The OVATION 3 Study Initiates First Trial Site for Ovarian Cancer

The first site has opened for the OVATION 3 study testing IMNN-001 in women newly diagnosed with advanced ovarian cancer.

The first trial site has been initiated for a phase 3 pivotal study entitled OVATION 3, which will investigate IMNN-001 treatment for patients with newly diagnosed advanced ovarian cancer, according to a news release from Imunon, Inc.

This site launch is important for patients with advanced ovarian cancer, as IMNN-001 is the first and only immunotherapy to show meaningful overall survival benefit in a phase 2 trial within this patient population.

The news release went on to add that this trial site is located at the Washington University School of Medicine, in St. Louis, Missouri. The Company is working on enrolling study participants at this location, as well as initiating additional trial sites.

“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,” Dr. Premal H. Thaker, study-level principal investigator of the OVATION 3 trial, said in the news release. “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.”

Thaker is the interim chief of Gynecologic Oncology, David & Lynn Mutch Distinguished professor of Obstetrics and Gynecology, and director of Gynecologic Oncology Clinical Research at Washington University School of Medicine.

The phase 3 trial will evaluate intraperitoneal (within the peritoneal cavity [the area that contains the abdominal organs]), weekly IMNN-001 given at 100 milligrams per square meter (mg/m2) plus neoadjuvant and adjuvant chemotherapy compared with standard of care treatment. Investigators aim to best understand the safety and efficacy of the combination.

Women are eligible for the study if they present with newly diagnosed advanced ovarian cancer (stage 3c or 4) and are eligible for neoadjuvant therapy. These participants will then be randomized to either the investigative or comparator arm of treatment, forming the intent-to-treat population. A subgroup of patients who test positive for homologous recombination deficiency, as well as BRCA1 or BRCA2 mutations, will receive PARP inhibitors as part of standard maintenance therapy.

Notably, the primary end point of the trial is overall survival; secondary end points include surgical response score, chemotherapy response score, clinical response and time to second-line treatment.

New data on IMNN-001 from OVATION 2 will be shared during an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, being held May 30 to June 3.

IMNN-001 is an immunotherapy agent which uses a delivery technology called TheraPlas. The agent is designed to enhance the IL-12 protein which boosts a patient’s ability to fight cancer by activating T-cells and natural killer cells. In early studies, IMNN-001 showed safety results when used alone or with chemotherapy in patients with advanced ovarian cancer. In a completed phase 2 trial, the therapy was investigated in comparison with chemotherapy alone in 112 patients with newly diagnosed advanced ovarian cancer, resulting in beneficial results which supported the agents continued research in larger trials.

“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,” Dr. Stacy Lindborg, president and CEO of IMUNON, stated in the news release. “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.”

For more information regarding the OVATION 2 trial, please visit www.clinicaltrials.gov using the identifier: NCT03393884.

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