Announcement • Jun 09
Century Therapeutics Presents New Preclinical Data for CNTY-813 Islet Replacement Therapy At ADA 2026
Century Therapeutics, Inc. presented new preclinical data from CNTY-813, Century’s iPSC-derived islet replacement therapy engineered with Allo-Evasion™ 5.0, in an oral presentation at the American Diabetes Association 86th Scientific Sessions in New Orleans, Louisiana. CNTY-813 is designed to address the need for chronic immunosuppression directly: a potential off-the-shelf, iPSC-derived islet replacement therapy engineered with Allo-Evasion™ 5.0 to eliminate the need for immunosuppression and exogenous insulin. Based on preclinical data to date, Century believes CNTY-813 has the potential to deliver what no prior therapy has achieved, a functional cure for T1D without the need for chronic immunosuppression. The presentation, titled “CNTY-813: Scalable Production of Allo-Evasion™ 5.0-Engineered iPSC Beta Islets for Off-the-Shelf Cell Therapies” (Abstract 1318-OR), was delivered at 2:45 p.m. CT. The data highlight CNTY-813’s demonstrated functional potency, scalable manufacturing, engraftment with no evidence of abnormal outgrowth or tumorigenesis, and ability to maintain glucose control under allogeneic immune pressure, a combination of properties that Century believes distinguishes CNTY-813 as a completely novel approach to islet cell replacement. CNTY-813 iPSC-derived islet cells rapidly restored normoglycemia in streptozotocin-rendered diabetic mice and maintained glucose control for greater than eight months following transplantation. New data demonstrate that Allo-Evasion™ 5.0-edited cells showed comparable glucose control to non-edited cells, confirming the immune evasion engineering modifications do not affect the islets’ ability to control glucose. Islet performance in a glucose tolerance test demonstrated glucose normalization within 60 minutes in both edited and unedited islets. New single-cell RNA sequencing analysis demonstrated that CNTY-813 contains a consistent and optimal ratio of differentiated cell types in islet clusters, with beta cells comprising greater than 50% of total cell composition. Greater than 98% of cells were identified in G1 phase, indicating cell cycle exit on par with primary islets. In vivo graft analysis at two, four, and eight weeks post-infusion confirmed endocrine graft morphology was maintained with no evidence of cyst formation or abnormal outgrowth, as assessed by Ki67 staining over time. No tumorigenesis was observed in more than 140 mice with more than three months of follow-up across one billion cells infused. Additional data from multiple in vitro assays demonstrated that CNTY-813 cells containing Allo-Evasion™ 5.0 edits provided significant protection from natural killer (NK) cell clearance, induced rapid IgG cleavage of a surrogate anti-drug antibody, and demonstrated protection from antibody-mediated phagocytosis. These results confirm functional activity across all three engineered immune protection layers: T cells, NK cells, and humoral evasion. New data from a humanized mouse allogeneic graft rejection model engrafted with healthy donor peripheral blood mononuclear cells (PBMCs) to support survival of functional human T cells without graft-versus-host disease and human NK cells, demonstrated that mice transplanted with CNTY-813 maintained normal C-peptide secretion function through 42 days post-transplant. In contrast, mice transplanted with unedited islet grafts showed rapid functional deterioration and allo-rejection with PBMC co-engraftment. Consistent with immune evasion, Allo-Evasion™ 5.0-engineered islets maintained glucose tolerance in a glucose tolerance test under allogeneic immune pressure while unedited islets showed reduced function. Century has established its manufacturing processes for Phase 1 clinical trial supply. New data demonstrated consistent product quality across three separate at-scale experiments from Century’s GMP Master Cell Bank, comprising 11 samples, with optimal endocrine purity, islet cell content, and minimal islet cell impurities across all samples. The 29-day, bioreactor-based suspension differentiation process met pre-defined purity specifications at each stage. The process supports cryopreservation with retained post-thaw potency. Century expects to submit an Investigational New Drug application for CNTY-813 in the Fourth Quarter of 2026, subject to completion of remaining IND-enabling studies. Initial safety and early efficacy data from the first-in-human CNTY-813 study are anticipated in the second half of 2027. CNTY-813 is engineered with Allo-Evasion™ 5.0, Century’s proprietary immune evasion technology, which is designed to enable durable engraftment without chronic systemic immunosuppression, the central unresolved limitation of every currently approved or late-stage cell therapy approach to T1D. Preclinical data demonstrated robust glucose-responsive function, favorable pre-clinical safety profile, scalable and reproducible manufacturing, and immune protection under alloimmune pressure. Century is targeting an IND submission for CNTY-813 in the Fourth Quarter of 2026.
