Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 47

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 2
Chunk 47
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 systemic delivery of recombinant IL-12;

    ●
    Persistent local delivery of IL-12 lasts up to one week and dosing can be repeated; and

    ●
    Local therapy is ideal for long-term maintenance therapy.

OVATION 1 Study. In February 2015, we
announced that the FDA accepted the Phase I dose-escalation clinical trial of IMNN-001 in combination with the standard of care in neoadjuvant
ovarian cancer (the “OVATION 1 Study”). The OVATION 1 Study was designed to:

    ●
    identify a tolerable and therapeutically active dose of IMNN-001 within certain safety parameters by recruiting and maximizing an immune response;

    ●
    enroll three to six patients per dose level and evaluate safety and efficacy; and

    ●
    attempt to define an optimal dose for a follow-on Phase I/II study.

15

In
addition, the OVATION 1 Study established a unique opportunity to assess how cytokine-based compounds such as IMNN-001 directly affect
ovarian cancer cells and the tumor microenvironment in newly diagnosed ovarian cancer patients. The study was designed to characterize
the nature of the immune response triggered by IMNN-001 at various levels of the patients’ immune system, including:

    ●
    Infiltration
    of cancer fighting T-cell lymphocytes into primary tumor 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 (IF