In a 14-month follow-up, Sana Biotechnology has found that its investigational allogeneic cell therapy continued to produce insulin in 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 showing the therapy avoided immune rejection and was associated with consistent levels of c-peptide expression, a biomarker indicating whether 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 13 March 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 glycaemic control between 12 and 14 months, with insulin secretion improving at month 14.
