Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 46

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 2
Chunk 46
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 rate for these
therapies is 10% to 20% with median overall survival (“OS”) of 11 to 12 months. 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 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