Sana Biotechnology announces publication on clinical data from transplantation

Sana Biotechnology (SANA) announced that the New England Journal of Medicine has published a journal article titled “Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression”. 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 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. No serious adverse events or adverse events possibly or probably related to UP421 were identified in the study. HIP-modified pancreatic islet cells, transplanted with no immunosuppressive medicines, including no glucocorticoids, evade immune detection and rejection. Pancreatic islet cells survive and function post-transplantation. The survival and function of the HIP-modified pancreatic beta cells was confirmed at each blood draw, as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels increase during monthly mixed meal tolerance tests, showing increased insulin secretion in response to a meal. Of note, prior to transplant, the patient had undetectable C-peptide both when fasting and during an MMTT. MRI scans at each month show a sustained and consistent signal at the site of cell transplantation, consistent with graft survival. A PET-MRI scan with a tracer targeting pancreatic beta cells confirms that the surviving cells are, in fact, pancreatic beta cells.