IMUNON, Inc. (NASDAQ: IMNN) announced positive results from its Phase 2 OVATION 2 study of IMNN-001, an investigational therapy for advanced ovarian cancer. The study demonstrated a statistically significant 11.1-month increase in median overall survival compared to standard of care, representing a 35% improvement in survival. These findings will be presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting. The company is scheduled to meet with the FDA to discuss a Phase 3 pivotal trial, planned for Q1 2025.
Promising Phase 2 Results
The OVATION 2 study evaluated IMNN-001 in patients with newly diagnosed advanced epithelial ovarian cancer. The results showed a clinically meaningful increase in median overall survival, offering new hope for patients with this challenging disease. The 35% improvement in survival underscores the potential of IMNN-001 as a novel treatment option.
Mechanism of Action
IMNN-001 utilizes IMUNON’s TheraPlas® platform technology, a DNA-mediated immunotherapy. It is designed to produce and secrete interleukin-12 (IL-12) protein, a potent cytokine that stimulates anti-cancer immunity. IL-12 promotes the proliferation of T-lymphocytes and natural killer cells, enhancing the body's ability to fight tumors.
Path to Phase 3
IMUNON's upcoming meeting with the FDA will focus on the design of a Phase 3 pivotal study. The company anticipates initiating the Phase 3 trial in the first quarter of 2025. This trial will further evaluate the efficacy and safety of IMNN-001 in a larger patient population, potentially paving the way for regulatory approval.
Management Commentary
Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON, expressed enthusiasm about the results. "The growing body of evidence supporting IMNN-001 in the treatment of women with advanced ovarian cancer thus far is very encouraging," she stated. "We are hopeful that the FDA’s interest in meeting in person...suggests a deep interest in IMNN-001 and its promise as demonstrated in the Phase 2 study."
