Philadelphia-based Century Therapeutics remains on track to file an IND for CNTY-813 by late 2026, showing promising preclinical results in immune-evasive cell therapy for type 1 diabetes as it prepares for clinical trials and upcoming presentations.
Century Therapeutics said it remains on course to file an investigational new drug application for CNTY-813 in the fourth quarter of 2026 after a recent pre-IND meeting with the US Food and Drug Administration. The company said regulators were broadly aligned with its non-clinical package, manufacturing approach and proposed early-stage trial design for the cell therapy, which is being developed for type 1 diabetes.
The Philadelphia-based group has been trying to position CNTY-813 as a potential functional cure by using induced pluripotent stem cells to create islet replacement cells engineered to evade the immune system. In June, it presented preclinical data at the American Diabetes Association’s annual meeting showing more than eight months of glucose control in animals, immune evasion under allogeneic pressure and manufacturing at clinical scale. Century said the same programme has now been selected for oral presentations at upcoming diabetes congresses in Europe and the US.
The company is also moving ahead with CNTY-308, a CD19-targeted CAR-iT cell therapy designed for B-cell-mediated diseases, and still expects to bring it into the clinic this year. Century ended the quarter with $197.2 million in cash, cash equivalents and investments, which it says should fund operations into the first quarter of 2029. Second-quarter research and development spending fell to $19.6 million from $26.9 million a year earlier, while general and administrative costs declined to $5.8 million from $7.8 million.
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