Imunon, Inc.’s (NASDAQ: IMNN) stock price has increased dramatically after the release of topline data from a critical clinical study. According to the most recent report, IMNN’s shares have increased 149.58% to $2.96.
Good Results in the Second Phase of the OVATION Study
Positive topline data from the Phase 2 OVATION 2 research, which assessed IMNN-001’s effectiveness in patients with advanced ovarian cancer, have been released by Imunon. In this randomized trial, IMNN-001 was given in addition to neoadjuvant and adjuvant chemotherapy (NACT) whereas the control group received NACT as usual.
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Interleukin-12 (IL-12) immunotherapy IMNN-001 is based on TheraPlas technology from the business. The study found that patients in the intent-to-treat group who received IMNN-001 in addition to standard-of-care medication had a median gain in overall survival (OS) of 11.1 months relative to those who received standard-of-care alone.
IMNN saw a significant 56% increase in survival in patients in both trial groups who adhered to the treatment plan and received at least 20% of the suggested medicines. This resulted in a median OS increase of 15.7 months and a hazard ratio of 0.64.
Imunon: Implications and Future Directions
The hazard ratio further improved to 0.41 among the roughly 40% of patients treated with a poly ADP-ribose polymerase (PARP) inhibitor; in the standard-of-care arm, the median OS was 37.1 months, while in the IMNN-001 treatment arm, it had not yet been attained.
These promising Phase 2 results, while not statistically powered for significance, indicate that IMNN-001 may substantially enhance outcomes for women with advanced ovarian cancer.
The consistency of the results, particularly in progression-free survival and the additional 15.7 months of life gained by patients receiving three or more doses of IMNN-001, supports the potential long-term benefits of the IL-12 gene therapy. The safety profile of IMNN-001 was also deemed tolerable.
The U.S. Food and Drug Administration (FDA) and Imunon are getting ready for an End-of-Phase 2 conference to talk about the protocol for a Phase 3 research, which is anticipated to start in the first quarter of 2025.
In addition, the business intends to submit these data for publication in a peer-reviewed journal and present the complete results of the OVATION 2 Study at a forthcoming medical conference.
