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NewCelX Ltd. Submits Pre-IND Package to the FDA for NCEL-101 for the Treatment of Type 1 Diabetes

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  • NewcelX Ltd. (NASDAQ: NCEL) submitted a Pre-IND briefing package to the FDA to advance its stem-cell-derived therapy NCEL-101 to a First-In-Human clinical trial.
  • The proposed trial combines NCEL-101 with tegoprubart, an investigational anti-CD40L monoclonal antibody developed by Eledon Pharmaceuticals (NASDAQ: ELDN).
  • This combination aims to create a calcineurin inhibitor-free immunosuppressive regimen designed to enable durable graft survival & function for a potential functional cure of type 1 diabetes.
  • The strategy is supported by recent results from a 12-patient investigator-initiated study at the University of Chicago Medicine showing tegoprubart preserved transplanted islet function & maintained durable immune protection.
  • Tegoprubart has been used in over 100 transplant recipients across multiple FDA-cleared Investigational New Drug applications, providing safety & dosing insights relevant to islet cell replacement therapies.
  • A Type B pre-IND meeting with the FDA is scheduled for the last week of June to discuss NCEL-101 manufacturing, preclinical development plans, & First-In-Human trial design.
  • NewcelX CEO Ronen Twito stated the meeting underscores the company's commitment to a potential cure for type 1 diabetes & noted the FDA's recent efforts to streamline the IND process for such innovations.
  • NewcelX utilizes a validated human pluripotent stem cell platform to develop scalable, off-the-shelf cell replacement therapies intended to restore functional insulin production.