Century Therapeutics presents non‑clinical data for CNTY‑813 and outlines IND timeline
Century Therapeutics showed new pre‑clinical results for CNTY‑813, its iPSC‑derived islet replacement therapy for type‑1 diabetes, at the European Association for the Study of Diabetes conference in Milan. The data demonstrated sustained normoglycemia in diabetic mice for more than eleven months, consistent product across five clinical‑scale batches, successful liver engraftment in rats and stability after 96 hours of cold storage. The company said it remains on track to file an IND in the fourth quarter of 2026 and expects first‑in‑human safety and early‑efficacy data in the second half of 2027.
Why it matters
The IND filing timeline sets expectations for when the therapy could enter clinical trials, which may affect Century’s cash‑burn profile and investor sentiment. The company’s forward‑looking statements indicate that achieving the IND milestone is critical to advancing its pipeline and could influence the valuation of IPSC.
Key facts
- 1The non‑clinical study lasted over eleven months and showed normoglycemia until graft removal in streptozotocin‑induced diabetic mice. globenewswire.com
- 2Five clinical‑scale batches produced from the GMP Master Cell Bank met consistency and purity criteria across a 29‑day manufacturing process. globenewswire.com
- 3In rats, CNTY‑813 islets engrafted in the liver one month after portal‑vein delivery and stained positive for chromogranin A and insulin. globenewswire.com
- 4Clinical‑scale product remained functional after 96 hours of cold storage, normalizing blood glucose within 30 days and maintaining control for three months. globenewswire.com
- 5Century expects to submit an IND for CNTY‑813 in Q4 2026, subject to completing remaining IND‑enabling studies. sec.gov
- 6Initial safety and early‑efficacy data from the first‑in‑human study are anticipated in the second half of 2027. sec.gov
Summary written by AlphAI from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.