Announcement • Jul 14
Zelluna ASA Doses First Solid Tumour Patient with ZI-MA4-1 in the ZIMA-101 Phase 1 trial Zelluna ASA announced that the first patient has been given the first dose in ZIMA-101, the Company’s first-in-human Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna’s lead TCR-NK product candidate. The first patient was treated at The Christie NHS Foundation Trust in the United Kingdom, the largest single site cancer centre in Europe and the lead clinical site for the study. ZIMA-101 is evaluating ZI-MA4-1, the world's first MAGE-A4-targeting TCR-NK cell therapy to enter clinical development, in patients with advanced MAGE-A4-positive solid tumours. MAGE-A4 is present in several common cancer types, including ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer. ZIMA-101 also represents the first clinical evaluation of Zelluna's proprietary TCR-NK platform and builds on years of scientific innovation, preclinical research and manufacturing development. The study is now active at two clinical sites in the United Kingdom: The Christie and The Royal Marsden NHS Foundation Trusts. Patient identification, pre-screening and screening activities continue across all four tumour indications included in the ZIMA-101 study. Zelluna expects initial clinical data from the ZIMA-101 study to emerge from mid-2026. ZIMA-101 is a first-in-human, multicentre Phase 1 dose-escalation study evaluating the safety, tolerability and preliminary anti-tumour activity of ZI-MA4-1 in patients with advanced MAGE-A4-positive solid tumours. The study is being conducted at The Christie and The Royal Marsden NHS Foundation Trusts in the United Kingdom. The study follows a dose escalation design (3+3) with three predefined dose levels and three patients per dose level. Each patient will receive three doses on Days 1, 4 and 8 of a treatment cycle. For the first patient at each dose level, an Independent Data Monitoring Committee will review the patient's data following completion of the initial safety observation period before providing recommendations on enrolment of the remaining two patients at that dose level. ZI-MA4-1 is Zelluna's lead allogeneic (off the shelf) TCR-NK product candidate and the world's first MAGE-A4-targeting TCR-NK cell therapy in clinical development. The product combines the innate tumour-killing properties of NK cells with precision tumour targeting enabled by affinity engineered T cell receptors (TCRs), with the goal of addressing key limitations of existing cell therapies in solid tumours, including scalability, tumour targeting and access. Announcement • Jun 29
Zelluna Activates Second Clinical Site For ZIMA-101 Phase 1 Clinical Trial Evaluating ZI-MA4-1 Zelluna announced that The Royal Marsden NHS Foundation Trust has been activated as the second clinical site in the ZIMA-101 Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna's lead TCR-NK product candidate. The activation of this second clinical site further expands the Company's clinical execution capabilities and patient recruitment capacity as ZIMA-101 progresses through its early stages. The site will soon be in a position to actively identify and screen patients with suitable tumour types, characteristics (including expression of the MAGE-A4 antigen and HLA-A*02 positivity) and disease stage for potential enrolment. The activation of The Royal Marsden follows the activation of the first clinical site, The Christie NHS Foundation Trust. With both sites now activated, the ZIMA-101 programme has full clinical execution capability across two of the UK's leading cancer centres. ZIMA-101 is a first-in-human Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna's lead TCR-NK product candidate and the world's first MAGE-A4-targeting TCR-NK therapy in clinical development. The study marks the first clinical evaluation of Zelluna's proprietary TCR-NK platform. Zelluna remains on track for initial clinical data from the ZIMA-101 study to emerge from mid-2026. Announcement • Jun 27
Zelluna Reports Final Readout From Legacy Ultimovacs DOVACC Phase II Trial For UV1 Cancer Vaccine Zelluna announced that the NSGO-CTU sponsored Phase II DOVACC clinical trial (NCT04742075) investigating the Ultimovacs UV1 cancer vaccine, inherited through the business combination between the two companies in 2025, did not meet the primary endpoint. The investigator-led Phase II DOVACC study evaluating UV1 in BRCAwt platinum sensitive recurrent ovarian cancer did not meet its primary endpoint of progression free survival (PFS). The DOVACC readout represents the final Phase II outcome for the UV1 programme; all five Phase II studies evaluating UV1 did not meet their primary endpoints. Aside from minimal costs associated with completing the remaining study close-out activities, Zelluna does not expect to incur any further material costs related to the UV1 programme which is now considered concluded. The DOVACC trial tested the cancer vaccine UV1 in patients with BRCAwt platinum sensitive recurrent ovarian cancer. The goal was to assess whether UV1, given alongside two established cancer medicines, could slow disease progression better than standard treatment alone. The DOVACC readout represents the fifth Phase II study evaluating UV1 that has not met its primary endpoint. 
