Sana Biotechnology, Inc. announced that The New England Journal of Medicine (NEJM) has published a peer-reviewed Letter to the Editor highlighting 14-month follow-up data from an investigator-sponsored study of UP421. The data indicates that hypoimmune (HIP)-modified islet cells can safely evade detection by the immune system, survive, and function long-term without the need for immunosuppression in patients with type 1 diabetes.

The study, conducted by clinicians at Uppsala University Hospital, demonstrated that the patient achieved detectable levels of C-peptide, a biomarker for insulin production, at 14 months post-transplantation. These levels were comparable to those observed in the first six months and exceeded measurements taken at months 9 and 12. Additionally, 52-week PET-MRI scanning confirmed the presence of islet cells at the transplant site in the forearm muscle.

Study Findings and Clinical Implications

The long-term findings support the potential of Sana’s HIP-modified, stem cell-derived pancreatic islet cell therapy, SC451. The company is advancing SC451 as a one-time treatment designed to achieve long-term normal blood glucose without the need for insulin therapy or immunosuppression.

Future Development Plans

Sana Biotechnology expects to file an Investigational New Drug (IND) application and initiate a Phase 1/2 trial for SC451 as early as this year. The investigator-sponsored study of UP421 is supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust and evaluates the safety of HIP-modified insulin-producing pancreatic islet cells transplanted without simultaneous immunosuppressive medicines.

Sana Biotechnology, Inc. (NASDAQ: SANA) will present clinical data from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with its hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without immunosuppression. The presentation will take place at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026, scheduled from September 28 to October 2, 2026, in Milan, Italy. The symposium will highlight data from the study, which evaluates the use of UP421 in a type 1 diabetes patient without the need for immunosuppression. This approach leverages Sana’s HIP technology to engineer allogeneic primary islet cells, aiming to reduce immune rejection risks.

Key Details of the Presentation

The EASD Annual Meeting 2026 will provide a platform for discussing the clinical implications of this study. Sana’s focus on engineered cells aims to address unmet medical needs in diabetes treatment.