Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 48

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 2
Chunk 48
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Nγ) 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 in tumor naïve
    CD8+ cell population to more efficient tumor killing memory effector CD8+ cells.

On
July 29, 2021, the Company announced final PFS results from the OVATION 1 Study published in the Journal of Clinical Cancer Research.
Median PFS in patients treated per protocol (n=14) was 21 months and was 18.4 months for the ITT population (n=18) for all dose cohorts,
including three patients who dropped out of the study after 13 days or less, and two patients who did not receive full NACT and IMNN-001
cycles. Under the current standard of care, in women with Stage III/IV ovarian cancer undergoing NACT, their disease progresses within
about 12 months on average. The results from the OVATION 1 Study supported continued evaluation of IMNN-001 based on promising tumor
response, as reported in the PFS data, and the ability for surgeons to completely remove visible tumors at the time of interval debulking
surgery. IMNN-001 was well tolerated,