Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 106

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 106
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 and tumor microenvironment including peritoneal cavity, which is the primary
    site of metastasis of ovarian cancer;

    ●
    Changes
    in local and systemic levels of immuno-stimulatory and immune-suppressive cytokines associated with tumor suppression and growth,
    respectively; and

    ●
    Expression
    profile of a comprehensive panel of immune related genes in pre-treatment and IMNN-001-treated tumor tissue.

During
2016 and 2017, we announced data from the first 14 patients in the OVATION 1 Study. On October 3, 2017, we announced final translational
research and clinical data from the OVATION 1 Study.

Key
translational research findings from all evaluable patients were consistent with the earlier reports from analysis of the data and are
summarized below:

    ●
    The
    intraperitoneal treatment of IMNN-001 in conjunction with standard-of-care neoadjuvant chemotherapy (“NACT”) resulted
    in dose-dependent increases in IL-12 and Interferon-gamma (IFNγ) levels that were predominantly in the peritoneal fluid compartment
    with little to no changes observed in the patients’ systemic circulation. These and other post-treatment changes including
    decreases in VEGF levels in peritoneal fluid were consistent with an IL-12 based immune mechanism;

    ●
    Consistent
    with previous analyses the effects observed in the immunohistochemistry analysis were pronounced decreases in the density of immunosuppressive
    T-cell signals (Foxp3, PD-1, PDL-1, IDO-1) and increases in CD8+ cells in the tumor microenvironment;

    ●
    The
    ratio of CD8+ cells to immunosuppressive cells was increased in approximately 75% of patients, suggesting an overall shift in the
    tumor microenvironment from immunosuppressive to pro-immune stimulatory following treatment with IMNN-001. An increase in CD8+ to
    immunosuppressive T-cell populations was a leading indicator and believed to be a good predictor of improved OS; and

    ●
    Analysis
    of peritoneal fluid by cell sorting, not reported before, showed a treatment-related decrease in the percentage of immunosuppressive
    T-cell (Foxp3+), which was consistent with the reduction of Foxp3+ T-cells in the primary tumor tissue, and a shift