IMUNON’s Novel Immunotherapy IMNN-001 Enhances Survival in Ovarian Cancer

IMUNON’s Phase 2 OVATION 2 study shows promising results for its immunotherapy, IMNN-001, in advanced ovarian cancer. Combined with standard chemotherapy, IMNN-001 improved overall survival by 35% and progression-free survival by 25% compared to standard treatment alone. The therapy was well-tolerated, with manageable side effects. Following these results, IMUNON plans a Phase 3 trial in early 2025, potentially advancing IMNN-001 as a new first-line option for ovarian cancer treatment.

At the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, IMUNON shared promising results from its OVATION 2 study of IMNN-001, an investigational interleukin-12 (IL-12) immunotherapy for the treatment of advanced ovarian cancer, based on the company’s proprietary TheraPlas® technology.

The survival benefits were consistent across various endpoints and patient subgroups—a factor IMUNON’s CEO, Dr. Stacy Lindborg, highlighted as particularly promising for replicating these results in a larger Phase 3 trial. “This consistency brings great hope and excitement that these results can be replicated in Phase 3, and that IMNN-001 may offer a significant advancement in the treatment landscape for ovarian cancer,” said Dr. Lindborg.

Improved Survival Outcomes

The OVATION 2 study enrolled 112 patients with newly diagnosed advanced ovarian cancer, each receiving either a combination of IMNN-001 with neoadjuvant and adjuvant chemotherapy (NACT) or NACT alone. 

After 24 months of follow-up, results indicated that patients treated with IMNN-001 lived approximately 11 months longer, with a median overall survival (OS) of 40.5 months compared to 29.4 months for those on standard treatment alone.

Progression-free survival (PFS) was also significantly enhanced. The median PFS in the IMNN-001 group reached 14.9 months, compared to 11.9 months for the control group, marking a 25% improvement.

Dr. Jennifer Scalici, Professor of Gynecological Oncology and lead investigator on the study, expressed optimism about IMNN-001's potential, especially when used in combination with PARP inhibitors, which are effective in treating advanced ovarian cancer yet have limitations in extending overall survival. "IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, let alone in a first-line treatment setting," said Dr. Scalici, “the study represents the potential of IMNN-001 to offer a much-needed treatment option.”

Enhanced Surgical Outcomes

Patients receiving IMNN-001 had a 64.6% surgical response rate, compared to 52.1% in the control group, suggesting that the new treatment may aid in reducing tumor burden before surgery. Additionally, IMNN-001 boosted the chemotherapy response score, an indicator of tumor reduction during chemotherapy, achieving a score of 26.1% compared to 13.0% in the standard-treatment group.

Tolerability and Safety Profile

The study found IMNN-001 to be generally well-tolerated, with most adverse events involving manageable gastrointestinal symptoms like abdominal pain, nausea, and vomiting. Importantly, there were no cases of cytokine release syndrome, nor any other serious immune-related adverse events.

Following these promising results, IMUNON plans to discuss a Phase 3 trial design with the U.S. FDA in an end-of-Phase 2 meeting. Expected to commence in early 2025, the upcoming Phase 3 trial will aim to confirm IMNN-001's efficacy on a larger scale. If the Phase 3 trial succeeds, IMNN-001 could become the first immunotherapy to achieve substantial efficacy in advanced ovarian cancer, offering new hope for women facing this challenging disease.