Clinical TrialMay 27, 2026, 08:02 AM
NewcelX Submits Pre-IND Package to FDA for NCEL-101 for Type 1 Diabetes
AI Summary
NewcelX Ltd. announced the submission of a Pre-Investigational New Drug (Pre-IND) briefing package to the FDA for NCEL-101, its stem cell-derived islet product candidate. This submission aims to support a First-In-Human clinical trial for the treatment of Type 1 Diabetes, utilizing NCEL-101 in combination with Eledon Pharmaceuticals' tegoprubart. A Pre-IND meeting with the FDA is scheduled for the last week of June to discuss manufacturing, preclinical plans, and trial design, marking a significant step towards a potential functional cure for the disease.
Key Highlights
- NewcelX submitted a Pre-IND package to the FDA for NCEL-101 for Type 1 Diabetes.
- NCEL-101 is an enriched stem cell-derived islet product candidate.
- The treatment combines NCEL-101 with Eledon's investigational immunomodulatory agent, tegoprubart.
- A Pre-IND meeting with the FDA is scheduled for the last week of June.
- The meeting will discuss NCEL-101 manufacturing, preclinical plan, and FIH clinical trial design.
- The submission is a significant milestone towards a potential functional cure for type 1 diabetes.
- Tegoprubart has been used as an immunosuppressive agent in over 100 transplant recipients.
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