Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 26

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 1
Chunk 26
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) 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) 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 ADP-ribose polymerase (PARP) inhibitors
as part of standard maintenance therapy. The primary endpoint of the study is overall survival (OS), and secondary endpoints are surgical
response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several
exploratory endpoints.

IMNN-001
in Combination with bevacizumab. In February 2023, the Company and Break Through Cancer, a public foundation dedicated to