— First and Best-in-class engineered regulatory T cell therapy aims to preserve natural insulin production and prevent progression to established T1D —
Boston, MA, July 11, 2025 — GentiBio Inc., a clinical-stage biotechnology company pioneering engineered regulatory T cell (EngTreg) therapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for GNTI-122, a transformative autologous EngTreg cell therapy poised to fundamentally change the treatment paradigm for Type 1 Diabetes (T1D) patients. The goal with GNTI-122 is to effectively cure T1D by preventing the immune destruction of the insulin producing cells in the pancreas.
GNTI-122 is designed to preserve endogenous insulin production by targeting the autoimmune attack at its source. By intervening early in the disease course, GNTI-122 has the potential to prevent the progression of T1D and transform the standard of care for recently diagnosed patients.
“This IND acceptance marks a pivotal milestone for GentiBio and for the field of immune tolerance,” said Andy Walker, Ph.D., Chief Executive Officer of GentiBio. “GNTI-122 embodies our vision of restoring immune system balance, rather than just managing symptoms. We’re excited to bring this therapy into the clinic and be one step closer to changing the lives of people with T1D.”
GNTI-122 leverages GentiBio’s proprietary platform to engineer Tregs with enhanced stability, specificity, and IL-2 support. The therapy is designed to selectively stop the autoimmune attack on pancreatic beta cells, preserving the body’s natural ability to produce insulin.
“By engineering Tregs to be more potent and precise, we’re aiming to halt disease progression before irreversible damage occurs. It’s a paradigm shift in how we think about immune intervention.” said Tom Wickham, Ph.D., Chief Scientific Officer.
The Phase 1 clinical trial will evaluate the safety, tolerability, and biological activity of GNTI-122 in individuals recently diagnosed with T1D. The trial will also assess the therapy’s ability to preserve C-peptide levels, a key marker of endogenous insulin production.
“For patients and families facing a T1D diagnosis, the possibility of maintaining natural insulin production is life-changing,” said Mark Bach, M.D., Ph.D., Chief Medical Officer. “Our goal is to intervene early enough to preserve function and potentially prevent the need for lifelong insulin therapy.”
GentiBio expects to initiate the POLARIS Phase 1 trial, NCT06919354, in the coming months and will share additional details as the study progresses.
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 Tregs 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 and/or malfunctioning of the immune system. To learn more, visit www.gentibio.com.
Media Contact
Hatem Heikal
Vice President, Finance
Hatem.Heikal@GentiBio.com