Peer-Reviewed Letter to the Editor Describes Updated Long-Term Findings Consistent with Initial Trial Data Featured in NEJM Article Published in 2025
Seminal Study Successfully Achieved Primary and Secondary Endpoints, Demonstrating that Hypoimmune (HIP)-Modified Islets are Safe, Evade Detection by the Immune System, Survive, and Function Long-Term and Continue to Produce Insulin in the Patient for Over One Year Following Administration Without Immunosuppression
Sana Expects to File Investigational New Drug (IND) Application and Initiate Phase 1/2 Trial as Early as This Year for SC451, a HIP-Modified, Stem Cell-Derived Therapy Designed as a One-Time Treatment for Patients with Type 1 Diabetes, with a Goal of Long-Term Normal Blood Glucose Without the Need for Insulin Therapy or Immunosuppression
SEATTLE, July 13, 2026 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that The New England Journal of Medicine (NEJM) has published a peer-reviewed Letter to the Editor by clinicians at Uppsala University Hospital highlighting 14-month follow-up data from an investigator-sponsored study of UP421, an allogeneic primary human pancreatic islet cell therapy engineered with Sana's hypoimmune platform (HIP) technology, showing that the transplantation of HIP-modified insulin-secreting cells has the potential to treat type 1 diabetes without the use of immunosuppressants.
"We are excited to have our study data once again highlighted in The New England Journal of Medicine," said Per-Ola Carlsson, MD, Study Principal Investigator, Senior Physician and Professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital. "After a century of relying on insulin, people living with type 1 diabetes deserve more than incremental improvements. With this 14-month follow-up data using the hypoimmune technology, we believe that a functional cure for type 1 diabetes without immunosuppression is possible."
The long-term findings provide further evidence that HIP-modified cells are safe and can evade both allogeneic and autoimmune rejection with durable function, supporting the potential of Sana's HIP-modified, stem cell-derived pancreatic islet cell therapy, SC451, as a broadly accessible one-time treatment for patients with type 1 diabetes, with the goal of long-term normal blood glucose without the need for insulin therapy or immunosuppression.
Gary Meininger, MD, Sana's Executive Vice President, Chief Medical Officer, added, "We continue to be encouraged by these results, which demonstrate the promise of our HIP-modified cells and their potential as a significant medical breakthrough for people living with type 1 diabetes. The recognition by the NEJM of the importance of these longer-term follow-up data is notable. As we advance SC451 toward a Phase 1/2 study, we are inspired by the opportunity to move beyond lifelong disease management and toward restoring natural glucose control. Our goal is to make a one-time, functional cure without the need for immunosuppression for individuals living with type 1 diabetes."