(RTTNews) - Zelluna ASA (ZLNA) a clinical-stage company, said that the Independent Data Monitoring Committee (IDMC) has recommended continuing patient enrollment in the Phase 1 ZIMA-101 trial following a review of safety data from the first patient.
ZIMA-101 is a Phase 1 study evaluating the safety, tolerability and preliminary anti-tumor activity of ZI-MA4-1 in patients with advanced solid tumors expressing MAGE-A4. The trial uses a stepwise dose-escalation approach, with three patients planned at each dose level and an independent safety review after the first patient.
ZI-MA4-1 is Zelluna's lead allogeneic T Cell Receptor - based Natural Killer (TCR-NK) cell therapy targeting MAGE-A4. The investigational, off-the-shelf therapy combines the tumor-killing properties of NK cells with T-cell receptor-based targeting of MAGE-A4, which is expressed in several cancers, including ovarian cancer, lung cancer, synovial sarcoma and head and neck cancer.
Zelluna said the first patient has completed all three planned doses of ZI-MA4-1 on Days 1, 4 and 8, with no serious adverse events or dose-limiting toxicities observed. Thus, the IDMC has recommended enrollment of two additional patients at the same first dose level.
Additionally, patient screening and recruitment are ongoing at The Christie and The Royal Marsden NHS Foundation Trusts in the U.K. The company expects additional safety and clinical data as enrollment progresses.
Zelluna shares have traded between 8.20 Norwegian Krone and 35.80 Norwegian krone over the last year.
In Oslo, Zelluna shares closed Tuesday up 7.14% at NOK 22.50.