Sana Biotechnology announced positive initial results from a first-in-human study involving a patient with type 1 diabetes. The study, conducted in partnership with Uppsala University Hospital, transplanted allogeneic pancreatic islet cells engineered with Sana’s hypoimmune (HIP) technology without immunosuppression. The transplanted cells survived, functioned, and evaded immune detection, evidenced by C-peptide production, increased C-peptide levels after meals, and MRI scans indicating graft survival at four weeks.
This breakthrough holds significant potential for revolutionizing type 1 diabetes treatment. The ability to transplant islet cells without immunosuppression could eliminate the need for lifelong anti-rejection drugs, significantly improving patients’ quality of life and reducing the risk of complications. This success also suggests that a scalable, curative treatment for type 1 diabetes, enabling normal blood glucose levels without insulin injections or immunosuppression, may be within reach.
The study achieved its primary objective of demonstrating safety. Secondary endpoints, including cell survival, immune evasion, and C-peptide production, were also met. C-peptide, a biomarker indicating insulin production by transplanted beta cells, was detected at each weekly blood draw and increased after meals. MRI scans confirmed graft survival. This is potentially the first instance of allogeneic transplant survival without immunosuppression or immune-protective devices in a fully immune competent individual.
This early success validates Sana’s HIP technology platform and provides valuable insights for the development of SC451, Sana’s HIP-modified, stem cell-derived islet cell program. The results suggest a future where cell therapies can replace insulin-producing cells without immunosuppression, offering a potential cure for type 1 diabetes and potentially impacting other diseases requiring transplantation. Further research and longer-term follow-up are necessary to confirm the durability of these results and assess the long-term efficacy of this approach.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
