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Sana Biotechnology Announces Publication in New England Journal of Medicine of Groundbreaking Clinical Data from Transplantation Without Immunosuppression of Hypoimmune-Modified, Insulin-Producing Islet Cells in Patient with Type 1 Diabetes
GlobeNewswireยท 2025-08-04 15:35
Core Insights - The study demonstrates that Sana's hypoimmune (HIP)-modified pancreatic islet cells can be transplanted without immunosuppression, showing persistence and insulin production over time in a patient with type 1 diabetes [1][2][6] - The results indicate a significant advancement towards a functional cure for type 1 diabetes, as the patient was able to produce insulin independently for the first time in over 35 years [2][3] - The company plans to file an Investigational New Drug application for SC451, a HIP-modified stem cell-derived therapy, as early as 2026 [1][2] Study Findings - The study involved the transplantation of HIP-modified pancreatic islet cells into a 42-year-old patient, with results showing that these cells evade immune detection and continue to function [1][9] - Six-month follow-up results confirmed the survival and function of the transplanted cells, indicated by the presence of circulating C-peptide, a biomarker for insulin production [7][9] - MRI scans showed consistent signals at the transplant site, confirming graft survival [9] Technology and Development - Sana's HIP platform is designed to create cells that can evade the immune system, allowing for the transplantation of allogeneic cells without the need for immunosuppression [8][10] - The company is developing multiple therapeutic candidates using this platform, including stem cell-derived pancreatic islet cells and CAR T cells for various diseases [8][10] - The ongoing study is supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust, emphasizing the significance of the research [5]