Patient Enrolment Completed in Phase 2 aGvHD Clinical Trial

Core Insights - Cynata Therapeutics Limited has completed patient enrolment in its Phase 2 clinical trial of CYP-001 for high-risk acute graft versus host disease (aGvHD) [2][4] - The trial enrolled 65 participants across clinical centres in the US, Europe, and Australia, with results expected in June 2026 [3][8] - CYP-001 aims to address the significant unmet need for effective treatments in aGvHD, a condition affecting up to 50% of bone marrow transplant patients [5][6] Company Overview - Cynata Therapeutics is a clinical-stage biotechnology company focused on cell therapeutics, utilizing its proprietary Cymerus™ technology for the production of mesenchymal stem cells (MSCs) [8][9] - The company has received Orphan Drug Designation from the US FDA for CYP-001, which qualifies it for various incentives [12] Clinical Trial Details - The Phase 2 trial involves a 100-day primary evaluation period, with the primary endpoint being the Overall Response Rate at Day 28 [3][4] - In a previous Phase 1 trial, CYP-001 demonstrated an 87% Overall Response Rate and a 60% two-year survival rate in steroid-resistant aGvHD patients, with no serious adverse events reported [6][10] Market Context - aGvHD is a serious complication of bone marrow transplantation, with standard steroid treatments failing in approximately 50% of cases, highlighting the need for new therapies [5][6] - Historical survival rates for patients with steroid-resistant aGvHD are less than 20% over two years, underscoring the critical demand for effective treatment options [5]