Project Grant R44DK148168

The National Institute of Diabetes and Digestive and Kidney Diseases awarded Gentibio, Inc. $1,066,332 on August 24, 2026, under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) to develop GNTI-148, an allogeneic islet-specific engineered regulatory T cell therapy for treating newly diagnosed type 1 diabetes.

GNTI-148 is designed to restore immune tolerance and preserve pancreatic islet function in newly diagnosed T1D patients with the goal of halting disease progression. The therapy builds on Gentibio's proprietary platform featuring stable FOXP3 expression, pancreatic islet-specific targeting, and tunable IL-2 signaling via a chemically inducible signaling complex. By integrating hypoimmune engineering technology, GNTI-148 can be delivered as an off-the-shelf allogeneic product, offering the durable efficacy of autologous therapies at lower cost and greater accessibility through allogeneic scalability.

Work is performed in Cambridge, Massachusetts. The period of performance runs through July 31, 2028. This is a Phase II SBIR award. The funding supports proof-of-concept, safety and toxicology, and technical development studies to validate GNTI-148 functionality, safety, and product feasibility.