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.”