Century Therapeutics Unveils Immune-Evasive iPSC Beta Islet Therapy for Type 1 Diabetes
Key Insights
Century Therapeutics announced CNTY-813 (search), an iPSC-derived beta islet therapy engineered with Allo-Evasion™ 5.0 technology designed to provide durable glucose control without chronic immunosuppression for Type 1 diabetes (search) patients.
Preclinical data demonstrate rapid reversal of diabetes and sustained normoglycemia in diabetic mouse models, with significant glucose-stimulated insulin secretion and detectable human C-peptide production.
The company plans to initiate IND-enabling studies by year-end 2025 and submit an IND application to the FDA as early as 2026 for this potentially curative therapy.
Century Therapeutics has announced its first Type 1 diabetes (search) program, CNTY-813 (search), featuring iPSC-derived beta islets engineered with the company's proprietary Allo-Evasion™ 5.0 technology. The therapy is designed to overcome immune rejection and provide durable glucose control without the need for chronic immunosuppression, potentially representing a paradigm shift in Type 1 diabetes treatment.
Breakthrough Immune Evasion Technology
The Allo-Evasion™ 5.0 platform incorporates multiple immune protection mechanisms, including knockout of human leukocyte antigen (HLA) class I and II, expression of CD300a (search)-based pan-NK inhibitory ligand, and an immunoglobulin-degrading enzyme that reduces antibody-dependent cellular cytotoxicity (ADCC). These modifications result in preserved cell survival in NK cytotoxicity and ADCC assays, addressing the fundamental challenge of immune rejection that has limited previous beta islet therapies.
"With our cell foundry and Allo-Evasion™ 5.0 technology, we have engineered iPSC derived beta islets that we believe can deliver durable glycemic control without chronic immunosuppression," said Chad Cowan, Ph.D., Chief Scientific Officer of Century Therapeutics.
Compelling Preclinical Results
Century's preclinical data demonstrate several key therapeutic achievements. In streptozotocin (STZ)-induced diabetic models, the iPSC-derived beta islets showed rapid and sustained glucose control following transplantation, including maintenance of normoglycemia and human C-peptide production. The therapy also exhibited significant in vitro function, with glucose-stimulated insulin secretion (GSIS) showing stimulation indices consistent with mature beta cell phenotypes.
The company's suspension bioreactor process enables scalable manufacturing of mature, functional beta islets, positioning the therapy for broad patient access if approved by regulatory authorities.
Clinical Development Timeline
Century expects to initiate IND-enabling studies by year-end 2025 and plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration as early as 2026. This timeline reflects the company's confidence in the preclinical data and manufacturing capabilities developed through its iPSC cell foundry platform.
Addressing Significant Unmet Medical Need
Type 1 diabetes (search) affects approximately 9 million people worldwide, including approximately 2 million in the U.S. A significant subset of patients face persistent hypoglycemia, glycemic variability, and long-term complications despite exogenous insulin therapy. The current treatment paradigm places a substantial burden on the healthcare system, with approximately $6-8 billion spent on insulin annually in the U.S.
"Today, people with T1D struggle with unpredictable glucose swings, the burden of lifelong insulin, and diabetes related complications. An off-the-shelf, immune-evasive beta islet therapy that restores physiologic insulin production without systemic immunosuppression would represent a paradigm shift," said James Markmann, M.D., Ph.D., Vice President for Transplantation Services, Perelman School of Medicine, University of Pennsylvania.
Scalable Manufacturing Advantage
Century's approach offers potential advantages over existing cell therapies and donor-dependent transplantation solutions. The scalable, off-the-shelf nature of the iPSC-derived therapy could expand access relative to current treatment options, while the immune evasion technology eliminates the need for chronic immunosuppression that typically accompanies transplantation approaches.
The beta islet program is designed to combine clinical impact with a path to profitable scalability, supporting the potential for long-term value creation in addressing this large, underserved patient population.