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Sana Biotechnology Announces 6-Month Follow-Up Results From First-In-Human Study Transplanting UP421, Allogeneic Primary Islet Cell Therapy Engineered With Sana's HIP Technology, Into Patient With T1D Without Any Immunosuppression

Benzinga·06/23/2025 14:07:03
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Groundbreaking First-in-Human Study Establishes Potential to Treat Type 1 Diabetes by Transplanting Insulin-Secreting Cells Without Immunosuppression

Six-Month Patient Follow-up Results Demonstrate that Sana's Transplanted Pancreatic Islet Cells Modified with its Hypoimmune (HIP) Technology are Safe and Well-tolerated, Survive, Evade Detection by the Immune System, and Continue to Produce Insulin in the Patient

Function and Persistence of Pancreatic Islets Were Detectable by Production of Consistent Levels of Circulating C-Peptide, a Marker of Insulin Production, and Increased C-Peptide Levels with a Mixed Meal Tolerance Test (MMTT)

MRI Show Signals Consistent with Graft Survival Six Months after Transplantation

Study Continues to Evaluate Safety, Survival, and Function of Transplanted Cells

Data Shared at an Invited Presentation at the 85th Annual American Diabetes Association (ADA) Scientific Sessions Today

Sana is Incorporating the Tested Immune Evasion Technology to Develop SC451, a HIP-modified, Stem Cell-Derived Therapy as a One-Time Treatment for Patients with Type 1 Diabetes, with a Goal of Normal Blood Glucose, with No Insulin and No Immunosuppression

SEATTLE, June 23, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ:SANA), a company focused on changing the possible for patients through engineered cells, today announced six-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 (HIP) technology, into a patient with type 1 diabetes without any immunosuppression. The study is being conducted in partnership with Uppsala University Hospital. The results are consistent with and build upon the previously reported four-week and 12-week clinical results. Results of the study at six months after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase with a mixed meal tolerance test (MMTT), consistent with insulin secretion in response to a meal. 12-week PET-MRI scanning also demonstrated islet cells at the transplant site, a forearm muscle. The study identified no safety issues, and the HIP-modified islet cells evaded immune responses.