IMUNON Launches First Site For Phase 3 OVATION 3 Trial Of IMNN-001 In Newly Diagnosed Advanced Ovarian Cancer

IMUNON, Inc., a clinical-stage biotechnology company advancing DNA-mediated immunotherapy, has announced the initiation of the first trial site for its Phase 3 pivotal study, OVATION 3, evaluating lead candidate IMNN-001 for the treatment of newly diagnosed advanced ovarian cancer in women. The first site activated for this trial is the Washington University School of Medicine, with additional sites currently being initiated as the company works with investigators to begin enrolling participants.

The OVATION 3 study will assess the safety and efficacy of IMNN-001, administered intraperitoneally at 100 mg/m² weekly, in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) using paclitaxel and carboplatin. This regimen will be compared against the standard of care N/ACT alone. Participants will be randomized in a 1:1 ratio and will include women with newly diagnosed stage 3C or 4 ovarian cancer who are eligible for neoadjuvant therapy. 

“This represents a significant step forward for the IMNN-001 development program as we work toward bringing patients this novel IL-12 immunotherapy, the first and only product to show meaningful overall survival benefit in women newly diagnosed with advanced ovarian cancer who have not seen changes in standard of care treatment in more than 25 years. It has been rewarding to be part of IMNN-001’s development for more than a decade and see the progress being made, with highly encouraging data from the Phase 2 study including in women treated with PARP inhibitors as maintenance therapy. I look forward to helping advance the OVATION 3 trial and seeing the results,” said Premal H. Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, and study-level principal investigator of the OVATION 3 trial.

Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON, mentioned, “Initiating the first site for our Phase 3 pivotal trial is an important milestone in our efforts to make IMNN-001 available to women who receive the devastating diagnosis of advanced ovarian cancer and are in urgent need of additional treatment options. We are grateful for the continued dedication and support of our team, the investigators and, most importantly, the participants in our clinical trials and their families to help get us to where we are today. Together, we look forward to this next stage of development for IMNN-001, with the latest results bringing new hope that this therapy may make a meaningful difference in people’s lives.”

The trial will evaluate the full intent-to-treat (ITT) population, with a subgroup analysis focusing on women with homologous recombination deficiency (HRD), including those with BRCA1 or BRCA2 mutations. Those in the HRD-positive subgroup will receive PARP inhibitors as part of their standard maintenance therapy. The primary endpoint of OVATION 3 is overall survival (OS), with secondary endpoints including surgical response score, chemotherapy response score, clinical response, and time to second-line treatment. 

Additionally, the study will assess several exploratory endpoints to provide further insight into IMNN-001’s therapeutic potential. IMUNON previously reported encouraging results from its Phase 2 OVATION 2 trial of IMNN-001 in December 2024 and plans to present new clinical data from this study during an oral session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 to June 3, 2025, in Chicago, Illinois.