Presentation highlights favorable safety and tolerability profile and continued progress of the ongoing POLARIS Phase 1 study
Cambridge, Mass., October 6, 2026 – GentiBio, Inc., a clinical-stage biotechnology company pioneering engineered regulatory T cell (EngTreg) therapies, today announced that new data from its ongoing Phase 1 POLARIS clinical trial evaluating GNTI-122 in adults with recently diagnosed type 1 diabetes (T1D) will be presented at the Breakthrough T1D Clinical Research Conference (CRC) 2026 in Philadelphia, Pennsylvania.
The presentation, titled “Early Clinical Evaluation of GNTI-122, an Engineered Regulatory T Cell Therapy, in Recent-Onset Type 1 Diabetes,” will be delivered by Mark Bach, M.D., Ph.D., Chief Medical Officer of GentiBio.
Presentation Details
Title: Early Clinical Evaluation of GNTI-122, an Engineered Regulatory T Cell Therapy, in Recent-Onset Type 1 Diabetes
Presenter: Mark Bach, M.D., Ph.D., Chief Medical Officer, GentiBio
Session: Disease Modifying Therapies
Date/Time: Sun, 10/11/26, 10:40 AM – 11:00 AM
Location: Breakthrough T1D Clinical Research Conference 2026, Philadelphia, Pennsylvania
“We are encouraged by the progress of the POLARIS study and pleased to share this early update with the type 1 diabetes research community,” said Mark Bach, M.D., Ph.D., Chief Medical Officer of GentiBio. “The data presented at CRC 2026 demonstrate favorable safety and tolerability in participants treated to date. These findings support continued clinical development of our engineered Treg approach, which is designed to address the underlying autoimmune dysfunction responsible for disease progression in type 1 diabetes.”
Key Highlights from the Presentation
Key findings to be presented include:
- Favorable safety and tolerability profile in all participants treated to date
- Continued enrollment across 10 clinical sites in the United States
- Ongoing collection of biomarkers, cellular persistence data, continuous glucose monitoring metrics, insulin utilization data, and C-peptide measurements designed to evaluate durability of immunomodulation and preservation of beta cell function
About GNTI-122 and EngTreg Therapy
GNTI-122 is a novel, single-treatment, autologous engineered regulatory T cell (EngTreg) investigational therapy designed to restore immune tolerance by selectively suppressing autoreactive immune responses that drive type 1 diabetes. GNTI-122 cells are designed to migrate to the pancreas and associated lymphoid tissues and remain there to stably mitigate the immune response, preserving endogenous insulin production. GentiBio’s EngTreg platform builds on foundational discoveries in Treg biology, recognized by the 2025 Nobel Prize in Physiology or Medicine, and is designed to deliver targeted, durable immunomodulation with the goal of addressing the root cause of autoimmune disease.
About the POLARIS Study
Phase 1, Single Dose, Open-Label Study of GNTI-122 in Adults with Recently Diagnosed Type 1 Diabetes (T1D) (POLARIS; NCT06919354) is a clinical trial enrolling adults aged 18-55 years within 180 days of T1D diagnosis. The study evaluates the safety and tolerability of escalating doses of GNTI-122 and includes secondary and exploratory assessments of pharmacodynamic activity and clinical biomarkers, including measures of beta cell function. Participants are followed for up to 78 weeks.
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. GentiBio’s EngTregs harness the underlying power of Tregs and are engineered for precision, durability, and scalable manufacturing. GentiBio seeks to deliver disease modifying, and potentially curative, therapies for patients with significant unmet need. Learn more at Gentibio.com.
Contact
Media Email: Hatem.Heikal@gentibio.com
Clinical Email: Clinical_Ops@gentibio.com