Key Takeaways
- Sana Biotechnology reported continued insulin production in a Type 1 diabetes patient 14 months after receiving UP421 cell therapy.
- The hypoimmune-modified islets showed sustained function and avoided immune system detection without safety concerns.
- Sana aims to file an IND application for SC451, a stem cell-derived therapy based on UP421, targeting a scalable treatment for Type 1 diabetes.
Continued Progress in Cell Therapy for Type 1 Diabetes
Sana Biotechnology announced promising results from a 14-month follow-up study of its investigational allogeneic cell therapy, UP421, aimed at treating Type 1 diabetes. The study showed that a patient receiving the therapy maintained insulin production without any reported safety issues. This development is significant, given that Type 1 diabetes affects over 1.7 million Americans.
UP421 is a donor-derived primary islet cell therapy designed for transplantation into the patient’s arm, eliminating the need for immunosuppression. Initial findings showed that the therapy successfully avoided immune rejection and maintained consistent c-peptide levels, a biomarker that indicates insulin production.
The recent findings indicated that the hypoimmune (HIP)-modified islets continued to evade detection from the immune system beyond the 14-month mark. Insulin levels remained stable, comparable to the first six months of the study. Additionally, the presence of circulating C-peptide confirmed sustained survival and functionality of the pancreatic beta cells.
A mixed meal tolerance test (MMTT) also demonstrated improved c-peptide levels, which reflect insulin generation in response to food intake. At the 14-month checkpoint, both fasting and MMTT-stimulated c-peptide levels matched those recorded in the initial six months and exceeded levels seen at the nine and twelve-month assessments. Moreover, the patient experienced enhanced glycemic control between the 12- and 14-month evaluations.
Sana Biotechnology is gearing up to submit an investigational new drug (IND) application to the FDA for SC451, a stem cell-derived therapy stemming from the UP421 technology. SC451 is anticipated to serve as a single-treatment solution for Type 1 diabetes, with plans for a phase 1 trial to initiate later this year.
Per-Ola Carlsson, M.D., principal investigator of the study and physician at Uppsala University Hospital, commented on the potential of the hypoimmune technology: “This work suggests that the hypoimmune technology has the potential to enable a functional cure for type 1 diabetes without immunosuppression.” The excitement surrounding SC451 highlights its promise as a more scalable approach to treatment at higher doses.
Sana’s ongoing research will be discussed further at the Advanced Technologies and Treatments for Diabetes Conference in Spain, where the detailed 14-month findings will be presented. As a result of this positive news, Sana’s stock experienced a slight increase, rising 7% to $3.3 per share shortly after the market opened.
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