PHILADELPHIA, PA — Century Therapeutics, Inc. (NASDAQ: IPSC) remains on track to seek U.S. clearance in the fourth quarter to begin clinical testing of CNTY-813, its experimental type 1 diabetes cell therapy, after nonclinical studies demonstrated sustained glucose control, consistent manufacturing and successful engraftment.
The company expects initial safety and early efficacy data from a first-in-human study in the second half of 2027, subject to completion of remaining studies supporting its Investigational New Drug application.
Century presented updated CNTY-813 data at the European Association for the Study of Diabetes annual meeting in Milan, including results from an experiment lasting more than 11 months.
CNTY-813 is an induced pluripotent stem cell-derived islet replacement therapy intended to restore insulin-producing cells in people with type 1 diabetes. The cells incorporate Century’s Allo-Evasion 5.0 engineering, which is designed to help them evade immune rejection.
In a streptozotocin-induced diabetic mouse model, all animals receiving CNTY-813 reached normal blood glucose levels, which were maintained until the implanted cells were removed. The engineered islets also demonstrated glucose-stimulated insulin secretion comparable to primary islets.
The findings remain preclinical and do not establish whether the therapy will produce similar results in people.
Century also reported consistent final product profiles across five clinical-scale batches produced from its Good Manufacturing Practice Master Cell Bank. Its 29-day manufacturing process met purity criteria at each stage.
The manufacturing data are significant to the company’s effort to develop CNTY-813 as an off-the-shelf therapy, which would require Century to reliably produce standardized cell products at clinical scale.
Additional experiments tested the company’s planned method of administering CNTY-813 through the liver’s portal vein. Researchers found engrafted islets in rat livers one month after transplantation, with markers indicating the cells retained endocrine and insulin-producing beta-cell characteristics.
Century also tested whether the product could withstand the storage conditions required for a clinical supply chain.
Mice receiving clinical-scale islets after 96 hours of cold storage reached normal blood glucose levels within 30 days and maintained them through three months of follow-up. Glucose tolerance after one month was comparable to non-diabetic controls.
The company previously held a pre-IND meeting with the U.S. Food and Drug Administration. Chief Executive Officer Brent Pfeiffenberger said Century reached “general alignment” with the agency on its nonclinical package, Phase 1 manufacturing process and proposed Phase 1/2 trial design.
Century expects to submit its IND application during the fourth quarter, provided the remaining IND-enabling work is completed.
The latest results extend nonclinical findings Century presented in June and move CNTY-813 closer to the point at which its immune-evasion strategy and islet-replacement approach can be evaluated in patients.
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