Century Therapeutics Unveils CNTY-813 iPSC-Derived Islet Replacement Preclinical Data at ADA 2026: Demonstrates Durable Glucose Control, Immune Evasion, and Scalable Manufacturing, IND Filing Expected Q4 2026

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Overview

Century Therapeutics presented new preclinical data for its iPSC-derived islet replacement therapy, CNTY-813, at the ADA 2026 Scientific Sessions. The data demonstrated durable glucose control, immune evasion under alloimmune pressure, and scalable manufacturing capabilities. The company has established its manufacturing process for Phase 1 clinical trials, proven consistent product quality, and anticipates filing an Investigational New Drug (IND) application in Q4 2026. This achievement opens new prospects for iPSC-based diabetes treatment.

In Depth

Key Findings

Century Therapeutics unveiled groundbreaking preclinical data for CNTY-813, its iPSC (induced pluripotent stem cell)-derived islet replacement therapy candidate, at the American Diabetes Association (ADA) 2026 Scientific Sessions. The data definitively demonstrated CNTY-813’s ability to maintain durable glucose control even under alloimmune pressure, along with robust immune evasion properties and scalable manufacturing capabilities. The company plans to file an Investigational New Drug (IND) application for a Phase 1 clinical trial in Q4 2026.

Technical / Clinical Details

• CNTY-813 Characteristics: CNTY-813 is an iPSC-derived islet-like cell therapy aiming to restore insulin-producing function through transplantation. Due to its iPSC origin, it offers an unlimited cell supply, and advanced gene editing allows for immune evasion properties, reducing rejection risks in allogeneic transplantation.
• Preclinical Data Highlights:
  • Durable Glucose Control: Preclinical studies in animal models confirmed CNTY-813’s ability to consistently maintain blood glucose levels within the normal range, suggesting potential to reduce or eliminate lifelong insulin injections.
  • Immune Evasion Under Alloimmune Pressure: Alloimmune responses are a major cause of transplant rejection. CNTY-813 demonstrated evasion from alloimmune pressure, achieved by suppressing HLA Class I and II expression or expressing immunosuppressive molecules through gene editing. This significantly boosts its feasibility as an “off-the-shelf” product.
  • Scalable Manufacturing Capability: The manufacturing process for Phase 1 clinical trials has been successfully established and demonstrated consistent product quality, outlining a path for future commercial large-scale supply and cost optimization.
• IND Application Plan: Based on these promising preclinical data, Century Therapeutics plans to submit an IND application for CNTY-813 in Q4 2026, marking a critical milestone for a new diabetes treatment option.

Background & Context

Patients with Type 1 and severe Type 2 diabetes often require lifelong insulin injections or islet transplantation. However, islet transplantation faces challenges like donor scarcity and lifelong immunosuppression. iPSC-derived islet cells offer potential solutions, especially “off-the-shelf” products with immune evasion, which could eliminate donor dependency and dramatically improve treatment accessibility. Century Therapeutics’ achievements represent the cutting edge of R&D in this field.

Strategic Significance & Outlook

The IND filing and subsequent initiation of clinical trials for CNTY-813 signify the potential for iPSC-derived cell therapy to profoundly change diabetes treatment. The preclinical demonstration of durable glucose control, immune evasion, and scalable manufacturing enhances the probability of success for this therapeutic. In the future, CNTY-813 is expected to become a groundbreaking therapy that dramatically improves the quality of life for diabetes patients, potentially freeing them from insulin injections.