Cynata Completes Patient Enrolment in Phase 2 aGvHD Clinical Trial

Patient enrolment completed in Cynata Therapeutics' Phase 2 clinical trial of CYP-001 for adults with newly diagnosed, high-risk acute graft versus host disease (aGvHD).

A total of 65 participants enrolled across clinical centers in the US, Europe, and Australia, randomized to receive steroids plus CYP-001 or steroids plus placebo.123

Primary evaluation period (100 days) expected to conclude in March 2026, with results anticipated around June 2026; primary endpoint is Overall Response Rate at Day 28.1

CYP-001, derived from Cynata's Cymerus™ iPSC technology, showed promising Phase 1 results:
87% overall response, 53% complete response, 60% two-year survival, no serious adverse events related to treatment.1

Announcement made on December 14, 2025, by Cynata Therapeutics (ASX:
CYP), highlighting unmet need for safer aGvHD treatments.1

Sources:

1. https://www.prnewswire.com/news-releases/patient-enrolment-completed-in-phase-2-agvhd-clinical-trial-302641748.html

2. https://www.investing.com/news/company-news/cynata-completes-enrollment-in-phase-2-acute-graft-versus-host-disease-trial-93CH-4407129

3. https://vir.com.vn/patient-enrolment-completed-in-phase-2-agvhd-trial-142892.html