Cambridge, MA, August 22, 2025 — GentiBio, Inc., a leading biotechnology company developing engineered regulatory T cell (EngTreg) therapies designed to cure autoimmune and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has awarded Fast Track Designation to GNTI-122. The designation was granted, following FDA review of GNTI-122 for the treatment of recently diagnosed Type 1 Diabetes (T1D). GNTI-122 is a best-in-class autologous, engineered Treg cell therapy designed to reset the immune system, preserve pancreatic islet function and insulin production, potentially curing T1D in recently diagnosed patients.
Fast Track Designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. This designation underscores the potential of GNTI-122 to transform the treatment landscape for T1D by addressing the underlying immune dysregulation that drives disease progression. “We are encouraged by the FDA’s recognition of GNTI-122’s potential to meaningfully impact the lives of people with T1D,” said Mark Bach, Chief Medical Officer at GentiBio. “This designation will help accelerate our clinical development efforts and bring us closer to delivering a therapy that could preserve natural insulin production and prevent long-term complications associated with T1D.”
In addition to Fast Track designation, the GNTI-122 program recently received Orphan Drug Designation and IND clearance. Together, these designations can expedite GNTI-122 development through increased regulatory engagement, rolling regulatory review and eligibility for consideration for accelerated approval and priority review. GentiBio plans to initiate the POLARIS Study (NCT06919354), a Phase 1 clinical trial of GNTI-122 in adults with recently diagnosed T1D, in September 2025 at centers for diabetes treatment across the US. Additionally, GentiBio is currently enrolling recently diagnosed T1D patients in an HLA demographic study (NCT06860516) to investigate the prevalence of HLA types associated with T1D, and which may also identify potential candidates for participation in the POLARIS study.
About GentiBio, Inc.
GentiBio, Inc. is a biotherapeutics company co-founded by pioneers in Treg biology and immunology from Seattle Children’s Research Institute and Benaroya Research Institute to develop engineered regulatory T cells programmed to treat autoimmune and inflammatory diseases. GentiBio’s Series A financing was led by Matrix Capital Management with participation by Avidity Partners, JDRF T1D Fund, seed investors OrbiMed, RA Capital Management, Novartis Venture Fund, and Seattle Children’s Research Institute. GentiBio’s autologous and allogeneic engineered Treg platforms integrate key technologies designed to successfully (re)establish immune tolerance and overcome major limitations in existing Treg therapeutics. GentiBio is at the forefront of leveraging a unique therapeutic modality that has the potential to address the fundamental cause of many diseases that result from overactivity or malfunctioning of the immune system. To learn more, visit www.gentibio.com.
Media Contact:
Hatem Heikal
Vice President, Finance
Hatem.Heikal@GentiBio.com