On December 12, 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, reported 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.
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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.
"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 needs."
ZI-MA4-1 is the world’s first MAGE-A4-targeting TCR-NK therapy, designed to harness both the innate cancer-killing properties of NK cells and the precision targeting of affinity-enhanced TCRs. The therapy aims to overcome key challenges facing current cell therapies in solid tumours, including tumour heterogeneity and antigen loss, while offering an anticipated favourable safety profile and broad patient access.
"As we approach CTA submission, this achievement represents the final operational step on our path to the clinic," said Namir Hassan, CEO of Zelluna. "Together with our compelling preclinical data showing ZI-MA4-1’s potent and selective activity in solid tumour models, this milestone underscores the strength of our science, our process, and our team. We believe ZI-MA4-1 is a highly differentiated therapy with the potential to redefine what is possible for patients with solid tumours. This is a proud and energising moment for everyone at Zelluna."
Zelluna remains on track to submit a CTA for ZI-MA4-1 in 2H 2025 with initial clinical data expected mid-2026.
(Press release, Zelluna Immunotherapy, DEC 12, 2025, View Source [SID1234664035])