IMUNON, Inc. (NASDAQ: IMNN) has announced a positive outcome from its Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) regarding the production of IMNN-001 for treating women with newly diagnosed advanced ovarian cancer. This agreement supports the company's plan to initiate a Phase 3 pivotal trial in the first quarter of 2025.
The FDA's alignment on key CMC requirements is a significant step toward the potential commercialization of IMNN-001. The meeting included a review of IMUNON’s current good manufacturing practice (cGMP) clinical-scale and commercial manufacturing process at its Huntsville, Alabama facility.
Key Outcomes of the CMC Meeting
- Potency Assay Acceptance: The FDA agreed that IMUNON's potency assay, which measures interferon-gamma (IFN-γ), is acceptable for the Phase 3 clinical study and commercial use. This assay is critical for ensuring the quality and consistency of IMNN-001.
- Manufacturing Comparability: The FDA also agreed with IMUNON's strategy to establish comparability between the core components of IMNN-001 produced in-house and those previously produced through an external contract development and manufacturing organization (CDMO).
IMNN-001: A DNA-Mediated Immunotherapy
IMNN-001, developed using IMUNON's TheraPlas® platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system. This system enables cell transfection followed by persistent, local secretion of the IL-12 protein, a potent cytokine for inducing anticancer immunity.
Clinical Development and Future Plans
IMUNON is on track to initiate a 500-patient Phase 3 trial of IMNN-001 in the first quarter of 2025. This trial aims to evaluate the efficacy and safety of IMNN-001 in combination with standard-of-care chemotherapy for women with newly diagnosed advanced ovarian cancer.
Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON, stated, “We are very pleased with our recent FDA interactions as we continue to work collaboratively with the Agency to align on the most expeditious path to advance IMNN-001 into Phase 3 and toward potential commercialization for the thousands of women with newly diagnosed advanced ovarian cancer in need of additional treatment options.”
Addressing Unmet Needs in Ovarian Cancer
Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S., with approximately 20,000 new cases diagnosed annually. The five-year survival rates for patients diagnosed with advanced Stage III/IV disease are poor, highlighting the urgent need for therapies that reduce recurrence rates and improve overall survival. IMNN-001 represents a promising approach to immune modulation within the tumor microenvironment.
OVATION 2 Study Data
New translational data from the Phase 2 OVATION 2 study of IMNN-001 demonstrated a 20% increase in IL-12 levels in women treated with IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus standard-of-care (SoC) neoadjuvant and adjuvant chemotherapy (NACT) compared to IL-12 levels in women treated with IMNN-001 (79 mg/m2).
