NewcelX Completes Type B Pre-IND Meeting With FDA; Administration Provided Constructive Feedback And Alignment On Proposed Strategy

The FDA provided clarity regarding the regulatory pathway toward launching a clinical trial of NCEL-101 for type 1 diabetes in combination with Eledon Pharmaceuticals’ (NASDAQ: ELDN ) anti-CD40L antibody, tegoprubart, an investigational immunomodulatory agent.

The meeting results represent a significant milestone toward the clinical development of an innovative treatment paradigm targeting a potential functional cure for type 1 diabetes.

The FDA provided favorable feedback on NewcelX's Chemistry, Manufacturing, and Controls ("CMC") processes and preclinical program allowing the Company to proceed toward its Investigational New Drug ("IND") enabling activities.

Combining NCEL-101, an enriched stem cell-derived islet product candidate, with Eledon’s anti-CD40L monoclonal antibody, tegoprubart, serving as the cornerstone of a calcineurin inhibitor-free immunosuppressive regimen is designed to enable durable graft survival and function, with the goals of achieving outcomes comparable to donor human islet transplantation.

This approach is supported by recently reported results from a 12-patient investigator-initiated study at University of Chicago Medicine in patients with 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 conducted under multiple FDA-cleared IND applications.

This body of clinical transplant experience provides important safety, dosing, and immunologic insights that are directly relevant to islet cell replacement therapies and support the planned advancement of NCEL-101.

NCEL-101, leveraging a differentiated enrichment process, has demonstrated favorable results in preclinical studies and a supportive safety profile with the following qualities: ~60% Beta cells co-express insulin and NKX6.1 MAFA expression, a transcription factor critical for Beta cell maturation and glucose-dependent insulin secretion 99.98% endocrine lineage, implying minimal, if any, off-target non-endocrine population More than 96% of cells are non-proliferative, as donor human islets