Sana Biotechnology announced the publication in the New England Journal of Medicine of clinical data from a first‑in‑human trial evaluating transplantation of hypoimmune (HIP)–modified pancreatic islet cells into a patient with type 1 diabetes, conducted without immunosuppression.
According to the company, the trial involved a 42‑year‑old patient with long‑standing type 1 diabetes, and results showed that the transplanted HIP‑modified islet cells were safe, well‑tolerated, evaded both autoimmune and allogeneic immune detection, persisted over time, and continued to secrete insulin in a glucose‑dependent manner. Cell survival at the transplant site was confirmed via PET‑MRI imaging, and circulating C‑peptide—a marker of insulin production—emerged in response to mixed meal tolerance testing after being undetectable before transplantation.
The company said that six‑month follow‑up data presented at recent scientific congresses reinforced these findings, affirming sustained cell survival and function.
According to the company, these results underscore the potential of its HIP platform to enable cell therapy without the need for immunosuppressive treatment and may be generalizable across multiple cell types and populations.
The company said that it is applying the HIP technology to develop a stem cell–derived candidate, SC451, aiming for a single‑treatment therapy that achieves normal blood glucose without insulin or immunosuppression. The company intends to file an IND as early as 2026.
