Imunon Surges on Survival Data for IL-12 in Ovarian Cancer

Imunon experienced a significant surge in its stock value, rising over 150% on Tuesday, following the announcement of favorable results from its Phase II trial of the IL-12 immunotherapy for ovarian cancer. The OVATION 2 study involved 112 patients with advanced ovarian cancer, who were randomly assigned to receive IMNN-001 alongside neoadjuvant and adjuvant chemotherapy (NACT) or NACT alone, which is the current standard treatment. Although the study was not designed to achieve statistical significance, IMNN-001 demonstrated a median overall survival (OS) benefit of 11.1 months.

In the experimental arm of the trial, where patients received IMNN-001, the hazard ratio was 0.74, indicating a 35% improvement in survival compared to those who received only NACT. Notably, patients who were administered at least three out of the 17 planned doses of IMNN-001 saw a dramatic increase in their median OS, with a 15.7-month improvement. This subgroup exhibited a hazard ratio of 0.64, translating to a 56% enhancement in survival rates.

Regarding progression-free survival (PFS), the primary endpoint of the study, IMNN-001 led to a three-month improvement compared to NACT alone. The hazard ratio for PFS was 0.79, suggesting that IMNN-001 delayed disease progression by 27% relative to chemotherapy alone.

Premal Thaker, chair of the OVATION 2 study and director of gynecologic oncology clinical research at Washington University School of Medicine, highlighted that the 11-month extension in survival is particularly notable, given that a six-month increase is typically deemed clinically meaningful. Thaker expressed optimism that if the OS benefit observed with IMNN-001 is confirmed in a Phase III trial, it could potentially establish a new standard of care for women suffering from ovarian cancer.

Imunon has announced its intention to consult with the FDA promptly to finalize the protocol for a Phase III study of IMNN-001, which is anticipated to commence in the first quarter of 2025. Additionally, the company plans to present the comprehensive data from the OVATION 2 trial at an upcoming medical conference and will submit the findings to a peer-reviewed medical journal for publication.