Century Therapeutics CNTY-813 (Allo-Evasion 5.0 iPSC islets)
Century Therapeutics
The next real shot at drug-free islets — still entirely in mice.
What it is
Off-the-shelf insulin-producing islet cells grown from iPSCs and gene-edited with Century's "Allo-Evasion 5.0" to hide from T cells, NK cells and antibodies — the goal being a transplant that needs no anti-rejection drugs. Everything shown so far is in mice. No human has received it: Century is guiding to an IND filing in Q4 2026 and first clinical data in 2H 2027.
Editorial review: .
Most recent recorded citation dates: 2026-07-15; 2026-07-15. Some dates overlap at their stated precision or share the same date. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Preclinical evidence. Benefit in people has not been established.
- Benefit or performance
- Efficacy: In streptozotocin-diabetic mice, CNTY-813 islets restored normoglycemia and held glucose control for more than eight months, normalising glucose within 60 minutes on a tolerance test — genuinely strong rodent efficacy. But this criterion asks whether the approach restores regulated insulin production in people, and CNTY-813 has never been given to a person. A mouse result is not a human result.[1]
- Important harms and treatment burden
- Safety: No tumorigenesis was seen in more than 140 mice followed over three months across a billion cells infused — a meaningful preclinical tumour signal for an iPSC product, where teratoma risk is the classic worry. But there is zero human safety exposure, and multi-layer immune-evasion editing carries the same theoretical costs as every hypoimmune platform: cells hidden from the immune system are also hidden from the surveillance that polices infection and cancer.[1]
- Approval and country access
- IND guided for Q4 2026 and first clinical data for 2H 2027; nothing is enrollable and nothing is approvedApproval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Durability: Eight-plus months of maintained normoglycemia in diabetic mice is a good rodent durability signal, and edited cells performed comparably to unedited ones. It is still mice, on a mouse lifespan, under alloimmune rather than autoimmune pressure. Nothing here speaks to whether a graft survives years in a human with active T1D.[1]
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. This speculative assessment includes intended performance or preclinical findings; it does not establish benefit in people.
Default calculation: 28 × 20 + 55 × 20 + 24 × 20 + 45 × 16 + 30 × 12 + 55 × 12 = 3880; divide by total weight 100. Unrounded weighted result: 38.8.
In streptozotocin-diabetic mice, CNTY-813 islets restored normoglycemia and held glucose control for more than eight months, normalising glucose within 60 minutes on a tolerance test — genuinely strong rodent efficacy. But this criterion asks whether the approach restores regulated insulin production in people, and CNTY-813 has never been given to a person. A mouse result is not a human result.[1]
Designed to need no chronic anti-rejection drugs, and the design has teeth: in a humanised mouse model carrying human PBMCs and NK cells, edited islets evaded rejection with no immunosuppression, and the edits did not blunt glucose control. That earns real credit over drug-dependent cell therapies like zimislecel. It scores well below Sana's 75 for one reason: Sana has human drug-free evidence and Century has none. A mouse is not a person, and an intention is not an achievement. Note too that the demonstration is against *alloimmune* pressure — the returning autoimmunity that destroyed the person's own islets in the first place remains unaddressed by any published Century data.[1]
Pre-IND. The IND-enabling work is real and advanced — GMP master cell bank complete and a Phase 1 manufacturing process established — but as of 15 July 2026 no IND has been submitted, no CNTY-813 trial is registered, and Century's own pipeline chart still places the programme at "Research". Guidance is an IND in Q4 2026 and first clinical data in 2H 2027.[2]
No tumorigenesis was seen in more than 140 mice followed over three months across a billion cells infused — a meaningful preclinical tumour signal for an iPSC product, where teratoma risk is the classic worry. But there is zero human safety exposure, and multi-layer immune-evasion editing carries the same theoretical costs as every hypoimmune platform: cells hidden from the immune system are also hidden from the surveillance that polices infection and cancer.[1]
Eight-plus months of maintained normoglycemia in diabetic mice is a good rodent durability signal, and edited cells performed comparably to unedited ones. It is still mice, on a mouse lifespan, under alloimmune rather than autoimmune pressure. Nothing here speaks to whether a graft survives years in a human with active T1D.[1]
The construct is the broadly-applicable one: an off-the-shelf iPSC-derived product needing no immunosuppression could in principle reach the general T1D population rather than only those sick enough to justify lifelong anti-rejection drugs. Scored on potential, because there is no trial and therefore no eligibility criteria yet — nobody is enrollable today.[4]
Immunosuppression-free is scored here, as it is for cell replacement and encapsulation — freeing a therapy from lifelong anti-rejection drugs is the central barrier this whole pillar is trying to clear, so an approach that achieves it must be able to earn credit for it. It is scored on evidence, not intent: a platform designed to avoid immunosuppression but never yet tested at a therapeutic dose scores on what it has shown. Approaches that transplant nothing (in-vivo gene therapy, reprogramming) need no anti-rejection drugs by construction, but they still face the original autoimmune attack — that unresolved risk belongs in this score, not hidden by it.
