Cambridge, Mass., May 29, 2026 – GentiBio, a clinical-stage biotechnology company advancing a pipeline of engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases, today announced it will present new clinical data at the 2026 American Diabetes Association (ADA) Conference, taking place June 5–8 in New Orleans, LA.
GentiBio is currently enrolling participants in its HLA Demographics Study (NCT NCT06860516)[KN2.1] evaluating the prevalence of the HLA DRB1*04:01 allele in U.S. adults with new-onset type 1 diabetes (T1D), an important marker associated with disease susceptibility and immune response.
At ADA 2026, GentiBio and collaborators will present HLA study data collected to date with demographics analysis. The presentation highlights the difference in HLA DRB1*04:01 distribution across diverse racial and ethnic populations. These findings further support GentiBio’s precision approach to engineered Treg therapy, integrating genetic, biomarker, and clinical insights to optimize patient selection and therapeutic response, including in the POLARIS Phase 1 clinical trial of GNTI-122 in adults recently diagnosed with T1D. Both the HLA Study and the POLARIS study are ongoing and continue to enroll adult participants recently diagnosed with T1D.
Poster Presentation
Title: Prevalence of HLA DRB1*04:01 in U.S. Adults with New Onset Type 1 Diabetes (T1D)
Poster Number: P2392
Presenters: Rachael Unger, University of North Carolina
Date/Time: Monday, June 8, 2026, 12:30 – 1:30 pm CDT
Location: New Orleans Ernest N. Morial Convention Center
The GentiBio team and collaborators will be available at the meeting to connect with clinicians, researchers, and members of the diabetes community to discuss the company’s progress advancing engineered Treg therapies, including the ongoing HLA Study and POLARIS clinical trial.
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.
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 manufacture. 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