IMUNON Completes Phase 3 Study Plan with FDA for IMNN-001 in Advanced Ovarian Cancer

IMUNON, Inc., a clinical-stage biotechnology company, has reached a significant milestone in its development of a novel immunotherapy for the treatment of advanced ovarian cancer. The U.S. Food and Drug Administration (FDA) has given its approval to the protocol for IMUNON's Phase 3 pivotal trial, known as OVATION 3, for its leading candidate, IMNN-001. This trial is set to explore the potential of IMNN-001 in providing a new treatment option for women newly diagnosed with advanced ovarian cancer.

The upcoming Phase 3 trial follows promising results from a previous Phase 2 study, which demonstrated that IMNN-001 was the first immunotherapy to produce a meaningful overall survival benefit in patients with advanced ovarian cancer. The trial aims to assess the safety and efficacy of IMNN-001 when combined with neoadjuvant and adjuvant chemotherapy (NACT) using paclitaxel and carboplatin, compared to the current standard of care which includes NACT alone.

In this pivotal trial, participants will be randomized in a 1:1 ratio. The study will focus on women who have been newly diagnosed with advanced ovarian cancer, specifically those eligible for neoadjuvant therapy. Additionally, the trial will include a subgroup of women who are positive for homologous recombination deficiency (HRD), including those with BRCA1 or BRCA2 mutations. For participants with HRD positivity, the trial will incorporate poly ADP-ribose polymerase (PARP) inhibitors as part of their standard maintenance therapy. The primary endpoint will be overall survival, with secondary endpoints including surgical response score, chemotherapy response score, clinical response, and time to the need for second-line treatment.

The previous Phase 2 OVATION 2 study showed that IMNN-001 combined with NACT improved median overall survival to 46 months, surpassing standard NACT by 13 months. Furthermore, IMNN-001 was noted for its favorable safety profile, with no instances of cytokine release syndrome or other serious adverse events.

IMUNON is currently working on initiating trial sites and is actively collaborating with investigators to begin participant enrollment swiftly. They are also hosting a conference call to discuss the upcoming Phase 3 OVATION 3 trial, where key figures like Dr. Premal H. Thaker and Dr. L.J. Wei will join the discussion.

IMNN-001 is part of IMUNON's TheraPlas® platform, which utilizes a DNA plasmid vector system encased in nanoparticles to facilitate cell transfection and local secretion of the IL-12 protein. This protein is instrumental in triggering an immune response against cancer cells, predominantly through the activation of T-lymphocytes and natural killer cells.

Epithelial ovarian cancer remains a significant health challenge, being the sixth leading cause of cancer-related deaths among women in the United States. With approximately 20,000 new cases annually, many diagnosed at an advanced stage, there is a critical need for new therapies that can improve survival rates and reduce recurrence.

IMUNON's innovative approach in developing DNA-mediated immunotherapy offers a promising new avenue for treating this aggressive cancer. The company remains committed to advancing its technology to deliver safe, effective, and durable cancer treatments and continues to explore further business development opportunities to strengthen its position in the biotechnology industry.