Zelluna Receives Positive MHRA Feedback and Strengthens UK Clinical Strategy for ZI-MA4-1 Paving the Way for First-in-Human Trials in the UK

On track to file CTA by year end 2025, with plan to dose first patients and deliver initial data in 2026Planned UK trial to be led by Prof. Fiona Thistlethwaite at The Christie NHS Foundation Trust, a European hub for advanced therapies, with participation from Dr. Andrew Furness at The Royal Marsden, a world-renowned centre for oncology and early-phase clinical research Oslo, Norway, 9 October 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic (“off-the-shelf”) T Cell...

Oslo, 09/10/2025 (informazione.news - comunicati stampa - salute e benessere)

Oslo, Norway, 9 October 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic (“off-the-shelf”) T Cell Receptor-based Natural Killer (TCR-NK) cells for the treatment of cancer, today announced it has received positive feedback from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) following recent scientific advice. This feedback provides alignment on the preclinical, manufacturing, clinical and regulatory pathway for ZI-MA4-1 and supports Zelluna’s planned Clinical Trial Application (CTA) submission later this year.

In parallel, Zelluna has advanced preparations for the first-in-human trial of ZI-MA4-1 by engaging with leading UK cancer centres and appointing Professor Fiona Thistlethwaite, Medical Oncology Consultant at The Christie in Manchester, as proposed Chief Investigator. The Christie, one of Europe’s leading cancer centres and a major hub for advanced cell therapy research, will serve as a lead site for the study. Both Professor Fiona Thistlethwaite at The Christie and Dr. Andrew Furness at The Royal Marsden in London, a global leader in oncology and early-phase cell therapy studies, are expected to play central roles in the trial and have contributed to shaping its design and development strategy.

Subject to CTA approval, the proposed Phase I trial will be an open-label, dose-escalation basket study evaluating the safety, tolerability and preliminary efficacy of ZI-MA4-1 across multiple solid tumours.

Prof. Fiona Thistlethwaite, Medical Oncology Consultant within the Experimental Cancer Medicines Team (ECMT), Clinical Lead for the Advanced Immunotherapy and Cell Therapy (AICT) Team, The Christie, and proposed Chief Investigator for the planned trial, said “

Zelluna Immunotherapy (OSE: ZLNA) is a biotechnology company pioneering the development of allogeneic ‘off-the-shelf’ T Cell Receptor-based Natural Killer (TCR-NK) cells for the treatment of cancer. The company’s platform combines the innate killing power of NK cells with the precision targeting of TCRs, designed to address the limitations of current cell therapies, particularly in solid tumours. Zelluna’s proprietary manufacturing process enables scalable, cost-effective production of TCR-NK cell therapies, with potential for broad patient accessibility. The company’s lead program, ZI-MA4-1, targets the MAGE-A4 tumour antigen and is expected to enter clinical trials in 2026. Zelluna is headquartered in Oslo, Norway.

Namir Hassan, CEO, Zelluna ASA

Email: namir.hassan@zelluna.com

Phone: +44 7720 687608

Hans Vassgård Eid, CFO, Zelluna ASA

Email: hans.eid@zelluna.com

Phone: +47 482 48632

For media enquiries, please contact:

Frazer Hall/Mark Swallow – MEDiSTRAVA

Email: zelluna@medistrava.com