Century Therapeutics shares nonclinical data for iPSC-derived diabetes therapy

Century Therapeutics (NASDAQ: IPSC) presented nonclinical data for CNTY-813, its iPSC-derived islet replacement therapy for type 1 diabetes, at the 62nd Annual Meeting of the European Association for the Study of Diabetes in Milan, Italy.

The data showed CNTY-813 maintained glycemic control in a diabetic mouse model for over eleven months until graft removal. All mice administered with CNTY-813 achieved normoglycemia, and the therapy demonstrated glucose-stimulated insulin secretion potency similar to primary islets.

Five clinical-scale batches produced from Century's Good Manufacturing Practice Master Cell Bank yielded consistent final product profiles across a 29-day manufacturing process. In rat studies, CNTY-813 islets were identified engrafted in the liver one month after transplant via the planned clinical route of liver portal vein delivery, retaining islet endocrine and beta cell identity.

Mice transplanted with clinical-scale product after 96 hours of cold storage normalized blood glucose within 30 days and maintained normoglycemia through three months of follow-up.

According to a statement from the company, Century reached general alignment with the FDA on its nonclinical package, Phase 1 manufacturing process, and proposed Phase 1/2 trial design following a pre-IND meeting.

"Following our pre-IND meeting, in which we reached general alignment with FDA on our nonclinical package, Phase 1 manufacturing process and proposed Phase 1/2 trial design, we remain on track to submit the CNTY-813 IND in the fourth quarter of this year with initial clinical data anticipated in the second half of 2027," said Brent Pfeiffenberger, Chief Executive Officer of Century Therapeutics.

The company expects to submit an Investigational New Drug application for CNTY-813 in the fourth quarter of 2026, subject to completion of remaining IND-enabling studies, with initial safety and early efficacy data from a first-in-human study anticipated in the second half of 2027.

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