Sana Biotechnology’s first-in-human study has provided evidence that the company’s hypoimmune technology enables transplanted islet cells to avoid immune rejection and produce insulin without immunosuppression.
The study, conducted in partnership with Uppsala University Hospital, transplanted UP421, an allogeneic primary islet cell therapy engineered with Sana’s HIP technology, into one patient with type 1 diabetes without the use of any immunosuppression.
According to Sana, results at four weeks 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 increased with a mixed meal tolerance test (MMTT) — considered the gold-standard measure of insulin secretion in type 1 diabetes. MRI scanning also demonstrated a sustained signal at the site of transplanted cells over time, which is consistent with graft survival.
The study identified no safety issues, and the HIP-modified islet cells evaded immune responses.
Primary islet cell transplantation with immunosuppression, an established procedure in type 1 diabetes, involves isolating pancreatic islet cells from a deceased donor’s pancreas and transplanting them into a patient. Historically, suppression of the recipient’s immune system has been required to prevent immune rejection of the allogeneic transplanted cells and resurgence of the inciting autoimmune attack. Sana’s HIP technology is designed to overcome the immunologic rejection of allogeneic cells, and in type 1 diabetes, evade the autoimmune rejection of pancreatic beta cells.
“In type 1 diabetes, a person’s immune system attacks and destroys the beta cells. Today’s data, when combined with progress elsewhere in the field, provide real hope that a scalable, curative treatment for patients with type 1 diabetes, meaning normal blood glucose with no insulin injections or immunosuppression, is possible,” said Per-Ola Carlsson, M.D., study principal investigator, senior physician and professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital.
Sana says it will continue to evaluate the patient transplanted with hypoimmune-edited islet cells and plans to share additional data at an upcoming scientific meeting
Subscribe to our e-Newsletters
Stay up to date with news, articles and insights relevant to cell and gene therapy development and manufacturing. Plus, get special offers from Cell & Gene Therapy Review delivered right to your inbox!
Sign up now!