Zelluna Reaches Major Milestone with Manufacturing Process Established in Preparation for Clinical Entry of ZI-MA4-1, its Novel TCR-NK Therapy Targeting Solid Tumours

Oslo, Norway, 22 April 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, has successfully developed, scaled and automated its proprietary manufacturing process for its TCR-NK cell therapies. This milestone represents a major advancement in the Company’s preparation for clinical entry to provide life-changing, innovative treatments for patients battling cancer. The proprietary manufacturing process is applicable to any product emerging from the Company’s pipeline which means any TCR-NK product can be plugged into the established manufacturing process strengthening Zelluna’s dominance of the TCR-NK therapeutic field.

Establishing and locking down a manufacturing process marks an essential step towards the production of TCR-NK cell therapies for clinical development and future commercialization. Based on the established manufacturing process, hundreds of doses could be produced from a single manufacturing batch highlighting scalability and low cost of goods potential. Zelluna continues to advance its lead TCR-NK cell therapy candidate ZI-MA4-1 in preparation for a filing in the second half of 2025 to begin clinical development targeting a variety of solid tumours.

Zelluna has partnered with Catalent, a leading global contract development and manufacturing organization (CDMO), for process development and manufacturing. Catalent brings significant experience in cell therapy manufacturing in compliance with the highest quality standards.

Emilie Gauthy, Head of CMC at Zelluna, commented: “Today marks an important milestone for Zelluna and a crucial step in the development of our novel off the shelf TCR-NK therapies, giving us the potential to make them widely accessible for patients. For any cell therapy, the complexities and challenges of manufacturing are well known and so establishing an efficient process represents a significant achievement.  I am therefore incredibly proud of what our team together with our CDMO partners have achieved in transforming a groundbreaking concept from the laboratory into a tangible lead product ready for clinical development that can potentially benefit a wide cross-section of cancer patients.”

The established process has delivered its first TCR-NK cell therapy product in the form of Zelluna’s lead asset ZI-MA4-1 targeted at solid tumours, with high standards of purity, potency, and safety, designed to meet the needs of patients while also adhering to the latest regulatory requirements. ZI-MA4-1 has shown promising results in preclinical studies, demonstrating the potential of TCR-NK cells to effectively target and eliminate diverse cancer types, in ways that can overcome cancer escape, and with an anticipated favorable safety profile compared to benchmarked cell-based immunotherapies. The company is now well-positioned to move forward with clinical trials and bring this groundbreaking therapy closer to patients.

"We are thrilled to have successfully locked down our TCR-NK cell therapy manufacturing process," said Namir Hassan, CEO of Zelluna. "This pivotal achievement not only demonstrates our capability to produce high-quality, scalable TCR-NK cell therapies, but also underscores our commitment to advancing next-generation immunotherapies that could transform the treatment of solid tumours and improve patient outcomes. This accomplishment is a testament to the exceptional talent and relentless drive of our team and partners."

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Namir Hassan, CEO, Zelluna ASA

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Hans Vassgård Eid, CFO, Zelluna ASA

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About Zelluna ASA

Zelluna’s mission is to deliver transformative treatments with the capacity to cure advanced solid cancers, in a safe and cost-efficient manner, to patients on a global scale. The Company aims to do this by combining the most powerful elements of the immune system through pioneering the development of “off the shelf” T cell receptor (TCR) guided natural killer (NK) cell therapies (TCR-NK). The TCR-NK platform offers a unique mechanism of action with broad cancer detection capability to overcome the diversity of tumours and will be used “off the shelf” to overcome scaling limitations of current cell therapies. The lead program is a world’s first MAGE-A4 targeting “off the shelf” TCR-NK for the treatment of various solid cancers; a pipeline of earlier products follows. The Company is led by a management team of biotech entrepreneurs with deep experience in discovery through to clinical development of TCR and cell-based therapies including marketed products.

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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 Hans Vassgård Eid, CFO of Zelluna ASA, on 22 April 2025 at 07.45 CET.