a proposed first-in-human clinical trial of NCEL-101, an enriched stem cell-derived islet product candidate, in combination with Eledon Pharmaceuticals’ (NASDAQ: ELDN) investigational anti-CD40L monoclonal antibody tegoprubart for type 1 diabetes. The companies plan to use tegoprubart as the core of a calcineurin inhibitor–free immunosuppressive regimen intended to enable durable graft survival and function.

A Type B pre-IND meeting with the FDA has been scheduled for the last week of June, where NewcelX expects to discuss NCEL-101 manufacturing, the preclinical safety/toxicology development plan, and the first-in-human trial design.

The release cites recently reported results from a 12-patient investigator-initiated study at the University of Chicago Medicine in type 1 diabetes in which tegoprubart-based immunosuppression preserved transplanted islet function and maintained durable immune protection, and notes tegoprubart has been used investigationally in more than 100 transplant recipients across multiple FDA-cleared INDs.