Zelluna ASA (OSE:ZLNA), a Norway-based company pioneering allogeneic ("off-the-shelf") T Cell Receptor-based Natural Killer (TCR-NK) cells for the treatment of cancer, said on Thursday that it has received positive feedback from the UK Medicines and Healthcare products Regulatory Agency (MHRA) on the development pathway for its TCR-NK therapy, ZI-MA4-1.

The guidance provides alignment on preclinical, manufacturing, clinical, and regulatory aspects, supporting the company's plan to submit a Clinical Trial Application (CTA) by the end of 2025.

Following approval, Zelluna intends to initiate a first-in-human Phase I trial in the UK in 2026 to evaluate the safety, tolerability, and preliminary efficacy of ZI-MA4-1 across multiple solid tumours. The open-label, dose-escalation basket study will be led by Professor Fiona Thistlethwaite at The Christie NHS Foundation Trust in Manchester, with participation from Dr Andrew Furness at The Royal Marsden in London.

The Christie and The Royal Marsden -- both leading European centres for oncology and early-phase clinical research -- have contributed to shaping the trial's design and development strategy. Zelluna said that the positive MHRA feedback and strengthened UK partnerships mark an important milestone toward bringing its off-the-shelf TCR-NK platform into clinical evaluation.