NewcelX Ltd. (NASDAQ:NCEL), a regenerative medicine company, on Wednesday announced the submission of a Pre-IND briefing package to the U.S. Food and Drug Administration (FDA) for NCEL-101.

NCEL-101 is the company's flagship stem cell-derived islet replacement therapy, designed as a scalable, "off-the-shelf" treatment to restore functional insulin production in patients with Type 1 Diabetes.

The submission supports a proposed First-In-Human clinical trial for the company's type 1 diabetes treatment program.

"The Pre-IND meeting for NCEL-101 is a pivotal milestone that underscores our commitment towards a potential cure for T1D," said Ronen Twito, Executive Chairman and CEO of NewcelX.

FDA Submission And Trial Plans

NewcelX submitted the Pre-IND package to support a proposed First-In-Human clinical trial evaluating NCEL-101 in combination with Eledon Pharmaceuticals' (NASDAQ:ELDN) investigational immunomodulatory agent tegoprubart for the treatment of type 1 diabetes.

The company paired NCEL-101, an enriched stem cell-derived islet product candidate, with investigational anti-CD40L monoclonal antibody tegoprubart.

The regimen aims to support durable graft survival and function without using calcineurin inhibitor-based immunosuppression.

The FDA scheduled a Type B pre-IND meeting for the last week of June. During the meeting, NewcelX plans to discuss NCEL-101 manufacturing, preclinical safety and toxicology studies, and the design of the proposed First-In-Human trial.

Clinical Support For Combination Approach

NewcelX cited data from a 12-patient investigator-initiated study at the University of Chicago Medicine in type 1 diabetes patients.

The study showed tegoprubart-based immunosuppression preserved transplanted islet function and maintained durable immune protection.

The company said tegoprubart has served as an investigational immunosuppressive agent in more than 100 transplant recipients.

Researchers evaluated the therapy across studies conducted under multiple FDA-cleared Investigational New Drug applications.

The studies provided safety, dosing and immunologic insights relevant to islet cell replacement therapies.

NewcelX develops stem-cell-derived therapies for type 1 diabetes using a human pluripotent stem cell platform. Its lead program, NCEL-101, aims to restore insulin production through scalable, off-the-shelf cell replacement therapy.

NCEL Price Action: NewcelX shares were up 9.84% at $3.46 during premarket trading on Wednesday, according to Benzinga Pro data.

Photo via Shutterstock