IMUNON Shares Positive Phase 2 OVATION 2 Trial Results of IMNN-001 in Advanced Ovarian Cancer at SITC 39th Meeting

IMUNON, Inc., a biotechnology firm specializing in advanced DNA-mediated immunotherapy, recently announced positive clinical data from their Phase 2 OVATION 2 Study of IMNN-001, an investigational interleukin-12 (IL-12) immunotherapy for treating advanced ovarian cancer. The results were shared during a late-breaking poster session at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting held in Houston, Texas, and online.

IMNN-001 is a unique IL-12 DNA plasmid vector encased in a nanoparticle delivery system, facilitating cell transfection and continuous local IL-12 protein production. IL-12 is known for inducing strong anticancer immunity by promoting T-lymphocyte and natural killer cell proliferation, and suppressing tumor-induced immune evasion.

In the OVATION 2 Study, 112 patients with newly diagnosed advanced ovarian cancer were enrolled and observed over a median follow-up period of 24 months. Participants were randomized into two groups: one receiving IMNN-001 plus neoadjuvant and adjuvant chemotherapy (NACT) with paclitaxel and carboplatin, and the other receiving standard-of-care NACT alone. The study aimed to assess the safety and efficacy of IMNN-001.

Key findings from the study include:
- The combination of IMNN-001 immunotherapy with standard chemotherapy led to a 35% improvement in overall survival (OS), extending the median OS to 40.5 months compared to 29.4 months for standard chemotherapy alone.
- Surgical outcomes improved with a 64.6% response rate in the IMNN-001 group compared to 52.1% in the control group.
- Progression-free survival (PFS) also saw a notable improvement, with a median PFS of 14.9 months in the IMNN-001 group versus 11.9 months in the control group.
- Subgroup analysis revealed that patients receiving a PARP inhibitor as maintenance therapy had a median PFS of 33.8 months with IMNN-001, compared to 22.1 months in the control group, with the median OS not yet reached for the IMNN-001 group.

The treatment was well tolerated, with the most common adverse events being gastrointestinal issues such as abdominal pain, nausea, and vomiting. Importantly, no cases of cytokine release syndrome or other severe immune-related adverse events were reported.

Dr. Stacy Lindborg, President and CEO of IMUNON, expressed optimism about the results, noting their potential to translate into a significant advancement in ovarian cancer treatment. Dr. Jennifer Scalici, a study investigator, emphasized that IMNN-001 is the first immunotherapy to show clinically significant benefits in both PFS and OS for ovarian cancer, especially in a first-line treatment setting.

IMUNON plans to start a Phase 3 pivotal trial of IMNN-001 in the first quarter of 2025, following an end-of-Phase 2 meeting with the FDA to discuss the trial's design.

The OVATION 2 study explored the dosing, safety, and efficacy of IMNN-001 in conjunction with NACT. Designed to shrink tumors before optimal surgical removal, the treatment involved three cycles of chemotherapy, followed by surgery and three more cycles of adjuvant chemotherapy to address any remaining tumor cells. Patients were randomized 1:1 into either the treatment arm receiving IMNN-001 plus NACT or the control arm receiving standard-of-care NACT alone. The study, although not powered for statistical significance, provided promising additional endpoints including objective response rate, chemotherapy response score, and surgical response.

IMUNON’s proprietary TheraPlas® platform underpins the development of IMNN-001, enabling the localized secretion of IL-12, which is crucial for potent anticancer responses. Past studies have shown positive safety and efficacy results for IMNN-001 as a monotherapy or in combination with chemotherapy in patients with advanced ovarian cancer.

Epithelial ovarian cancer remains a significant health challenge with high recurrence rates and poor survival outcomes, particularly in advanced stages. IMUNON aims to address this unmet need with innovative therapies like IMNN-001, improving both recurrence rates and overall survival for ovarian cancer patients.