Company: IMNN
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022120
Chunk: 26

Company: Imunon, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 26
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 review of data generated to date, including positive results from the recently completed Phase
    2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant
    chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone in 112 patients with newly diagnosed advanced
    ovarian cancer. Treatment was also generally well tolerated, with no reports of cytokine release syndrome or any other serious immune-related
    adverse events.

    ●
    The
    Company also held a Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the FDA regarding production of IMNN-001 for
    the treatment of women with newly diagnosed advanced ovarian cancer. The goal of the meeting was to seek alignment and agreement
    with the FDA on key CMC topics to support IMNN-001 production for the planned Phase 3 pivotal trial and a potential future new biologic
    license application (BLA) submission. The meeting with the FDA included a review of the Company’s current good manufacturing
    practice (cGMP) clinical-scale and commercial manufacturing process for IMNN-001, conducted at the company’s manufacturing
    facility based in Huntsville, Alabama. The Agency agreed that the Company’s potency assay
    which measures interferon-gamma (IFN-γ) is acceptable for the Phase 3 clinical study and for use in a commercial setting for
    release of drug product. The FDA also agreed with the Company’s strategy to establish comparability of the core components
    of IMNN-001 produced by the Company with product previously produced through an external contract development and manufacturing organization.

The
Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly)
plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard of care (SoC) NACT alone. Study
participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3 or 4) who are eligible for
neoadjuvant therapy, the intent-to-treat (ITT) population, with a sub-group of women positive for homologous recombination deficiency
(HRD) including BRCA1 or BRCA2 mutations. Participants who are HRD positive will receive poly AD