Company: IMNN
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022120
Chunk: 18

Company: Imunon, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 18
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 Additionally,
10% to 15% of ovarian cancer cases nationwide are a result of germline or somatic BRCA mutations. With cognizance of tumor genetics,
practice has shifted to include targeted agents in ovarian cancer treatment.

Poly
(ADP-ribose) polymerase (“PARP”) enzymes are responsible for detecting and repairing single-stranded and double-stranded
DNA breaks during cell replication. BRCA1/2 mutations hinder the homologous recombination repair pathway, and tumor cells utilize PARP
enzymes to repair DNA. For this reason, these tumors are particularly sensitive to the mechanism of PARP inhibitors. PARP inhibitors
have expanded treatment options in ovarian cancer in maintenance following front-line treatment, but few treatment options are left for
women who are not eligible to receive PARP inhibitors and no product has ever demonstrated an OS improvement in the front-line treatment
of newly diagnosed patients with ovarian cancer.

Immunotherapy
is an attractive, novel approach for the treatment of ovarian cancer particularly since ovarian cancers are considered immunogenic tumors.
Interleukin-12 (“IL-12”) is one of the most active cytokines for the induction of potent anti-cancer immunity acting through
the induction of T-lymphocyte and 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 administration of
an IL-12 encoded DNA plasmid formulated with our proprietary TheraPlas delivery system. In the clinical development program, the
immunotherapy treatment schedule follows frontline standard of care and 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;

    ●