Cynata Therapeutics (ASX: $CYP) Phase 2 GvHD Trial Commences

Cynata Therapeutics Limited (ASX: $CYP) has confirmed the treatment of the first patient in its Phase 2 clinical trial of CYP-001 in high-risk acute graft versus host disease (aGvHD). CYP-001, the company's Cymerus™ off-the-shelf iPSC-derived MSC product candidate, has shown promising safety and efficacy results in a Phase 1 clinical trial in steroid-resistant aGvHD. The US FDA has cleared an Investigational New Drug (IND) application for CYP-001 and granted the product Orphan Drug Designation for the treatment of aGvHD.

Executive Commentary on Phase 2 GvHD Trial

The treatment of the first patient in this Phase 2 trial marks a milestone moment in the clinical development journey of CYP-001 for aGVHD. We are continuing to open additional clinical centres, and we anticipate completion of enrolment by the end of this calendar year, with primary results available in the second half of 2025.

Summary of Cynata Therapeutics Phase 2 GvHD Trial

Cynata Therapeutics (ASX: $CYP) has treated the first patient in its Phase 2 clinical trial of CYP-001 for high-risk acute graft versus host disease (aGvHD). The trial aims to enrol approximately 60 patients and is approved to commence in Australia, the USA, and Turkey. The company anticipates completion of enrolment by the end of this calendar year, with primary results available in the second half of 2025. Cynata's Cymerus™ technology has shown promise in addressing a range of diseases, and the Phase 2 trial represents a significant step forward in the company's clinical development journey.