BOSTON, Jan. 26, 2026—GentiBio, Inc., a biotechnology company pioneering engineered regulatory T cell (EngTreg) therapies, today announced that Breakthrough T1D, with support in part from The Leona M. and Harry B. Helmsley Charitable Trust, has awarded a grant to support the company’s POLARIS clinical trial evaluating GNTI‑122, an autologous EngTreg investigational therapy designed to preserve endogenous insulin production and provide a potential cure for type 1 diabetes (T1D).
The collaborative grant will support the clinical development of GNTI-122 through the POLARIS study, in adults recently diagnosed with T1D and advance GentiBio’s mission to deliver disease-modifying therapies that address the underlying autoimmune drivers of the disease.
“This grant reflects the community’s confidence in the promise of EngTregs to change the trajectory of T1D. With the support of Breakthrough T1D and Helmsley, we are accelerating our efforts to bring GNTI‑122 to patients at a critical window, where preserving natural insulin production may have profound, long-term benefits. We are confident that this partnership will help us advance our goal of transforming care with therapies that address the root causes of autoimmunity and offer hope for a cure,” said Andy Walker CEO of GentiBio.
“As the first clinical assessment of engineered, antigen-specific Tregs for type 1 diabetes, the POLARIS trial represents an important step forward for the field,” said Josh Vieth, Ph.D., Senior Director of Research at Breakthrough T1D. “Advancing therapies that can change the course of type 1 diabetes for those living with the condition is a key priority for Breakthrough T1D, and we are excited to work with GentiBio, a T1D Fund portfolio company, and the Helmsley Charitable Trust in support of this important research. We look forward to the potential of these therapies for preserving beta cell function by rebalancing the immune system.”
“GNTI‑122 is an innovative and promising targeted therapy to delay the progression of T1D,” said Dr. Maryaline Coffre, Program Officer at the Helmsley Charitable Trust. “Our support for this initiative exemplifies our unwavering commitment to improving the lives of people with T1D.”
About GNTI‑122 and EngTreg Therapy
GNTI‑122 is a novel targeted autologous engineered regulatory T cell therapy (EngTreg) designed to restore immune tolerance and preserve pancreatic islet function by suppressing autoreactive effector T cells that drive disease. GentiBio’s EngTreg platform delivers targeted, durable immunomodulation aimed at curing autoimmune and inflammatory diseases.
About the POLARIS Study
POLARIS (NCT06919354) is a Phase 1, open‑label, single‑dose clinical trial enrolling adults aged 18–45 years within 120 days of T1D diagnosis. Participants are assigned to sequential cohorts that evaluate dose levels of GNTI‑122 and may include combination with low‑dose rapamycin. The study assesses safety, tolerability, pharmacodynamic activity, and biomarker responses—including C‑peptide, insulin use, hemoglobin A1c, immunophenotyping, and vector‑based tracking of cell persistence—through 78 weeks of follow‑up. For more information, visit polarisstudy.com or ClinicalTrials.gov (NCT06919354).
About GentiBio
GentiBio is a biotechnology company developing engineered regulatory T cell (EngTreg) therapies to restore immune tolerance and transform the treatment of autoimmune and inflammatory diseases. By harnessing the natural power of Tregs and engineering them for precision, durability, and scalable manufacture, GentiBio seeks to deliver curative therapies for patients with significant unmet need. Learn more at gentibio.com.
About Breakthrough T1D
As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition.
About the Helmsley Charitable Trust
The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning active grantmaking in 2008, Helmsley has granted more than $4.6 billion for a wide range of charitable purposes. The Helmsley Type 1 Diabetes (T1D) Program is the largest private foundation funder in the world with a focus on T1D, with more than $1 billion to date committed to transform the trajectory of the disease and to accelerate access to 21st century care, everywhere. For more information on Helmsley and its programs, visit helmsleytrust.org.