The full picture
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.1
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.1 Century's stated goal is "durable glycemic control without the need for systemic immunosuppression".4 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, Century reported that CNTY-813 islets rapidly restored normal blood glucose in streptozotocin-diabetic mice and held it for more than eight months, normalising glucose within 60 minutes on a tolerance test.1 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.1 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.1 Manufacturing has been scaled to a Phase 1 process, with beta cells making up more than half the final cell composition.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 15 July 2026 Century has not submitted an IND; the company guides to filing one in Q4 2026, with first clinical data in 2H 2027.2 No CNTY-813 trial is registered on ClinicalTrials.gov.5 Century's own pipeline chart still places CNTY-813 at the "Research" stage, before IND-enabling and well before Phase 1.4 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 July 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.6 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.2 It is the next real shot on goal. It has simply not taken the shot yet, and the honest summary in July 2026 is: promising mice, competent manufacturing, an IND that has not been filed, and a first human dose still more than a year out.
Coming soon
ETA · No IND submitted as of July 2026. Century guides to an IND filing in Q4 2026 and first clinical data in 2H 2027 — so the earliest human results are more than a year away, and any approval is many years beyond that.
- →Oral presentation of preclinical data at EASD 2026 (Milan) · 2 October 2026
- →Oral presentation at the Breakthrough T1D Clinical & Research Congress (Philadelphia) · 9 October 2026
- →Submit Investigational New Drug (IND) application for CNTY-813 · Q4 2026 (guided; not yet filed)
- →First-in-human Phase 1 trial and initial clinical data · 2H 2027 (guided)
Sources
- [1]New CNTY-813 Preclinical Data Demonstrate Durable Glucose Control, Immune Evasion Under Alloimmune Pressure, and Scalable Manufacturing at ADA 2026 · Manufacturer · 2026-06-08 — Company release accompanying an oral presentation (Leonardo Velazco-Cruz, PhD) at the ADA 86th Scientific Sessions. Source of the >8-month normoglycemia, 60-minute glucose normalisation, humanised-mouse immune evasion and >140-mouse tumorigenicity figures. A press release describing a conference talk — not peer-reviewed data.
Century Therapeutics. New CNTY-813 preclinical data demonstrate durable glucose control, immune evasion under alloimmune pressure, and scalable manufacturing at ADA 2026. GlobeNewswire (8 June 2026).
- [2]Century Therapeutics Reports First Quarter 2026 Financial Results and Business Updates · Manufacturer · 2026-05-13 — States CNTY-813 "expects to submit an IND in 4Q 2026, subject to completion of remaining studies" with initial clinical data in 2H 2027; reports GMP master cell bank completion, FDA engagement, and $217.0M cash with runway into Q1 2029.
Century Therapeutics. Reports first quarter 2026 financial results and business updates. BioSpace (13 May 2026).
- [3]Century Therapeutics Selected for Oral Presentations of CNTY-813 Preclinical Data at EASD 2026 and Breakthrough T1D Clinical & Research Congress 2026 · Manufacturer · 2026-07-09 — Confirms IND on track for Q4 2026 and initial clinical data in 2H 2027. Oral presentations scheduled for EASD (Milan, 2 Oct 2026) and the Breakthrough T1D Clinical & Research Congress (Philadelphia, 9 Oct 2026).
- [4]Century Therapeutics pipeline — CNTY-813, beta islet cells (Allo-Evasion 5.0) · Manufacturer · 2026-07-15 — Company pipeline chart. As retrieved 15 July 2026 it lists CNTY-813 as "iPSC-derived beta islets engineered with Allo-Evasion 5.0" for type 1 diabetes, at the Research stage — before IND-enabling and Phase 1 — "designed to protect from T cell, NK cell and humoral immune rejection".
Century Therapeutics. Pipeline — CNTY-813, beta islet cells (Allo-Evasion 5.0), type 1 diabetes. Century Therapeutics (retrieved 15 July 2026).
- [5]ClinicalTrials.gov — trials sponsored by Century Therapeutics · Trial registry · 2026-07-15 — Checked 15 July 2026: returns three Century-sponsored studies (CNTY-101 in B-cell malignancies and in autoimmune disease, plus a long-term follow-up study). No CNTY-813 study and no type 1 diabetes study is registered.
ClinicalTrials.gov. Studies sponsored by Century Therapeutics (checked 15 July 2026 — no CNTY-813 study registered).
- [6]Long-Term Survival of Hypoimmune Allogeneic Islets without Immunosuppression (Letter) · Peer-reviewed study · 2026-07-10 — Cited here only as the benchmark: the single UP421 recipient is the one human on record with transplanted insulin-producing cells surviving on no immunosuppression. It is what CNTY-813's drug-free claim is scored against.
Carlsson PO, Hu X, Scholz H, et al. Long-term survival of hypoimmune allogeneic islets without immunosuppression (Letter). New England Journal of Medicine (10 July 2026).