IMUNON has announced final clinical data from the completed phase-II OVATION 2 clinical trial evaluating IMNN-001 in combination with standard of care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT). The large randomised 112-patient study evaluated IMNN-001 in women with newly diagnosed advanced ovarian cancer. IMNN-001, the company’s lead drug candidate, utilises 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 (IL-12), altering the tumour microenvironment.

Based on prior data assessments, IMUNON previously reported a median 11.1-month increase in OS (40.5 vs. 29.4 months) 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 (45.1 vs. 30.4 months) in women in the IMNN-001 treatment arm compared to SoC alone, demonstrating continuous improvement in OS (3.6 delta). In addition, the new IMNN-001 data showed that women treated with IMNN-001 and SoC chemotherapy plus Poly ADP-Ribose Polymerase (PARP) inhibitors as part of maintenance therapy achieved a median increase in OS of 24.2 months (65.6 vs. 41.4 months) compared to SoC chemotherapy alone.

“It is very encouraging to see results from the OVATION 2 trial indicating that treatment with IMNN-001 was associated with an overall survival benefit of more than a year in patients treated with IMNN-001 plus chemotherapy and more than two years in women also receiving PARP inhibitors as part of maintenance therapy. These new findings are especially exciting given that there have been no meaningful advances in standard of care in ovarian cancer in the last 30 years,” said Premal H Thaker, MD, Chief of Gynaecologic Oncology, David and Lynn Mutch Distinguished Professor of Obstetrics and Gynaecology, Director of Gynaecologic Oncology Clinical Research, Washington University School of Medicine, OVATION 2 Study Chair and Study Chair of phase-III OVATION 3 trial.

“Importantly, with these new efficacy results, IMNN-001 continues to maintain a highly favourable safety and tolerability profile, further reinforcing the potential of this IL-12 immunotherapy to represent a landmark advance in treatment for women who are in desperate need of new and improved treatment options.”

The phase-III OVATION 3 trial is a clinical study with the primary endpoint of OS. The trial design includes two planned interim analyses of the primary endpoint, designed to allow for an accelerated timeline for potential submission of a Biologics Licence Application (BLA) for full approval of IMNN-001 to the US Food and Drug Administration (FDA) if the primary endpoint reaches statistical significance. OVATION 3 is currently enrolling patients at seven clinical sites with up to 43 additional sites being considered for activation. IMUNON anticipates enrolling approximately 80 patients (~20 percent) of the total target of 500 participants within the next year.

“With each new assessment of the findings from the OVATION 2 study, IMNN-001 has continued to show that it can improve overall survival in women with newly diagnosed advanced ovarian cancer while maintaining an advantageous safety profile. The strong response from our current trial investigators and the broader medical community supports our belief in the significant potential of IMNN-001 to make a meaningful difference in women’s lives. We remain focused on executing our phase-III trial and advancing this promising therapy to the final stage of regulatory review as quickly as possible,” said Stacy Lindborg, PhD., President and Chief Executive Officer (CEO), IMUNON.