Groundbreaking First-in-Human Study Demonstrates Potential to Treat Type 1 Diabetes by Transplanting Insulin-Secreting Cells Without Immunosuppression

14-Month Follow-up Data Show Hypoimmune (HIP)-Modified Islets are Safe, Evade Detection by the Immune System, Survive Long-Term, and Continue to Produce Insulin

C-Peptide Levels at Month 14 Comparable to Initial Six Months of Study; Results Highlight the Importance of Improved Glycemic Control on Islet Function

Full 14-Month Data to Be Presented Today at the Advanced Technologies & Treatments for Diabetes (ATTD) Conference

Sana is Leveraging Validated HIP Technology to Develop SC451, a HIP-Modified, Stem Cell-Derived Therapy, Designed as a One-Time Treatment for Patients with Type 1 Diabetes, with a Goal of Normal Blood Glucose without Insulin or Immunosuppression

Sana Expects to File Investigational New Drug (IND) Application for SC451 in Type 1 Diabetes and Initiate Phase 1 Trial as Early as This Year

SEATTLE, March 13, 2026 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ:SANA), a company focused on changing the possible for patients through engineered cells, today announced 14-month follow-up results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with Sana's hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without any immunosuppression. The study is being conducted in partnership with Uppsala University Hospital.

Results from more than 1 year after cell transplantation demonstrate sustained survival and function of pancreatic beta cells, as measured by the presence of circulating C-peptide, a biomarker of endogenous insulin production by the transplanted beta cells. C-peptide levels also increase in response to a mixed meal tolerance test (MMTT), consistent with insulin secretion in response to a meal. Fasting and MMTT-stimulated C-peptide levels at month 14 are comparable to those observed in the first six months of the study and exceed levels measured at months 9 and 12. Between months 12 and 14, the patient achieved tighter glycemic control, and the improved insulin secretion at month 14 underscores the importance of glucose control in optimizing pancreatic beta cell function. No safety issues were identified in the study.