Zelluna Reaches Major Milestone and Submits Clinical Trial Application in the UK for First-in-Human Study of ZI-MA4-1 (ZIMA-101), the World’s First MAGE-A4-Targeting TCR-NK Cell Therapy for Solid Tumours

• On track for initial clinical data in mid-2026
• Marks a pivotal step toward scalable, accessible, off-the-shelf cell therapies for solid tumours

Oslo, Norway, 17 December 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic off-the-shelf cell therapies for cancer, today announced the submission of its Clinical Trial Application (CTA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for ZI-MA4-1, the Company’s lead candidate.

The CTA submission marks Zelluna’s transition from preclinical to clinical development and represents the successful delivery of all key milestones communicated for 2025:

• Manufacturing process locked (April 2025)
• Preclinical data package completed and key data published (December 2025)
• GMP clinical batch produced and quality-tested (December 2025)
• Clinical Trial Application submitted to the UK MHRA (December 2025)

ZI-MA4-1 is a novel cell therapy that combines two powerful cancer fighting mechanisms: precise solid tumour targeting of T cell receptors (TCRs) with the potent and broad cancer killing ability of Natural Killer (NK) cells. ZI-MA4-1 targets MAGE-A4, a protein found in many solid cancers including lung, ovarian, head and neck and sarcomas.  

“Submitting our first CTA is a transformational moment for Zelluna,” said Namir Hassan, Chief Executive Officer of Zelluna. “ZI-MA4-1 will be the first MAGE-A4-targeting TCR-NK cell therapy to enter clinical testing globally and represents the culmination of rigorous scientific, non-clinical, CMC and regulatory work. Reaching this major milestone is a testament to the unwavering dedication and talent of the Zelluna team past and present, the guidance of our board, and the commitment of our investors. I am immensely proud of our team for delivering on the commitments we set out to achieve this year. We now enter the most important phase of our journey – demonstrating the potential of TCR-NK therapies for solid cancer patients.”

Zelluna’s CTA submission comes as off-the-shelf cell therapies are gaining significant traction across industry and investors, reflecting a broader shift toward scalable, accessible cell therapy solutions.  

The UK MHRA was selected for its strong track record in advanced therapy approvals and its collaborative early-phase regulatory pathways, providing an efficient and supportive environment for pioneering modalities such as TCR-NK therapies.

About the ZIMA-101 trial: 

The Phase I clinical trial will evaluate ZI-MA4-1 in patients with advanced solid tumours including ovarian cancer, head-and-neck cancer, squamous non-small-cell lung cancer, and synovial sarcoma. The study will assess safety, tolerability and early signs of efficacy with initial data expected mid-2026 (subject to regulatory approval).

The trial will be led by Prof. Fiona Thistlethwaite at The Christie NHS Foundation Trust (Manchester, UK) with participation from Dr. Andrew Furness at The Royal Marsden (London, UK), both world leading centres for oncology and early-phase cell therapy clinical research.

“This is an exciting moment, the submission of the CTA is a huge step towards bringing the ZIMA-101 study into the clinic, ” said Prof. Thistlethwaite, Medical Oncology Consultant within the Experimental Cancer Medicines Team, Clinical Lead for the Advanced Immunotherapy and Cell Therapy Team, The Christie, and Chief Investigator for the ZIMA-101 trial. “I am optimistic that combining the broad tumour-recognition and innate killing activity of NK cells with a tumour antigen directed TCR will provide us with the step-change that we need in the solid tumour setting to provide the required level of tumour potency whilst avoiding tumour escape.”

ZI-MA4-1 has broad intellectual property coverage, including a landmark granted patent providing dominant protection for Zelluna over the entire TCR-NK field.

About Zelluna ASA

Zelluna ASA (OSE: ZLNA) is a pioneering allogeneic ‘off-the-shelf’ T Cell Receptor-based Natural Killer (TCR-NK) cells for the treatment of solid cancers. The company’s platform combines the innate killing power of NK cells with precise  solid tumour targeting of TCRs, designed to address the limitations of current cell therapies in solid tumours. The company’s lead candidate, ZI-MA4-1, is the worlds-first MAGE-A4 targeting TCR-NK therapy expected to enter clinical trials in 2026. Zelluna is headquartered at the Oslo Cancer Cluster innovation Park in Oslo, Norway and is listed on the Oslo Stock Exchange under the ticker ZLNA.

For further information, please contact:

Namir Hassan, CEO, Zelluna ASA

Email:

Phone:

Anders Tuv, Chairman, Zelluna ASA

Email:

Phone: +47 982 06 826

International media:

Frazer Hall/Mark Swallow – MEDiSTRAVA

Email:

This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act.

This stock exchange announcement was published by Geir Christian Melen, Finance Director of Zelluna ASA, on 17 December 2025 at 17.23 CET.