Genti in the News

June 09, 2026

GentiBio to Present Clinical Data on GNTI 122 in Recent-Onset Type 1 Diabetes at the 2026 Endocrine Society (ENDO) Annual Meeting

Cambridge, Mass., June 09, 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 an update on the Phase 1 clinical study of GNTI 122 at the 2026 Endocrine Society (ENDO) Annual Meeting, taking place June 10–13 in Chicago, Illinois.

GentiBio is currently enrolling patients in its Phase 1 POLARIS clinical trial evaluating GNTI 122 in individuals with recently diagnosed Type 1 diabetes (T1D). More information about the trial can be found at PolarisStudy.com.

At ENDO 2026, GentiBio will present updated progress on the ongoing POLARIS study, including clinical development and biomarker strategy, supporting the evaluation of engineered regulatory T cell therapy in recent-onset T1D. These data highlight the continued progress of GNTI 122 in the clinic and the company’s efforts to translate engineered Treg biology into meaningful therapeutic outcomes.

These findings represent an important step in advancing engineered Treg therapies in endocrine and autoimmune diseases and further support GentiBio’s approach to restoring immune tolerance through targeted, durable cell therapy.

Poster Presentation

Title: Early-phase clinical evaluation of GNTI 122, an engineered regulatory T cell therapy, in recent-onset type 1 diabetes
Presenter: Mark Bach
Date: Saturday, June 13, 2026
Poster Number:
SAT-568

The GentiBio team will be available at the meeting to connect with clinicians, researchers, and members of the endocrine community to discuss the company’s progress in advancing engineered Treg therapies, including the ongoing 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

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