Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 111

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 111
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 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 months following treatment with IMNN-001 plus
standard-of-care (SoC) neoadjuvant and adjuvant chemotherapy (NACT) versus SoC alone. More than one-third of patients in the trial survived
more than 36 months from the point of study enrollment, with 62% of those surviving patients from the IMNN-001 treatment arm and 38%
from the SoC arm. Over 10% of trial participants have reached 48 months or beyond. In April 2025, the Company announced that an IMNN-001 abstract was accepted for oral presentation at the 2025 ASCO
annual meeting. The Company also plans to submit the results for publication in
a peer-reviewed medical journal.

In
March 2025, the Company announced that the FDA is aligned with the protocol for the Phase 3 pivotal trial,
called OVATION 3, of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer.
The Company is currently initiating trial sites and working with trial investigators to begin enrolling study participants.

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)