Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 51

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 2
Chunk 51
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 DSMB members, principal investigators, and scientific experts was held to review efficacy
and safety data from the OVATION 2 study.

On
July 30, 2024, the Company announced positive topline results from the Phase II OVATION 2 Study. Highlights from patients treated with
IMNN-001 plus standard-of-care in a first-line treatment setting include:

    ●
    An
    11.1 month increase in median OS compared with standard-of-care alone in the ITT population.

    ●
    A
    hazard ratio in the ITT population of 0.74, which indicates a 35% improvement in survival.

    ●
    Among
    the approximately 90% of trial participants who received at least 20% of specified treatments per-protocol in both study arms, patients
    in the IMNN-001 arm had a 15.7 month increase in median OS, representing a further extension of life with a hazard ratio of 0.64,
    a 56% improvement in survival.

    ●
    For
    nearly 40% of trial participants treated with a PARP inhibitor, the hazard ratio decreased further to 0.41, with median OS in the
    IMNN-001 treatment arm not yet reached at the time of database lock, compared with median OS of 37.1 months in the standard-of-care
    treatment arm.

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