Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 104

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 104
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 Most women with ovarian cancer are not diagnosed until Stages III or IV, when the disease
has spread outside the pelvis to the abdomen and areas beyond, causing swelling and pain. With the five-year survival rates for Stages
III and IV at 41% and 20%, respectively, there remains a need for a therapy that not only reduces the recurrence rate but also meaningfully
improves overall survival. Patients whose cancer recurs or progresses after initially responding to surgery and first-line chemotherapy
have been divided into one of the two groups based on the time from completion of platinum therapy to disease recurrence or progression.
This time period is referred to as platinum-free interval. The platinum-sensitive group has a platinum-free interval of longer than six
months. This group generally responds to additional treatment with platinum-based therapies. The platinum resistant group has a platinum-free
interval of shorter than six months and is resistant to additional platinum-based treatments. Pegylated liposomal doxorubicin, topotecan,
and bevacizumab are the only approved second-line therapies for platinum-resistant ovarian cancer. The overall response 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