Century Therapeutics CNTY-813 (Allo-Evasion 5.0 iPSC islets)

Type 1 diabetes destroys the insulin-producing islet cells in the pancreas. You can put new ones in — islet transplantation has demonstrated the potential to restore insulin independence. The unsolved part is keeping them alive. Transplanted islets face two separate attacks: ordinary transplant rejection, because the cells came from someone else, and the original autoimmunity that caused the disease in the first place. Today holding both off requires chronic systemic immunosuppression.

Century Therapeutics' CNTY-813 is an attempt to delete that trade-off: islet cells grown from induced pluripotent stem cells (iPSCs) — an unlimited, off-the-shelf supply — and gene-edited so the immune system cannot see them.²

How it works. The edits are Century's Allo-Evasion 5.0, pitched at three arms of the immune system: T cells, NK cells, and humoral (antibody-mediated) immunity — the last via mechanisms Century describes as rapid IgG cleavage and protection from antibody-mediated phagocytosis.² Century's stated goal is "durable glycemic control without the need for systemic immunosuppression".⁵ That is the right goal. It is also, at present, only a goal.

What has actually been shown — in mice. At the ADA 86th Scientific Sessions in June 2026 and in updated oral presentations at EASD 2026 (2 October 2026) and the Breakthrough T1D Clinical & Research Congress (9 October 2026), Century reported that CNTY-813 islets rapidly restored normal blood glucose in streptozotocin-diabetic mice and held normoglycemia for more than 11 months until graft removal (extended from more than eight months at ADA), normalising glucose within 60 minutes on a tolerance test.²¹ In a humanised mouse model carrying human PBMCs and NK cells — a model built to apply real alloimmune pressure — the edited cells evaded rejection with no immunosuppression, and, importantly, the editing did not degrade their glucose control relative to unedited cells.²¹ On safety, no tumour formation was seen in more than 140 mice followed for over three months across a billion cells infused, which is the central preclinical worry for any iPSC-derived product.² At EASD 2026, Century also reported five clinical-scale manufacturing runs producing high-purity functional islets, successful portal-vein engraftment in rodent feasibility studies, and completed FDA pre-IND alignment.¹

That is a good preclinical package. It is a preclinical package.

What has not been shown. No human being has ever received CNTY-813. As of 19 October 2026 Century has completed FDA pre-IND alignment and is completing final GLP toxicology studies, but has not yet submitted an IND; the company guides to filing one in Q4 2026, with first clinical data in 2H 2027.³¹ No CNTY-813 trial is registered on ClinicalTrials.gov.⁶ Century's own pipeline chart still places CNTY-813 before Phase 1.⁵ Anyone describing this therapy as "in the clinic" is describing something that has not happened.

The autoimmunity question. Century's immune-evasion data is generated under alloimmune pressure — the rejection response against foreign tissue. That is the attack a humanised PBMC/NK model tests. It is not the attack that gave the recipient type 1 diabetes. In principle, editing away the molecules that display a cell's identity should blank the target for both attacks; in practice, no Century data published to date demonstrates protection from returning autoimmunity, and it would be a mistake to assume the alloimmune result carries over. That unresolved risk is the single biggest thing standing between this programme and the word "cure".

How to place it. As of October 2026, exactly one person on earth has transplanted insulin-producing cells surviving with zero immunosuppression: the single recipient in Sana's UP421 study, reported in the New England Journal of Medicine.⁷ That is the entire body of human evidence for drug-free islet transplantation, worldwide, and it is n=1. Century has none of it. Its drug-free claim rests on rodents.

What makes CNTY-813 matter anyway is the state of the field around it. The list of credible, well-funded, near-clinic attempts at islets that survive without anti-rejection drugs is very short — and CNTY-813, backed by $217 million and a runway into 2029, is on it.³ It is the next real shot on goal. It has simply not taken the shot yet, and the honest summary in October 2026 is: promising mice (>11 months of normoglycemia), five clinical-scale manufacturing runs, completed FDA pre-IND alignment, an IND that has not yet been filed, and a first human dose still ahead.