IMUNON, Inc. (NASDAQ: IMNN) reported positive topline results from its OVATION 2 Study, showcasing the potential of IMNN-001, a DNA-based immunotherapy, in treating advanced ovarian cancer. The study revealed a significant 11.1-month increase in median overall survival (OS) compared to the standard of care in the intent-to-treat (ITT) population.
The results, presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, have garnered considerable attention from global medical and scientific leaders. IMUNON is actively engaging with the U.S. Food and Drug Administration (FDA) to finalize the design of its planned registrational study and is preparing for an in-person End-of-Phase 2 meeting with the agency later this month. The company anticipates commencing a 500-patient pivotal Phase 3 study in the first quarter of 2025.
OVATION 2 Study: Key Findings
The OVATION 2 study evaluated IMNN-001 in combination with standard of care as a first-line treatment for advanced ovarian cancer. Key findings include:
- An 11.1-month increase in median OS in the ITT population, with a hazard ratio of 0.74, representing a 35% improvement in survival.
- In patients who received at least 20% of specified treatments per-protocol, the IMNN-001 arm showed a 15.7-month increase in median OS, with a hazard ratio of 0.64, indicating a 56% improvement in survival.
- For approximately 40% of trial participants treated with a poly ADP-ribose polymerase (PARP) inhibitor, the hazard ratio decreased to 0.41, with the median OS in the IMNN-001 treatment arm not yet reached at the time of database lock, compared to 37.1 months in the standard-of-care arm.
- A three-month improvement in progression-free survival (PFS) compared with standard of care alone, with a hazard ratio in the ITT population of 0.79, indicating a 27% improvement in delaying progression for the IMNN-001 treatment arm.
Expert Commentary
"The third quarter was a period of important milestones and outstanding progress for IMUNON, driven largely by presentation of highly compelling topline results from our OVATION 2 Study with IMNN-001 in advanced ovarian cancer," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "In this study, treatment with IMNN-001 was associated with an overall survival improvement of 11.1 months compared to treatment with standard of care, and results were even stronger in the subset of patients who were also treated with PARP inhibitors."
Financial Position
As of September 30, 2024, IMUNON reported $10.3 million in cash, investments, and accrued interest receivable. The company believes it has sufficient capital to fund operations into the third quarter of 2025.
About IMNN-001
IMNN-001 is a DNA-based immunotherapy designed for the localized treatment of advanced ovarian cancer. It works by instructing the body to produce cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site.
