IMUNON Announces First Patient Dosed in Phase 3 OVATION 3 Study of IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer

Initiation of additional trial sites and patient enrollment activities ongoing with multiple patients in screening

LAWRENCEVILLE, N.J., July 30, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, today announced that the first patient has been dosed in the pivotal Phase 3 OVATION 3 Study evaluating the Company’s lead candidate, IMNN-001, for the treatment of women with newly diagnosed advanced ovarian cancer. The first patient was dosed by Melanie K. Bergman, M.D., FACOG, Gynecologic Oncologist with Providence Medical Group at Providence Health in Spokane, Washington.

“IMNN-001 represents a potentially transformative therapy that, in combination with standard of care chemotherapy, may make a meaningful difference in the lives of women facing a new devastating diagnosis of advanced ovarian cancer,” said Dr. Bergman. “IMNN-001 has shown significant therapeutic potential in clinical trials thus far, including consistent overall survival benefit across multiple treatment groups. We are pleased to be involved in the Phase 3 study and support its clinical development to further validate its safety and efficacy for women who currently have no effective options besides chemotherapy and surgery.”

“It is very encouraging to see the strong interest and enthusiasm among the scientific community in our novel IMNN-001 program. Dosing the first patient is an important step forward and we expect to build on this momentum in the coming months as patient enrollment activities continue to accelerate in the OVATION 3 Study,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “We have great urgency around this program because patients do not have any other options besides the standard of care, which includes neoadjuvant and adjuvant chemotherapy and surgery. We have the resources in place needed to advance IMNN-001 efficiently and we are well positioned to fulfill our promise to help improve the standard of care for thousands of women worldwide with advanced ovarian cancer.”

The Phase 3 OVATION 3 trial is designed to assess the safety and efficacy of IMNN-001 (100 mg/m² administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard of care (SoC) N/ACT alone. Study participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3C or 4) who are eligible for neoadjuvant therapy, the intent-to-treat 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, 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.

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