PHILADELPHIA, PA — Century Therapeutics (Nasdaq: IPSC) reported new preclinical data supporting its experimental type 1 diabetes therapy CNTY-813, as the biotechnology company works toward a planned Investigational New Drug application submission in the fourth quarter of 2026.
The data, presented at the American Diabetes Association’s 86th Scientific Sessions in New Orleans, showed the company’s induced pluripotent stem cell-derived islet replacement therapy maintained glucose control for more than eight months in preclinical models and demonstrated resistance to immune rejection without the use of immunosuppressive drugs.
The findings are significant because current islet cell transplantation approaches can restore insulin production in some patients with type 1 diabetes but typically require lifelong immunosuppression, limiting broader adoption.
CNTY-813 combines laboratory-produced islet cells with Century’s proprietary Allo-Evasion 5.0 immune-evasion technology, which is designed to prevent rejection by the recipient’s immune system.
“These preclinical data advance our case for a potentially functional cure for type 1 diabetes,” Chief Executive Officer Brent Pfeiffenberger said. He added that the company has completed development of its Phase 1 manufacturing process and remains on track for an IND submission in late 2026.
According to the company, diabetic mice treated with CNTY-813 rapidly achieved normal blood glucose levels and maintained glucose control for more than eight months following transplantation. The study also found that immune-evasion modifications did not impair the cells’ glucose-regulating function.
Century reported no evidence of tumor formation or abnormal tissue growth in more than 140 mice monitored for more than three months after receiving a combined total of more than one billion infused cells.
Additional laboratory testing showed the therapy resisted multiple forms of immune attack, including responses from T cells, natural killer cells, and antibody-mediated pathways.
In a humanized mouse model designed to simulate allogeneic immune rejection, CNTY-813 maintained normal C-peptide secretion and glucose tolerance through 42 days after transplantation. Unmodified islet grafts, by contrast, experienced rapid functional decline and rejection, according to the company.
Century also reported that its Phase 1 clinical manufacturing process produced consistent results across multiple large-scale production runs, meeting predefined purity and cell composition specifications while maintaining potency after cryopreservation.
The company plans to submit its IND application for CNTY-813 in the fourth quarter of 2026, pending completion of remaining preclinical studies. Initial safety and efficacy data from a first-in-human clinical trial are expected during the second half of 2027.
Type 1 diabetes affects an estimated nine million people worldwide. Century is developing CNTY-813 as a potential off-the-shelf cell therapy intended to eliminate the need for both chronic immunosuppression and external insulin therapy.
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