Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 110

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 110
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The
PFS results, the trial’s primary endpoint, support the OS results with:

    ●
    A
    three-month improvement in PFS compared with standard-of-care alone.

    ●
    A
    hazard ratio in the intent-to-treat population of 0.79, indicating a 27% improvement in delaying progression for the IMNN-001 treatment
    arm.

These
initial results from the OVATION 2 Study were presented in a late-breaking session at the Society
for Immunotherapy of Cancer (SITC) 39th Annual Meeting in November 2024.

On
September 11, 2024, a scientific advisory board was held with DSMB members, principal investigators, and scientific experts to discuss
and seek input on the protocol synopsis for the Phase III trial. A protocol synopsis was submitted along with a briefing document for
review and input at the End-of-Phase II (“EOP2”) meeting with the U.S. Food and Drug Administration focused on the Phase
III study. The EOP2 meeting was conducted in the fourth quarter of 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