Uppsala University’s CTA has been authorised by the Swedish MPA to initiate an investigator-sponsored trial of UP421 in patients with type 1 diabetes. Credit: Sirikarn Rinruesee / Shutterstock.com.

Sana Biotechnology and Sweden-based Uppsala University Hospital have announced the authorisation of the clinical trial application (CTA) for the study of a primary islet cell treatment for patients with type 1 diabetes (T1D).

Uppsala University’s CTA has received authorisation from the Swedish Medical Products Agency (MPA) to initiate the investigator-sponsored, first-in-human trial of UP421 in these patients.

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UP421 is an allogeneic, primary islet cell therapy designed using Sana’s hypoimmune (HIP) technology.

Treatment with UP421 is aimed at offering proof of concept for transplanting functional islet cells without immunosuppression. It is intended to evade both allogeneic and autoimmune rejection.

Safety, immune evasion, cell survival and C-peptide production are the endpoints of the study.

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The insights from this study are expected to contribute to the development of Sana’s SC451, a hyperimmune-modified stem-cell-derived islet cell therapy for T1D patients.

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Sana president and CEO Steve Harr said: “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 utilisation.

“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.”

The company is using hypoimmune technology for donor-derived allogeneic T cells to make potent CAR T cells, as well as pluripotent stem cells to differentiate multiple cell types.

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