Imunon (NASDAQ: IMNN) stock skyrocketed during intraday trading Tuesday following the release of topline results from the Phase 2 OVATION 2 Study. The study evaluated IMNN-001 in patients with advanced ovarian cancer.
OVATION 2 is a randomized study of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) inclusive of interval debulking or cytoreductive surgery compared with a control arm of standard-of-care NACT alone.
IMNN-001 is the Company’s interleukin-12 (IL-12) immunotherapy based on its TheraPlas™ technology.
Key Results
Highlights from patients treated with IMNN-001 plus standard-of-care in a first-line treatment setting include:
- An 11.1-month increase in median OS compared with standard-of-care alone in the intent-to-treat population (ITT).
- A hazard ratio in the ITT population of 0.74, indicates 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.
The PFS results, the trial’s primary endpoint, support the OS results with:
- A three-month improvement in PFS compared with standard-of-care alone.
- A hazard ratio in the intent-to-treat population of 0.79, indicating a 27% improvement in delaying progression for the IMNN-001 treatment arm.
IMUNON plans to hold an End-of-Phase 2 meeting with the U.S. Food and Drug Administration as soon as possible to discuss the protocol for a Phase 3 study, which is anticipated to begin in the first quarter of 2025. IMUNON also plans to present full OVATION 2 Study results at an upcoming medical conference and to submit the results for publication in a peer-reviewed medical journal.
Imunon (NASDAQ: IMNN) Stock Price Action
IMNN stock soared 178.99% on Tuesday, closing at $3.32, marking a 165.60% increase for the week. The trading volume was 140,534,974 shares, significantly higher than the average daily volume of 163.38K.
