NCEL-101 + tegoprubart (AT-1501)

July 1, 2026: NewcelX Ltd. (NASDAQ: NCEL) reported successful completion of a Type B Pre-IND meeting with the FDA for NCEL-101, a stem cell–derived islet product candidate, to be developed for type 1 diabetes in combination with Eledon Pharmaceuticals’ (NASDAQ: ELDN) anti-CD40L antibody tegoprubart. The FDA provided constructive feedback and alignment on the proposed development strategy and regulatory pathway, including favorable feedback on Chemistry, Manufacturing, and Controls (CMC) and the preclinical program, enabling NewcelX to proceed toward IND-enabling activities and a planned clinical trial.

The release cites support for the combination strategy from a recently reported 12-patient investigator-initiated study at the University of Chicago Medicine in type 1 diabetes, where tegoprubart-based immunosuppression preserved transplanted islet function and maintained durable immune protection. Tegoprubart has been used as an investigational immunosuppressive agent in more than 100 transplant recipients across studies under multiple FDA-cleared INDs.

NewcelX also highlighted NCEL-101 preclinical/product characteristics (e.g., ~60% insulin/NKX6.1 co-expression; 99.98% endocrine lineage; >96% non-proliferative cells).