Zelluna Completes First GMP Batch of ZI-MA4-1, a Novel TCR-NK Cell Therapy, to Treat Patients in Upcoming First-in-Human Trial

Core Insights - Zelluna has successfully manufactured and quality controlled the first GMP batch of its lead candidate, ZI-MA4-1, intended for its first-in-human clinical trial, marking a significant milestone in the company's development process [1][4] - The proprietary manufacturing process allows for the generation of hundreds of doses from a single run, enhancing patient access and reducing costs [2][5] - ZI-MA4-1 is the first MAGE-A4-targeting TCR-NK therapy, designed to address challenges in treating solid tumors, including tumor heterogeneity and antigen loss, while maintaining a favorable safety profile [3][4] Company Overview - Zelluna ASA is a biotechnology company focused on developing allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for cancer treatment [5] - The company aims to combine the innate killing power of NK cells with the precision targeting of TCRs to overcome limitations of current therapies, particularly in solid tumors [5] - Zelluna plans to submit a Clinical Trial Application (CTA) for ZI-MA4-1 in the second half of 2025, with initial clinical data expected by mid-2026 [4][6]