Zelluna completes key manufacturing milestone for cancer therapy

Zelluna (OSE: ZLNA) today announced the successful manufacture and quality control (QC) testing of the first Good Manufacturing Practice (GMP) batch of its lead candidate, ZI-MA4-1. This material is intended for Zelluna's upcoming first-in-human clinical trial, marking a significant step towards regulatory submission and patient dosing. The company remains on track to file a Clinical Trial Application (CTA) by year-end 2025, with initial clinical data anticipated mid-2026.

The GMP batch was produced using Zelluna's proprietary manufacturing process, finalized in April 2025, designed to generate hundreds of doses from a single run, offering broad patient access and cost efficiencies. ZI-MA4-1 is the world's first MAGE-A4-targeting TCR-NK therapy, designed to address challenges in solid tumors while providing a favorable safety profile.

This manufacturing success represents the final operational step before clinical trials, according to chief executive Namir Hassan. The company highlights its compelling preclinical data, which demonstrates ZI-MA4-1's potent and selective activity in solid tumor models.