Century Therapeutics' CNTY-813 Demonstrates Continued Advancement Toward the Clinic Via Nonclinical Data Presented at EASD 2026
Century reached general alignment with FDA on its nonclinical package, Phase 1 manufacturing process and proposed Phase 1/2 trial design.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Century Therapeutics (IPSC) presented nonclinical CNTY-813 data supporting advancement of its stem-cell-derived islet replacement therapy for type 1 diabetes.
In a study lasting over eleven months, CNTY-813 maintained blood glucose control in diabetic mice until graft removal. All treated diabetic mice achieved normal blood glucose. Five clinical-scale batches produced consistent final product profiles, and the 29-day manufacturing process exceeded purity criteria at every stage. Delivery through the liver portal vein resulted in engraftment in rats at one month. Clinical-scale islets remained functional after 96 hours of cold storage, normalizing blood glucose in mice within 30 days.
Century expects an Investigational New Drug application in Q4 2026, subject to completing remaining enabling studies. Initial human safety and early efficacy data are anticipated in the second half of 2027.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointFDA general alignment covered the nonclinical package, Phase 1 manufacturing process and proposed Phase 1/2 trial design.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Century expects a CNTY-813 Q4 2026 Investigational New Drug application submission.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Initial human safety and early efficacy data are anticipated in the second half of 2027.
- Minor pointCNTY-813 maintained blood glucose control in diabetic mice until graft removal during a study lasting over eleven months.
- Minor pointAll treated diabetic mice achieved normal blood glucose after CNTY-813 administration.
6 minor points
- Minor pointCNTY-813 showed glucose-stimulated insulin secretion potency similar to primary islets.
- Minor pointFive clinical-scale batches produced consistent final product profiles.
- Minor pointThe 29-day manufacturing process exceeded purity criteria at every stage.
- Minor pointLiver portal vein delivery achieved rat liver engraftment at one month, with endocrine and beta-cell identity retained.
- Minor pointIslets stored cold for 96 hours normalized mouse blood glucose within 30 days, maintained through three months.
- Minor pointGlucose tolerance after cold-stored islet transplantation was indistinguishable from normal controls by one month.
Negative
- Minor point. Forward-looking: it has not happened yet and may not happen.The Q4 2026 application submission remains subject to completion of remaining enabling studies.
Key Figures
- Study duration
- Over 11 months
- Diabetic mouse model; glycemic control lasted until graft removal
- Clinical-scale batches
- 5 batches
- Consistent final product profiles
- Manufacturing process
- 29 days
- Purity criteria were exceeded at every stage
- Cold storage
- 96 hours
- Clinical-scale islets remained functional after cold storage
- Blood glucose normalization
- Within 30 days
- Mice transplanted with islets after cold storage
- Follow-up
- 3 months
- Normoglycemia maintained after transplantation
- IND submission
- Q4 2026
- Century said submission remains on track, subject to remaining IND-enabling studies
- Initial clinical data
- Second half of 2027
- Anticipated from the first-in-human CNTY-813 study
Historical Context
-
Prior CNTY-813 data showed glucose control beyond eight months and immune evasion in humanized mice.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
ipsc medical
investigational new drug regulatory
normoglycemia medical
streptozotocin medical
good manufacturing practice technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Data demonstrated scalable production, in vivo function and immune evasion, and updated progress toward clinical dosing of CNTY-813, Century's iPSC-derived islet replacement therapy for type 1 diabetes
CNTY-813 IND submission remains on track for Q4 2026; initial clinical data anticipated in the second half of 2027
PHILADELPHIA, Oct. 02, 2026 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. (“Century”, NASDAQ: IPSC), a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for type 1 diabetes (T1D) and other autoimmune diseases, today announced the presentation of nonclinical data for CNTY-813, Century's iPSC-derived islet replacement therapy engineered with Allo-Evasion™ 5.0. Data were presented in an oral presentation at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan, Italy.
