Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 52

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 2
Chunk 52
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 2024.

    ●
    The
    positive outcome of the EOP2 in-person meeting with the U.S.
    Food and Drug Administration (FDA), supported the advancement of IMNN-001 for the treatment
    of advanced ovarian cancer into a Phase 3 pivotal study. The interaction with the FDA included an extensive 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.

17

    ●
    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.

In
December 2024, the Company announced additional clinical data from ongoing analyses of results from the Phase 2 OVATION 2 Study. The
updated results, based on an additional seven months of patient monitoring, showed the hazard ratio (HR) decreased from 0.74 to 0.69
in the ITT population, with an increase in median overall survival (OS) from 11.1 to 13