Century Therapeutics’ CNTY-813 Achieves Over Eight-Month Glucose Control and Immune Evasion
IPSC•CNTY-813 iPSC-derived islet therapy maintained normoglycemia for over eight months in preclinical models and demonstrated immune evasion under allogeneic pressure without immunosuppression. The established Phase 1 manufacturing process achieved consistent endocrine purity and islet content, with an IND submission on track for fourth quarter 2026 and initial data expected in 2027.
1. Preclinical Efficacy and Durability
CNTY-813 iPSC-derived islet cells restored normoglycemia in streptozotocin-rendered diabetic mice and maintained durable glucose control for over eight months. Allo-Evasion™ 5.0 edits preserved insulin secretion and normoglycemia under allogeneic immune pressure without immunosuppression.
2. Scalable Phase 1 Manufacturing
The established Phase 1 clinical manufacturing process delivered consistent endocrine purity and optimal islet cell composition across three at-scale batches. A 29-day bioreactor-based suspension differentiation met predefined purity specifications, supported cryopreservation, and retained post-thaw potency.
3. Immune Evasion Performance
Allo-Evasion™ 5.0-engineered cells demonstrated robust protection in vitro against T cells, NK cells, and antibody-mediated clearance assays. In a humanized mouse allogeneic graft model, edited islets maintained C-peptide secretion and glucose tolerance for 42 days without immunosuppression, while unedited cells underwent rapid rejection.
4. IND Submission and Clinical Timeline
Century is on track to submit an Investigational New Drug application for CNTY-813 in the fourth quarter of 2026. Initial clinical data are expected in the second half of 2027 as the company advances toward its goal of a functional cure for type 1 diabetes.