In a study lasting over eleven months, updated data demonstrated CNTY-813 maintained glycemic control in a diabetic mouse model until CNTY-813’s graft removal. New data further highlighted CNTY-813’s anticipated readiness for clinical testing via demonstration of drug product consistency across five clinical-scale runs, glycemic control in a diabetic mouse model after extended drug product cold storage, and successful engraftment of CNTY-813 via the intended clinical route of administration.
“The data presented at EASD build on the nonclinical package we presented at ADA in June and highlight our continued execution on bringing CNTY-813 into the clinic,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. “Following our pre-IND meeting, in which we reached general alignment with FDA on our nonclinical package, Phase 1 manufacturing process and proposed Phase 1/2 trial design, we remain on track to submit the CNTY-813 IND in the fourth quarter of this year with initial clinical data anticipated in the second half of 2027.”
New Nonclinical Data Highlights
Glycemic control sustained until graft removal in diabetic mice
- Allo-Evasion™ 5.0-edited CNTY-813 islets rapidly restored normoglycemia in streptozotocin-induced diabetic mice and maintained glycemic control until graft removal, demonstrating clear pharmacological activity. The study lasted over eleven months.
- All streptozotocin-induced diabetic mice administered with CNTY-813 achieved normoglycemia.
- CNTY-813 islets showed glucose-stimulated insulin secretion potency similar to primary islets.
Phase 1 clinical manufacturing process produced consistent product across five clinical-scale batches
- Five clinical-scale batches from Century's Good Manufacturing Practice Master Cell Bank produced consistent final product profiles.
- The 29-day process exceeded purity criteria at every stage.
Liver portal vein delivery in rats resulted in successful engraftment supporting the planned clinical route of administration
- In rats, CNTY-813 islets were identified engrafted in the liver at one month post-transplant.
- Engrafted islets stained positive for chromogranin A, an endocrine cell marker, and for insulin, confirming they retained islet endocrine and beta cell identity after delivery.
Clinical-scale product remained functional after 96 hours of cold storage, supporting future clinical supply chain
- Mice transplanted with clinical-scale islets after 96 hours of cold storage normalized blood glucose within 30 days and maintained normoglycemia through three months of follow-up.
- By one month post-transplant, glucose tolerance was indistinguishable from normoglycemic controls.
Grant Welstead, Ph.D., Senior Vice President, Head of Research at Century, delivered the presentation, titled “CNTY-813: Scalable Production of Allo-Evasion™ 5.0-Engineered iPSC-Derived Islets for Off-the-Shelf Cell Therapies” (Presentation 225), on Friday, October 2, 2026, in Session OP 39, “Beta cells on demand: stem cells to beta cell therapy,” held from 10:00 to 11:00 a.m. Central European Summer Time in Paris Hall. The presentation is available in the Scientific Resources section of the Science page on Century's website at Events and Presentations | Century Therapeutics.
Upcoming CNTY-813 Milestones
- Investigational New Drug (IND) submission (4Q 2026): 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 clinical data (2H 2027): Initial safety and early efficacy data from the first-in-human CNTY-813 study are anticipated in the second half of 2027.
About Century Therapeutics
Century Therapeutics (NASDAQ: IPSC) is a biotechnology company advancing a pipeline of iPSC-derived cell therapies with the potential to meaningfully address autoimmune diseases, including T1D, and cancer. Century'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 for regulatory submissions, nonclinical and clinical development, including CNTY-813's IND submission and expected data readout in the second half of 2027, and our financial resources and expected cash runway, 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. 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. 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
investor.relations@centurytx.com
Corey Davis, Ph.D.
LifeSci Advisors, LLC
212-915-2577
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Century Therapeutics' CNTY-813 nonclinical study show about blood glucose control?
CNTY-813 maintained blood glucose control until graft removal in diabetic mice during a study lasting over eleven months. All streptozotocin-induced diabetic mice administered CNTY-813 achieved normal blood glucose.
When does Century Therapeutics expect CNTY-813 regulatory submission and initial clinical data?
Century expects to submit the CNTY-813 Investigational New Drug application in Q4 2026, subject to completing remaining enabling studies, with initial clinical data anticipated in the second half of 2027. Those first-in-human data are expected to cover safety and early efficacy.