Zelluna Receives Positive MHRA Feedback and Strengthens UK Clinical Strategy for ZI-MA4-1 Paving the Way for First-in-Human Trials in the UK

Core Insights - Zelluna has received positive feedback from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) regarding its ZI-MA4-1 program, which is a significant step towards clinical trials [1][3] - The company is preparing for its first-in-human trial of ZI-MA4-1, with The Christie in Manchester as the lead site and Professor Fiona Thistlethwaite as the proposed Chief Investigator [2][6] - The planned Phase I trial will be an open-label, dose-escalation study focusing on the safety, tolerability, and preliminary efficacy of ZI-MA4-1 across multiple solid tumors, with initial data expected in 2026 [3][5] Company Overview - Zelluna Immunotherapy specializes in developing allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cells for cancer treatment, aiming to overcome limitations of current therapies, especially for solid tumors [5] - The company's lead program, ZI-MA4-1, targets the MAGE-A4 tumor antigen and is anticipated to enter clinical trials in 2026 [5][6] - Zelluna's proprietary manufacturing process allows for scalable and cost-effective production of TCR-NK cell therapies, enhancing patient accessibility [5]