IMUNON, Inc. (NASDAQ: IMNN) is set to host its first Ovarian Cancer R&D Day on September 18, 2024, in New York City, to present updates on its investigational therapy, IMNN-001, for the treatment of advanced ovarian cancer. The event will feature presentations from clinical study investigators, immunology and biostatistics experts, and IMUNON's executive management.
The Ovarian Cancer R&D Day follows IMUNON's recent announcement of positive topline data from its Phase 2 OVATION 2 study. The study revealed that treatment with IMNN-001 was associated with an 11.1-month increase in median overall survival (OS) in the intent-to-treat population, representing a 35% improvement in survival among patients with advanced disease.
OVATION 2 Study Results
The OVATION 2 study evaluated the dosing, safety, efficacy, and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. The open-label study enrolled 112 patients who were randomized 1:1 to compare NACT plus IMNN-001 versus standard-of-care NACT.
Key findings from the study include:
- An 11.1-month increase in median overall survival (OS) compared with standard-of-care alone in the intent-to-treat population (ITT).
- A hazard ratio in the ITT population of 0.74, indicating a 35% improvement in survival.
- Among the approximately 90% of trial participants who received at least 20% of specified treatments per-protocol in both study arms, patients in the IMNN-001 arm had a 15.7-month increase in median OS, representing a further extension of life with a hazard ratio of 0.64, a 56% improvement in survival.
- For the nearly 40% of trial participants treated with a poly ADP-ribose polymerase (PARP) inhibitor, the hazard ratio decreased further to 0.41, with median OS in the IMNN-001 treatment arm not yet reached at the time of database lock, compared with median OS of 37.1 months in the standard-of-care treatment arm.
IMNN-001: Mechanism of Action
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. IL-12 is a cytokine known for inducing potent anticancer immunity by stimulating T-lymphocyte and natural killer cell proliferation.
The Need for New Ovarian Cancer Therapies
Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S., with approximately 20,000 new cases diagnosed annually. Around 70% of cases are diagnosed in advanced Stage III/IV, characterized by tumor dissemination in the peritoneal cavity and a high risk of recurrence (75% in Stage III/IV) after surgery and chemotherapy. The five-year survival rates for patients with Stage III/IV disease at diagnosis remain poor (41% and 20%, respectively), highlighting the need for therapies that reduce recurrence and improve overall survival.
Future Development Plans
IMUNON executives will review the next steps in the development program for IMNN-001, including planning for a Phase 3 registration study. The company aims to change the treatment paradigm for women newly diagnosed with ovarian cancer, potentially impacting the standard of care.
