Business
Zelluna Completes First GMP Batch of ZI-MA4-1, a Novel TCR-NK Cell Therapy, to Treat Patients in Upcoming First-in-Human Trial
On track to file a Clinical Trial Application (CTA) by year end 2025, with initial clinical data expected mid-2026Important step in developing scalable and accessible ‘off-the-shelf’ cell therapy for patients with solid tumours Oslo, Norway, 12 December, 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic “off-the-shelf” T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of cancer, today announced the successful manufacture and QC (Quality Control) testing of
About this update from Zelluna Asa
[{"type":"image","alt":"Zelluna ASA","displaySize":"","headline":null,"caption":"Zelluna ASA","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":106,"url":"https://media.zenfs.com/en/globenewswire.com/a3f855525ffb13acd9e8579786771e69"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/C3Qdgv86SfCXtr_6x5fSRg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE0ODtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/a3f855525ffb13acd9e8579786771e69","width":300,"height":106}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"On track to file a Clinical Trial Application (CTA) by year end 2025, with initial clinical data expected mid-2026","length":114,"tagName":"p"}]},{"val":[{"type":"text","content":"Important step in developing scalable and accessible ‘off-the-shelf’ cell therapy for patients with solid tumours","length":113,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":227,"olType":false},{"type":"text","content":"Oslo, Norway, 12 December, 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic “off-the-shelf” T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of cancer, today announced the successful manufacture and QC (Quality Control) testing of the first GMP (Good Manufacturing Practice) batch of its lead candidate, ZI-MA4-1. This material is intended for use in Zelluna’s upcoming first-in-human clinical trial, marking a major milestone in the company’s progress toward regulatory submission and patient dosing.","length":542,"tagName":"p"},{"type":"text","content":"The GMP batch was successfully produced using Zelluna’s proprietary manufacturing process, which was finalised and locked in April 2025. The process is designed to deliver high-quality TCR-NK products, with the ability to generate hundreds of doses from a single manufacturing run, offering both broad patient access and cost-of-goods advantages.","length":346,"tagName":"p"},{"type":"text","content":"“Having our first GMP batch in storage and ready for our first clinical trial fills us with hope and excitement as we move closer to bringing our TCR-NK therapies to patients,” said Emilie Gauthy, Head of CMC at Zelluna. “This successful GMP run, backed by our robust development data, strengthens our confidence in delivering safe, potent, and consistent therapies at a scale capable of meeting patient’s ne...