Century Therapeutics discloses CNTY-813 preclinical data

Century Therapeutics, Inc. (NASDAQ: IPSC) filed an 8-K to disclose preclinical research data for CNTY-813, an investigational induced pluripotent stem cell (iPSC)-derived islet cell therapy intended for the treatment of type 1 diabetes. The disclosure, attributed to G. Grant Welstead, PhD, Senior Vice President and Head of Research, details the development of the company's Allo-Evasion 5.0 platform, which aims to address supply constraints and the need for chronic immunosuppression associated with traditional islet transplantation.

The presentation outlines a scalable manufacturing process for CNTY-813 that utilizes a 29-day defined differentiation pathway. Century states that this process achieves high purity and reproducibility across batches, surpassing necessary purity criteria at every stage of development. Single-cell RNA sequencing data indicates that the resulting islets contain defined, terminally differentiated endocrine cell populations. Beta cells represent 66.3% of the total population, followed by FEV+ islet cells at 26.4%, alpha cells at 5.5%, delta cells at 0.8%, and exocrine or ductal cells at 1.0%.

Century reports that the CNTY-813 islets demonstrate glucose-responsive insulin secretion and in vivo glucose control in diabetic mice. The company notes that no safety events, specifically tumor formation, have been observed to date in preclinical models. The Allo-Evasion 5.0 engineering is designed to provide T cell protection, NK cell protection, and reduced humoral immune clearance, facilitating an off-the-shelf cell therapy approach.

The filing includes standard forward-looking statements regarding the company's clinical development plans, timelines, and the initial safety and efficacy profiles of CNTY-813. Century identifies several risks that could cause actual results to differ from projections, including the ability to advance product candidates through preclinical studies and clinical trials, the timing of regulatory filings and approvals, and reliance on collaborative relationships for manufacturing. The company notes that it does not plan to publicly update these forward-looking statements except as required by applicable law.