Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 105

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 105
---

natural killer cell proliferation. The precedence for the therapeutic role of IL-12 in ovarian cancer is based on epidemiologic and clinical
and preclinical data.

IMNN-001 Immunotherapy

IMNN-001 is a DNA-based immunotherapeutic drug candidate
for the localized treatment of ovarian cancer by intraperitoneally administering an IL-12 plasmid formulated with our proprietary TheraPlas
delivery system. In this DNA-based approach, the immunotherapy is combined with a standard chemotherapy drug, which can potentially achieve
better clinical outcomes than with chemotherapy alone. We believe that increases in IL-12 concentrations at tumor sites for several days
after a single administration could create a potent immune environment against tumor activity and that a direct killing of the tumor with
concomitant use of cytotoxic chemotherapy could result in a more robust and durable antitumor response than chemotherapy alone. We believe
the rationale for local therapy with IMNN-001 is based on the following:

    ●
    Loco-regional production of the potent cytokine IL-12 avoids toxicities and poor pharmacokinetics associated with 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