Sana Biotechnology announced six-month follow-up results from a first-in-human study transplanting HIP-modified (hypoimmune) allogeneic islet cells (UP421) into a patient with type 1 diabetes without immunosuppression. The study, conducted in partnership with Uppsala University Hospital, demonstrated the transplanted cells survived, functioned by producing insulin (indicated by C-peptide levels), and evaded immune system detection. The study builds upon earlier positive results at four and 12 weeks.
This development holds significant promise for a potential functional cure for type 1 diabetes. The ability to transplant islet cells without immunosuppression could revolutionize diabetes care, eliminating the need for lifelong insulin injections and the risks associated with immunosuppressive drugs. This advance moves beyond incremental improvements in insulin delivery and addresses the underlying cause of the disease, offering a potential path towards normal blood glucose control.
Six-month data confirms the continued presence and function of transplanted islet cells. C-peptide, a byproduct of insulin production, was consistently detected, indicating the cells were producing insulin. Furthermore, C-peptide levels increased after a mixed meal tolerance test, demonstrating the transplanted cells responded appropriately to food intake. Imaging confirmed the presence of islet cells at the transplant site. Importantly, no safety issues were observed, and the modified cells successfully evaded immune rejection. The tested technology is being incorporated into Sana’s SC451 program, a stem cell-derived islet cell therapy, with a planned Investigational New Drug (IND) application next year.
The positive six-month results suggest HIP technology could enable safe and effective islet cell transplantation without immunosuppression, representing a potential breakthrough in type 1 diabetes treatment. This outcome supports further development of cell therapies for diabetes and potentially other autoimmune diseases, paving the way for a future where a one-time treatment could restore normal blood glucose control, freeing patients from the burden of daily insulin management.
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.
