Zelluna Receives UK MHRA and Ethics Approval to Initiate ZIMA-101 First-in-Human Clinical Trial

• Regulatory clearance enables start of clinical testing and marks transition to clinical-stage company
• On track for initial clinical data to emerge from mid-2026

Oslo, Norway, 20 February 2026 – Zelluna (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC) has approved the Company's Clinical Trial Application (CTA) for ZIMA-101, a first-in-human Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna's lead TCR-NK product candidate.

Highlights:

• MHRA and Ethics approvals enable Zelluna to initiate first-in-human clinical trial in the UK
• Marks Zelluna's transition from preclinical to clinical-stage development
• First clinical evaluation of Zelluna's proprietary TCR-NK platform technology
• Trial to assess safety and preliminary activity in patients with advanced solid cancers
• Initial clinical data expected to emerge from mid-2026
  
  
  
  

The approvals allow Zelluna to initiate the ZIMA-101 study in the United Kingdom, marking a key milestone in the Company's transition from preclinical to clinical-stage development and representing the first clinical evaluation of its proprietary TCR-NK platform.

ZIMA-101 is designed to assess the safety, tolerability, and preliminary clinical activity of ZI-MA4-1 in patients with advanced solid cancers, including lung cancer, ovarian cancer, head and neck cancer, and sarcomas.

"The MHRA and Ethics Committee approvals represent a significant milestone for Zelluna and reflects the strength of the work the team has delivered across science, manufacturing, and regulatory execution," said Namir Hassan, CEO of Zelluna ASA. "Importantly, this first-in-human study is designed not only to evaluate ZI-MA4-1 as a product candidate, but also to generate critical clinical insight into the broader potential of our TCR-NK platform. We now move into an important phase of clinical execution and learning for Zelluna as we initiate our first clinical programme and begin to generate clinical insights into the broader potential of our TCR-NK platform”

ZI-MA4-1 is an off-the-shelf cell therapy that combines two powerful cancer fighting mechanisms: the precise solid tumour targeting of T cell receptors (TCRs) with the potent and broad cancer killing ability of Natural Killer (NK) cells. This approach is designed to address key limitations that have prevented existing cell therapies from working effectively in solid tumours. ZI-MA4-1 targets MAGE-A4, a protein found in many solid cancers including lung, ovarian, head and neck and sarcomas.

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

The UK MHRA offers a well-established regulatory framework for advanced therapies, including early-phase clinical development of Advanced Therapy Medicinal Products (ATMPs), providing an efficient and supportive environment for pioneering modalities such as TCR-NK therapies.

About the ZIMA-101 trial:

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.

“I am delighted that the ZIMA-101 study has received MHRA approval. This is an important step that brings us close to opening the study to patient recruitment.’ 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. “ZI-MA4-1 combines the broad tumour-recognition and innate cytotoxic capacity of NK cells with a tumour-specific TCR which I am optimistic will provide potent anti-tumour activity while minimising the risk of tumour escape.”

The Company expects clinical data to emerge from mid-2026.

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:

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 Joachim Midttun, Finance manager of Zelluna ASA, on 20 February 2026 at 14.30 CET.