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Data Demonstrate that Sana's Hypoimmune (HIP)-Modified Pancreatic Islet Cells, Transplanted with No Immunosuppression, Persist and Function Over Time in Patient with Type 1 Diabetes
Study Establishes Ability to Genetically Modify and Transplant Pancreatic Islet Cells Without Immunosuppression and Overcome Both Allogeneic and Autoimmune Rejection
Six-Month Patient Follow-up Results Presented at the 85th Annual American Diabetes Association (ADA) Scientific Sessions Further Demonstrate that Sana's HIP-Modified Pancreatic Islet Cells are Safe and Well-tolerated, Survive, Evade Detection by the Immune System, and Continue to Produce Insulin in the Patient
Sana Is Incorporating its HIP 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
Recent FDA INTERACT Meeting Increases Confidence in Moving Forward with GMP Master Cell Bank for SC451 and in Filing SC451 Investigational New Drug Application (IND) as Early as 2026
Sana Expects Study Data to Be Generalizable across Multiple Cell Types and Patient Populations
SEATTLE, Aug. 04, 2025 (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 journal article titled "Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression" (DOI: 10.1056/NEJMoa2503822). The article discusses 12-week results from an investigator-sponsored trial, conducted at Uppsala University Hospital, evaluating the transplantation of UP421, a primary human pancreatic islet cell therapy engineered with Sana's hypoimmune (HIP) technology, without the use of immunosuppressive medications in a 42-year-old patient living with type 1 diabetes for over three decades. The intramuscular transplantation of HIP-modified pancreatic islet cells is safe and well-tolerated and demonstrates that these cells evade autoimmune and allogeneic immune recognition, persist, and secrete insulin in a glucose-dependent manner over the 12-week evaluation period reported in the article. 12-week PET-MRI scanning also confirmed islet cells at the transplant site. Six-month data, described below, were recently presented at the ADA meeting and presented today at the World Transplant Congress 2025 concurrently with the publication of the NEJM article.
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