Century Therapeutics' CNTY-813 hits IND-readiness milestones at EASD
Century Therapeutics has presented a package of nonclinical data for CNTY-813, its induced pluripotent stem cell (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. The data, delivered in an oral session on 2 October, are designed to support an Investigational New Drug application the Philadelphia-based company expects to file in Q4 2026.
The presentation built on preclinical findings Century disclosed at the American Diabetes Association meeting in June, adding new evidence on manufacturing consistency, cold-chain stability, and the intended clinical route of administration. All four areas directly address typical FDA expectations for an IND package in a novel cell therapy programme.
What the data show
In a diabetic mouse model, CNTY-813 islets engineered with Century's proprietary Allo-Evasion 5.0 immune-evasion platform rapidly restored normal blood glucose and maintained glycaemic control for the duration of the study, which ran for more than eleven months until graft removal. Glucose-stimulated insulin secretion potency was reported to be comparable to primary human islets. In a separate arm, mice transplanted with clinical-scale product that had been cold-stored for 96 hours normalised blood glucose within 30 days and maintained that response through three months of follow-up.
On the manufacturing side, five consecutive clinical-scale batches from Century's Good Manufacturing Practice master cell bank produced consistent final product profiles over a 29-day process, with purity criteria met at every stage. In rats, delivery via the liver portal vein resulted in confirmed engraftment at one month, with islets staining positive for chromogranin A and insulin, indicating retention of endocrine and beta-cell identity after transplant.
Chief executive Brent Pfeiffenberger said the results reflected "continued execution" following a pre-IND meeting with the FDA in which the company reached general alignment on the nonclinical package, Phase 1 manufacturing process, and proposed Phase 1/2 trial design. Initial safety and early efficacy data from the first-in-human study are anticipated in the second half of 2027.
Market context and competitive landscape
The iPSC-derived islet space is becoming one of the more active frontiers in cell therapy for metabolic disease, with several academic groups and a small number of well-capitalised biotechs working towards off-the-shelf products that remove the donor dependency and immunosuppression burden of traditional cadaveric islet transplantation. Vertex Pharmaceuticals, whose VX-880 and VX-264 programmes use embryonic stem cell-derived islets, has already generated human proof-of-concept data and represents the closest public benchmark for CNTY-813. Century's differentiating claim rests on the Allo-Evasion platform, which the company argues could reduce or eliminate the need for chronic immunosuppression by engineering the cells to evade host immune rejection without requiring a physical encapsulation device.
The regulatory path for this class of therapy remains complex. Both the FDA and the EMA classify iPSC-derived cellular products as advanced therapy medicinal products or their equivalent, demanding robust characterisation data across multiple cell batches. The consistency data across five clinical-scale runs directly addresses this requirement and will be central to any IND review.
For Century, the IND filing also carries commercial significance. The company trades on NASDAQ under the ticker IPSC, and a successful IND clearance would be the most material near-term catalyst for its stock, setting up the 2027 first-in-human readout as the next value inflection point. The programme is also watched as a test of whether iPSC manufacturing platforms can achieve the batch-to-batch reproducibility that regulators require at scale, a question that applies across the broader iPSC cell therapy field.