Century Therapeutics Reports Sustained Glucose Control With iPSC-Derived Islets in Diabetic Mice, IND Soon
In rats, islets delivered through the liver’s portal vein had taken hold one month later, supporting the delivery route planned for clinical testing.
Key Points
- Century Therapeutics presented nonclinical data for CNTY-813, an induced pluripotent stem cell-derived islet replacement therapy for type 1 diabetes.
- Century reported that CNTY-813 maintained glycemic control until graft removal in a diabetic mouse study lasting more than eleven months.
- Century plans an IND submission in the fourth quarter of 2026, subject to completion of remaining IND-enabling studies, with initial clinical data anticipated in the second half of 2027.
Century Therapeutics, a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for type 1 diabetes and other autoimmune diseases, presented nonclinical data for CNTY-813, its iPSC-derived islet replacement therapy engineered with Allo-Evasion 5.0. The data were presented on October 2, 2026, at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan, Italy.
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Century reported sustained glycemic control in diabetic mice, product consistency across five clinical-scale batches, glycemic control after extended product cold storage, and engraftment via the intended clinical route of administration.
“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, Pharm.D., chief executive officer of Century Therapeutics.
Nonclinical findings
Century reported that Allo-Evasion 5.0-edited CNTY-813 islets rapidly restored normoglycemia in streptozotocin-induced diabetic mice and maintained glycemic control until graft removal in a study lasting more than eleven months. All mice administered CNTY-813 achieved normoglycemia. CNTY-813 islets showed glucose-stimulated insulin secretion potency similar to primary islets.
The company reported that its Phase 1 clinical manufacturing process produced consistent final product profiles across five clinical-scale batches from its Good Manufacturing Practice Master Cell Bank. The 29-day process exceeded purity criteria at every stage.
In rats, Century reported that CNTY-813 islets delivered through the liver portal vein were engrafted in the liver at one month post-transplant, supporting the planned clinical route of administration. Engrafted islets stained positive for chromogranin A, an endocrine cell marker, and for insulin, indicating retention of islet endocrine and beta cell identity after delivery.
Century also reported that mice transplanted with clinical-scale islets after 96 hours of cold storage normalized blood glucose within 30 days and maintained normoglycemia through three months of follow-up. By one month post-transplant, glucose tolerance was indistinguishable from normoglycemic controls.
Grant Welstead, Ph.D., senior vice president and head of research at Century, delivered the presentation, titled “CNTY-813: Scalable Production of Allo-Evasion™ 5.0-Engineered iPSC-Derived Islets for Off-the-Shelf Cell Therapies” (Presentation 225).
Development milestones
Century expects to submit an Investigational New Drug (IND) application for CNTY-813 in the fourth quarter of 2026, subject to completion of remaining IND-enabling studies. Initial safety and early efficacy data from the first-in-human study are anticipated in the second half of 2027.
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