Zelluna receives positive MHRA feedback for ZI-MA4-1, advancing UK clinical strategy

Zelluna announced positive feedback from the UK's MHRA regarding its lead candidate, ZI-MA4-1, confirming alignment on the preclinical, manufacturing, clinical, and regulatory pathway. This feedback supports the planned Clinical Trial Application (CTA) submission later this year, targeting first patient dosing and initial data in 2026.

The company has solidified its UK clinical strategy, appointing professor Fiona Thistlethwaite of The Christie NHS Foundation Trust as proposed chief investigator. The Christie, a European hub for advanced therapies, will lead the study, with participation from Dr. Andrew Furness at The Royal Marsden, a global leader in oncology and early-phase clinical research.

The proposed Phase I trial for ZI-MA4-1 will be an open-label, dose-escalation basket study, evaluating safety, tolerability, and preliminary efficacy across multiple solid tumours. This progress is a significant step for Zelluna's TCR-NK cell therapy, designed for scalable and accessible treatment of solid tumours.