IMUNON Releases Phase 1/2 OVATION 2 Study Data on IMNN-001 for Advanced Ovarian Cancer

IMUNON, Inc., a clinical-stage biotechnology company based in Lawrenceville, N.J., has released promising translational data from its Phase 2 OVATION 2 Study on IMNN-001, an interleukin-12 (IL-12) immunotherapy designed for advanced ovarian cancer treatment. This investigational therapy, delivered via IMUNON's proprietary TheraPlas® technology, has shown a significant increase in IL-12 levels, a critical immunomodulatory cytokine, in patients receiving a higher dose of 100 mg/m² compared to those receiving 79 mg/m².

The data confirms previous Phase 1 findings and underscores the safety and potential efficacy of IMNN-001, particularly in improving progression-free survival and overall patient outcomes when used alongside standard chemotherapy. Stacy Lindborg, Ph.D., IMUNON's president and CEO, highlighted the positive benefit-risk profile of IMNN-001, expressing optimism about its role in transforming treatment for advanced ovarian cancer patients. The company is poised to commence a pivotal Phase 3 trial later this quarter.

The analysis focused on IL-12 level changes within the peritoneal cavity, the primary tumor microenvironment, with minimal changes detected systemically. This local cytokine elevation was accompanied by increased levels of interferon-gamma (IFN-γ) and tumor necrosis factor-alpha (TNF-α), both vital in anti-cancer immune responses. Importantly, no serious immune-related adverse effects were reported, including cytokine release syndrome.

Dr. Premal H. Thaker, interim chief of gynecologic oncology at Washington University School of Medicine and OVATION 2 Study Chair, emphasized that these results demonstrate IMNN-001's ability to bolster cancer-fighting cytokines with limited systemic toxicity. The continued positive survival data from this study, which included a median overall survival improvement of 13 months for those receiving the higher IMNN-001 dose with standard chemotherapy, further supports its potential impact. Notably, over one-third of participants survived beyond 36 months, with a higher survival rate observed in the IMNN-001 treatment group.

Moving forward, IMUNON plans to advance IMNN-001 into a Phase 3 trial, leveraging insights gained from the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in December 2024. This upcoming study will use the 100 mg/m² dose, aiming to solidify the therapy's role in ovarian cancer treatment.

The Phase 2 OVATION 2 Study investigated the safety, efficacy, and biological activity of IMNN-001 administered intraperitoneally in conjunction with neoadjuvant and adjuvant chemotherapy (NACT) for patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study, featuring 112 participants, compared these patients receiving IMNN-001 plus NACT against those receiving standard NACT. The results provided preliminary evidence of the therapy's potential, although the study was not statistically powered for definitive conclusions.

IMNN-001 is developed using IMUNON's TheraPlas® platform, which facilitates DNA-based cytokine delivery for solid tumors. The novel approach enables local IL-12 protein secretion, promoting potent anticancer immunity through T-lymphocyte and natural killer cell activation. Previous studies, including a Phase 1b trial, have shown encouraging safety and efficacy results for IMNN-001, either as monotherapy or combined with chemotherapy, in treating peritoneally metastasized ovarian cancer.

Ovarian cancer, particularly the epithelial type, remains a significant health challenge, ranking as the sixth deadliest cancer among U.S. women. With high recurrence rates and low five-year survival rates for advanced-stage diagnoses, there is an urgent need for therapies that not only reduce recurrence but also improve overall survival. IMNN-001 targets this need, especially within the peritoneal cavity, the primary tumor site in advanced cases.

IMUNON is committed to advancing innovative treatments that harness the body's natural mechanisms, driving promising responses across various challenging conditions, including cancer. The company continues to explore its non-viral DNA technologies, with IMNN-001 as a leading candidate, alongside other clinical programs aimed at improving patient outcomes in hard-to-treat diseases.