Investing.com -- Imunon Inc (NASDAQ: IMNN ) stock surged 172% in premarket trading after the company announced significant survival data from its Phase 2 trial of IMNN-001, a treatment for newly diagnosed advanced ovarian cancer. The results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the peer-reviewed journal Gynecologic Oncology.
The trial, named OVATION 2, showed that patients treated with IMNN-001 in addition to standard neoadjuvant and adjuvant chemotherapy (N/ACT) experienced a median increase in overall survival (OS) of 13 months compared to those who received standard of care alone, boasting a hazard ratio of 0.69. The data also indicated a median 3-month increase in progression-free survival (PFS) for the same group, with a hazard ratio of 0.79.
Furthermore, patients treated with poly ADP-ribose polymerase (PARP) inhibitors as part of their maintenance therapy saw even more pronounced benefits. In this subgroup, the median OS has not been reached after more than five years, compared to 37 months in the control arm, suggesting a potential extension of life beyond one year for women with newly diagnosed advanced ovarian cancer.
The promising results have led to the initiation of the Phase 3 OVATION 3 Study, which will further investigate the efficacy of IMNN-001. The study will focus on overall survival as the primary endpoint and will include a subgroup of women positive for homologous recombination deficiency (HRD+), including those with BRCA1 or BRCA2 mutations.
IMNN-001 has been well received in terms of safety, with the most common adverse events being abdominal pain, nausea, and vomiting, and no reports of serious immune-related adverse events.
Stacy Lindborg, Ph.D., president and CEO of Imunon, expressed optimism about the potential of IMNN-001 to improve outcomes for women with advanced stages of ovarian cancer. Premal H. Thaker, M.D., Study Chair of the Phase 3 OVATION 3 trial, echoed this sentiment, highlighting the historic advance in standard of care that IMNN-001 could represent.
The Phase 3 OVATION 3 Study will continue to advance with the goal of bringing this novel therapy to women in need of new treatment options. The study will assess not only overall survival but also surgical response score, chemotherapy response score, clinical response, and time to second-line treatment among other exploratory endpoints.
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