Company: IMNN
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022120
Chunk: 21

Company: Imunon, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 21
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 were detected in the OVATION 1 Study. Intraperitoneal administration
of IMNN-001 was feasible with broad patient acceptance.

19

OVATION
2 Study. The Company held an Advisory Board Meeting on September 27, 2017 with clinical investigators and scientific experts
including those from Roswell Park Cancer Institute, Vanderbilt University Medical School, and M.D. Anderson Cancer Center to review and
finalize clinical, translational research and safety data from the OVATION 1 Study to determine the next steps forward for our IMNN-001
immunotherapy program. On November 13, 2017, the Company filed its Phase I/II clinical trial protocol with the FDA for IMNN-001 for the
localized treatment of ovarian cancer. The protocol was designed with a single dose escalation phase to 100 mg/m² to identify a
tolerable dose of IMNN-001 within certain safety parameters while maximizing an immune response. The Phase I portion of the study would
be followed by a continuation at the selected dose in approximately 110 patients randomized Phase II study.

In
the OVATION 2 Study, patients in the IMNN-001 treatment arm would receive IMNN-001 plus chemotherapy pre- and post-interval debulking
surgery (“IDS”). The OVATION 2 Study was designed to include up to 110 patients with Stage III/IV ovarian cancer, with 15
patients in the Phase I portion and up to 95 patients in Phase II. The sample size is consistent with a Phase II trial designed to inform
the design of a Phase III trial comparing IMNN-001 with neoadjuvant + adjuvant chemotherapy versus neoadjuvant + adjuvant chemotherapy
alone. As a Phase II study, the OVATION 2 Study was not powered for statistical significance. The primary endpoint is PFS and the primary
analysis would be conducted after at least 80 events had been observed or after all patients had been followed for at least 16 months,
whichever was later. Additional endpoints included objective response rate, chemotherapy response score, and surgical response.

On
March 23, 2020, the Company announced that the European Medicines Agency (the “EMA”) Committee for Orphan Medicinal Products
(“COMP”) had recommended that IMNN-001 be designated as an orphan medicinal product for the treatment of ovarian cancer.
IMNN-001 previously received orphan designation from the FDA.

In
February 2021, the Company announced that it had received