Cambridge, Mass., April 29, 2026 — GentiBio, a clinical-stage biotechnology company advancing engineered regulatory T cell (Treg) therapies to treat autoimmune and inflammatory diseases, today announced that it will present new data on GNTI-122, an engineered Treg therapy in development for Type 1 diabetes, at the 2026 Pediatric Endocrine Society (PES) Annual Meeting on Saturday, May 2.
The poster highlights new data demonstrating the manufacturability and clinical readiness of GNTI-122 and supports continued awareness of GentiBio’s POLARIS Phase 1 clinical trial evaluating GNTI-122 in newly diagnosed individuals. In addition, the poster presents a comprehensive phenotypic and functional comparability analysis from research-scale GNTI-122 and full-scale GMP drug product.
These findings represent an important step in translating engineered Treg therapies from research to clinical use, underscoring GentiBio’s ability to produce consistent, high-quality, functional cell therapies at clinical scale.
Poster Presentation
Chandra Patel, SVP, R&D Operations
“Manufacturability and Clinical Readiness of GNTI-122: Phenotypic and Functional Comparability Between Research-Scale and GMP Drug Product”
Saturday, May 2 | Morning Session
Chandra Patel will be available at the meeting to connect with clinicians and researchers in pediatric endocrinology and 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 18–45 years within 120 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 www.gentibio.com.
Contact
Media email: Hatem.Heikal@gentibio.com
Clinical Email: Clinical_Ops@gentibio.com