ZI-MA4-1 / Zelluna, UT MD Anderson Cancer Center - LARVOL DELTA

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 (The Manila Times) - "This feedback provides alignment on the preclinical, manufacturing, clinical and regulatory pathway for ZI-MA4-1 and supports Zelluna’s planned Clinical Trial Application (CTA) submission later this year...'we are building strong momentum towards initiating a UK-based trial that could generate the first safety and efficacy data in 2026.'..Subject to CTA approval, the proposed Phase I trial will be an open-label, dose-escalation basket study evaluating the safety, tolerability and preliminary efficacy of ZI-MA4-1 across multiple solid tumours."

New P1 trial • Solid Tumor

Zelluna Q1 2025 slides highlight TCR-NK manufacturing breakthrough post-merger (Investing.com) - "The first quarter of 2025 was transformative for Zelluna, marked by the completion of its business combination with Ultimovacs ASA on March 3, 2025, accompanied by a private placement of MNOK 51.7...Zelluna’s pipeline consists of three main programs: ZI-MA4-1 targeting MAGE-A4, ZI-KL1-1 targeting KK-LC-1, and ZI-PR-1 targeting PRAME...Zelluna provided an update on the MultiClick Technology and UV1 Program inherited from Ultimovacs....two remaining trials, LUNGVAC and DOVACC, have completed enrollment with topline results expected during 2025....Zelluna outlined several key upcoming milestones that could serve as value inflection points. In the second half of 2025, the company expects to complete preclinical work, begin GMP manufacturing, and submit IND/CTA applications. Initial clinical readouts are anticipated in the first half of 2026."

Clinical data • M&A • Cervical Cancer • Gastric Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer • Sarcoma • Synovial Sarcoma

Development of the first optimised 'off the shelf' MAGE-A4 targeting TCR-NK cells for advancement into the clinic for the treatment of solid tumors (SITC 2024) - "Ethics Approval All ethical approval was obtained for this work. Use of human material was provided by the Regionale Komiteer for Medisinsk og helsefaglig forskningsetikk – REK:231235."

IO biomarker • Oncology • Solid Tumor • CD8 • MAGEA4 • TGFB1

Development of the first optimised "off the shelf" MAGE-A4 targeting TCR-NK cells for advancement into the clinic for the treatment of solid tumors (AACR 2024) - "Interestingly, we observe enhanced proliferation of ZI-MA4-1a cells after activation by MAGE-A4 expressing tumor cells, indicating that TCR-NK cells acquire further proliferative capacity when the TCR is triggered. Finally, we demonstrate higher activity of ZI-MA4-1a compared to KVL-a and benchmark TCR transduced T cells against antigen positive targets, and activity against antigen negative tumor cells escaping TCR-T cell recognition."

IO biomarker • Oncology • Solid Tumor • CD8 • MAGEA4

A novel ‘off the shelf’ TCR-NK cell therapy platform for the treatment of solid tumours: development of optimised MAGE-A4 targeting TCR-NK cells for advancement into the clinic (SITC 2023) - "Conclusions Taken together, these data demonstrate the feasibility and potential of generating optimised TCR-NK cells from PB-NK resulting in a highly potent cell product combining TCR-mediated and innate NK killing functions. Based on the potency and safety profile, ZI-MA4–1 has advanced into manufacturing with a preclinical package underway to enable a clinical trial for treatment of patients with advanced solid tumours."

IO biomarker • Oncology • Solid Tumor • CD8 • MAGEA4