Positive DSMB Review in Phase 1/2 Kidney Transplant Trial

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Stock Cynata Therapeutics Ltd (CYP.ASX)
Release Time 4 Dec 2025, 8:56 a.m.
Price Sensitive Yes
 Positive DSMB Review in Phase 1/2 Kidney Transplant Trial
Key Points
  • Independent DSMB review of trial Cohort 1 completed with no safety concerns
  • Demonstrates initial safety and tolerability of Cynata's Cymerus™ MSC therapy (CYP-001) in kidney transplant recipients
  • Phase 1/2 study managed and funded by Leiden University Medical Centre (LUMC), a global leader in kidney transplantation
Full Summary

Cynata Therapeutics Limited has announced that an independent Data and Safety Monitoring Board (DSMB) has completed its planned review of the first cohort of patients treated in the Phase 1/2 NEREID kidney transplant trial. The first cohort of patients each received a single intravenous infusion of CYP-001 (Cynata's Cymerus™ iPSC-derived MSC product candidate) approximately six weeks after receiving a kidney transplant, in addition to standard treatment. The DSMB review found no episodes of kidney transplant rejection and no safety concerns, with no serious adverse events related to CYP-001 and no donor-specific antibodies detected. This successful outcome represents the first step in Cynata's clinical development program of CYP-001 in kidney transplant recipients, with the ultimate aim of establishing CYP-001 treatment as a safe and efficacious alternative to the toxic anti-rejection drugs currently used. The Phase 1/2 NEREID trial is being managed and fully funded by Leiden University Medical Centre (LUMC) in the Netherlands, one of Europe's leading academic hospitals and a global centre of excellence in kidney transplantation and regenerative medicine. Following the positive DSMB review, LUMC plans to progress with Cohort 2 of the trial, involving a further three patients who will receive two infusions of CYP-001 in addition to standard treatment.

Outlook

The successful outcome of the first cohort in Cynata's Phase 1/2 kidney transplant trial represents an important milestone in the clinical development of CYP-001 as a potential safer alternative to existing anti-rejection drugs for kidney transplant recipients. The company is now progressing to the next stage of the trial, which will provide further data on the safety and tolerability of CYP-001 in this patient population.