IMUNON, Inc. announced on February 19, 2025, new translational data from ongoing analyses of its Phase 2 OVATION 2 Study of IMNN-001 in newly diagnosed advanced ovarian cancer. The results demonstrated a 20% increase in IL-12 levels in women treated with the 100 mg/m² dose of IMNN-001 compared to the 79 mg/m² dose.
These data confirmed a dose-dependent mechanism, with increases in IL-12, interferon-gamma (IFN-γ), and tumor necrosis factor-alpha (TNF-α) observed primarily in the peritoneal fluid cavity, the tumor microenvironment. Little to no changes were detected in the systemic bloodstream, indicating a localized effect.
The study continued to show a favorable safety profile for IMNN-001, with no reports of serious immune-related adverse events. This translational evidence reinforces the scientific understanding of IMNN-001's mechanism of action and supports its advancement into a Phase 3 pivotal trial, which remains on track to start in the first quarter of 2025.
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