IMNN News & Events

Imunon announced that the independent Data Monitoring Committee, or IDMC, has recommended continuation of the pivotal Phase 3 OVATION 3 clinical trial evaluating IMNN-001 in combination with standard of care neoadjuvant and adjuvant chemotherapy in women with newly diagnosed advanced ovarian cancer. "We are very pleased that the iDMC has recommended continuation of the landmark OVATION 3 clinical trial without modification, representing another important validation of the remarkable efficacy and safety data previously reported and further indicating the potential for IMNN-001 to represent a historic advance in the treatment of ovarian cancer," said Stacy Lindborg, president and chief executive officer of Imunon. "We remain ahead of our anticipated schedule in patient enrollment and this recommendation by the iDMC brings new levels of momentum to our efforts to advance this trial as rapidly as possible."

"Enrollment in our pivotal Phase 3 OVATION 3 trial continues ahead of plan, reflecting patient interest and strong conviction among principal investigators and the broader medical community in IMNN-001's therapeutic potential," said Stacy Lindborg, President and Chief Executive Officer of IMUNON. "Coupled with the unprecedented overall survival benefit observed in our Phase 2 study and an aligned path to BLA filing, IMNN-001 is well positioned to potentially transform the standard of care in advanced ovarian cancer."

Imunon announced final clinical data from the completed Phase 2 OVATION 2 clinical trial evaluating IMNN-001 in combination with standard of care neoadjuvant and adjuvant chemotherapy. The large randomized 112-patient study evaluated IMNN-001 in women with newly diagnosed advanced ovarian cancer. IMNN-001, the company's lead drug candidate, utilizes its proprietary non-viral DNA delivery platform, TheraPlas, the only nucleic acid nanoparticle technology showing promise in treating cancer. This novel immunotherapy is designed to recruit the entirety of the immune system by enabling locoregional secretion of the powerful cancer-fighting cytokine interleukin 12, altering the tumor microenvironment. Based on prior data assessments, IMUNON previously reported a median 11.1-month increase in OS in the IMNN-001 treatment arm compared to SoC chemotherapy alone. Following the most recent data assessment, the company is now reporting a median 14.7-month increase in OS in women in the IMNN-001 treatment arm compared to SoC alone, demonstrating continuous improvement in OS. In addition, the new IMNN-001 data showed that women treated with IMNN-001 and SoC chemotherapy plus poly ADP-ribose polymerase inhibitors as part of maintenance therapy achieved a median increase in OS of 24.2 months compared to SoC chemotherapy alone.