In a 14-month follow-up, Sana Biotechnology has found that its investigational allogeneic cell therapy continued to produce insulin for one patient with Type 1 diabetes, with no safety concerns reported.
The Seattle-based biotech is evaluating UP421, a donor-derived primary islet cell therapy transplanted into the patient’s arm and designed to serve as a Type 1 diabetes treatment that doesn’t require the use of any immunosuppression.
Previously, the biotech shared four-week data that found the therapy avoided immune rejection and was tied to consistent levels of c-peptide expression, a biomarker that indicates if the transplanted beta cells are producing insulin. At the time, Citi analysts said that the data “pave the way for a potentially transformative cure,” for a disease that affects more than 1.7 million Americans.
Now, Sana has revealed that its hypoimmune (HIP)-modified islets continued to avoid detection from the patient’s immune system for over a year, according to a March 13 release.
The therapy also continued to elicit insulin levels at 14 months that were comparable to the levels produced during the first six months of the study, Sana said.
The new findings also showed “sustained survival and function of pancreatic beta cells, as measured by the presence of circulating C-peptide,” the Sana release reads.
C-peptide levels also rose with a mixed meal tolerance test (MMTT)—a liquid meal designed to demonstrate how much insulin is being generated—which aligns with insulin secretion in response to a meal. At Month 14, fasting and MMTT-stimulated C-peptide levels were similar to those recorded during the first six months, while surpassing levels seen at nine and 12 months.
The patient experienced tighter glycemic control between 12 and 14 months, with insulin secretion improving at Month 14.
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Sana now plans on submitting an investigational new drug (IND) application to the FDA for SC451, a HIP-modified, stem cell-derived therapy based around the UP421 technology. SC451 is designed to serve as a one-time treatment for Type 1 diabetes, with Sana hoping to launch a phase 1 trial this year.
“This work suggests that the hypoimmune technology has the potential to enable a functional cure for type 1 diabetes without immunosuppression, and we look forward to working with Sana as it brings forward SC451, a more scalable approach, at higher doses,” Per-Ola Carlsson, M.D., principal investigator of the study, plus physician and professor at Uppsala University Hospital’s endocrinology and diabetology clinic, said in the release.
The detailed 14-month findings are expected to be presented today at the Advanced Technologies and Treatments for Diabetes Conference in Spain.
Since market open, Sana’s stock has risen slightly, up 7% to $3.3 per share at 11 a.m. ET today.
