Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 107

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 107
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 in tumor naïve
    CD8+ cell population to more efficient tumor killing memory effector CD8+ cells.

On
July 29, 2021, the Company announced final PFS results from the OVATION 1 Study published in the Journal of Clinical Cancer Research.
Median PFS in patients treated per protocol (n=14) was 21 months and was 18.4 months for the ITT population (n=18) for all dose cohorts,
including three patients who dropped out of the study after 13 days or less, and two patients who did not receive full NACT and IMNN-001
cycles. Under the current standard of care, in women with Stage III/IV ovarian cancer undergoing NACT, their disease progresses within
about 12 months on average. The results from the OVATION 1 Study supported continued evaluation of IMNN-001 based on promising tumor
response, as reported in the PFS data, and the ability for surgeons to completely remove visible tumors at the time of interval debulking
surgery. IMNN-001 was well tolerated, and no dose-limiting toxicities were detected in the OVATION 1 Study. Intraperitoneal administration
of IMNN-001 was feasible with broad patient acceptance.

OVATION
2 Study. The Company held an Advisory Board Meeting on September 27, 2017 with clinical investigators and scientific experts
including those from Roswell Park Cancer Institute, Vanderbilt University Medical School, and M.D. Anderson Cancer Center to review and
finalize clinical, translational research and safety data from the OVATION 1 Study to determine the next steps forward for our IMNN-001
immunotherapy program. On November 13, 2017, the Company filed its Phase I/II clinical trial protocol with the FDA for IMNN-001 for the
localized treatment of ovarian cancer. The protocol was designed with a single dose escalation phase to 100 mg/m² to identify a
tolerable dose of IMNN-001 within certain safety parameters while maximizing an immune response. The Phase I portion of the study would
be followed by a continuation at the selected dose in approximately 110 patients randomized Phase II study.

In
the OVATION 2 Study, patients in the IMNN-001 treatment arm would receive IMNN-001 plus chemotherapy pre- and post-interval debulking
surgery (“IDS”). The OVATION 2 Study was designed to include up to 110 patients with Stage III/IV ovarian cancer