Sana, Uppsala announce authorization of first-in-human study of UP421

Sana Biotechnology and Uppsala University Hospital in Sweden announced the Swedish Medical Products Agency has authorized Uppsala University’s Clinical Trial Application, CTA, to initiate an investigator-sponsored, first-in-human study of UP421, an allogeneic, primary islet cell therapy engineered with Sana‘s hypoimmune, HIP, technology, in patients with type 1 diabetes. The goal of UP421 treatment is to provide proof of concept for transplanting functional islet cells without immunosuppression. UP421 is engineered using Sana’s hypoimmune platform modifications with the goal of evading both allogeneic and autoimmune rejection. The study is designed with endpoints of safety, cell survival, immune evasion, and C-peptide production. Insights from this study may inform development of Sana’s SC451, a hypoimmune-modified stem-cell derived islet cell therapy for patients with type 1 diabetes. “Islet cell transplantation has shown curative potential for patients with type 1 diabetes, but the need for concurrent immunosuppression has led to side effects, limited efficacy, and decreased utilization. Sana’s hypoimmune platform has shown the potential to evade both allogeneic and autoimmune rejection in preclinical models, and we look forward to seeing if these insights translate into patients, providing a path to cell transplantation without immunosuppression,” said Steve Harr, Sana’s President and CEO. “The team at Uppsala has significant experience in primary islet cell manufacturing, transplantation, and clinical care of these patients, and we look forward to seeing the results from this clinical study and applying learnings to SC451.”