Century Therapeutics Announces New Beta Islet Program for Type 1 Diabetes
- Allo-Evasion™ 5.0-engineered iPSC beta islets are designed to overcome immune rejection and provide durable glucose control without chronic immunosuppression
- Compelling preclinical data demonstrate rapid reversal of diabetes and sustained normoglycemia, human C‑peptide production and mature GSIS, supported by scalable bioreactor-based manufacturing
- Investigational New Drug (IND)-enabling studies on track to initiate by year-end 2025; IND submission planned as early as 2026
PHILADELPHIA, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. ((‘Century', NASDAQ:IPSC), a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases and cancer, today announced its first program for Type 1 diabetes (T1D), CNTY-813. The program comprises iPSC-derived beta islets engineered with the company's proprietary Allo-Evasion™ 5.0 technology, designed to protect from T cell, NK cell and humoral immune rejection, with the goal of durable glycemic control without the need for systemic immunosuppression.
"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. "After initiating discovery activities earlier this year, we have now generated compelling preclinical data that underscores the deep potential of this program, including rapid and sustained normalization of glucose in diabetic mouse models, significant glucose‑stimulated insulin secretion with detectable human C‑peptide and engineered resistance to NK cell-mediated killing and antibody‑dependent cellular cytotoxicity. Additionally, our suspension bioreactor process is capable of delivering mature, functional beta islets at scale, which we believe positions us to produce a consistent drug product suitable for broad patient access, if approved by regulatory authorities. Considering the large, underserved T1D patient population, we believe this program has great promise to be a potentially curative new therapy."
"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.
Century has generated in vitro and in vivo preclinical data demonstrating:
- Rapid and sustained glucose control in streptozotocin (STZ)-induced diabetic models following transplantation of iPSC-derived beta islets, including maintenance of normoglycemia and human C-peptide production.
- Significant in vitro function, including glucose-stimulated insulin secretion (GSIS) with stimulation indices consistent with mature beta cell phenotypes.
- Allo-Evasion™ 5.0 enables immune protection with knockout of human leukocyte antigen (HLA) class I and II, expression of CD300a-based pan-NK inhibitory ligand and immunoglobulin-degrading enzyme that reduces antibody-dependent cellular toxicity (ADCC), resulting in preserved cell survival in NK cytotoxicity and ADCC assays.
Century expects to initiate IND-enabling studies by year-end 2025 and plans to submit an IND application to the U.S. Food and Drug Administration (FDA) as early as 2026.
About Type 1 Diabetes (T1D)
T1D affects approximately 9 million people worldwide, including approximately 2 million in the U.S., with a significant subset facing persistent hypoglycemia, glycemic variability, and long-term complications despite exogenous insulin. The current treatment of T1D also places a significant burden on the healthcare system, with approximately $6-8 billion spent on insulin annually in the U.S. A scalable, off-the-shelf, immune-evasion-enabled beta islet therapy could reach broad patient segments and expand access relative to donor-dependent transplantation or device-limited solutions. Century's beta islet program is designed to combine clinical impact with a path to profitable scalability, supporting the potential for long-term value creation.
About Century Therapeutics
Century Therapeutics (NASDAQ:IPSC) is a biotechnology company advancing a pipeline of induced pluripotent stem cell (iPSC)-derived cell therapies with the potential to meaningfully address autoimmune diseases and cancer. The company's therapies are derived from its iPSC cell foundry and leverage its novel immune evasion engineering technology, Allo-Evasion™. Century believes its approach to developing off-the-shelf cell therapies will expand patient access and provide advantages over existing cell therapies which will ultimately advance the course of care. For more information on Century Therapeutics, please visit www.centurytx.com and connect with us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our timing and expectations regarding our preclinical and clinical development programs, including their planned development, therapeutic potential and market opportunity, ongoing and planned regulatory interactions, the achievement of developmental milestones, and corporate strategies are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "should," "expect," "plan," "aim," "seek," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "forecast," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: our ability to successfully advance our current and future product candidates through development activities, preclinical studies, and clinical trials; our ability to meet development milestones on anticipated timelines; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials, which may not be predictive of final results or the results of later-stage clinical trials; our ability to obtain clearance of our future IND or Clinical Trial Application (CTA) submissions and commence and complete clinical trials on expected timelines, or at all; our reliance on the maintenance of certain key collaborative relationships for the manufacturing and development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of geopolitical issues, trade disputes and tariffs, banking instability and inflation on our business and operations, supply chain and labor force; the performance of third parties in connection with the development of our product candidates, including third parties conducting our clinical trials as well as third-party suppliers and manufacturers; our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; our ability to recruit and maintain key members of management and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the "Risk Factors" section of our most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
For More Information:
Century Therapeutics
Douglas Carr
Senior Vice President, Finance
[email protected]
JPA Health
Sarah McCabe
[email protected]
