• Positive Opinion from EMA PDCO on CYP-001 PIP
• PIP involves Phase 2/3 trial in ~72 aGvHD patients aged 28 days to 18 years
• Phase 3 trial in adults planned first, followed by paediatric trial

Cynata Therapeutics Limited, a clinical-stage biotechnology company, has received a Positive Opinion from the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) on the Paediatric Investigation Plan (PIP) for CYP-001 in acute graft versus host disease (aGvHD). The PDCO has agreed to Cynata's proposed PIP, which will involve a single randomised controlled Phase 2/3 clinical trial of CYP-001 in approximately 72 aGvHD patients aged from 28 days to 18 years. The company plans to commence a Phase 3 clinical trial in adults initially. After completion of the primary analysis of the adult Phase 3 trial, Cynata plans to commence the paediatric clinical trial. CYP-001 is Cynata's Cymerus iPSC-derived MSC product for intravenous use, designed to modulate the immune system and improve both response rates and survival outcomes in aGvHD.