Imunon’s IL-12 gene therapy IMNN-001 converts the tumour microenvironment from “cold” to “hot” by both, halting immunosuppressive makers, and stimulating anti-tumour cells in advanced ovarian cancer, according to translational data presented at an ongoing conference.
These findings follow results from the Phase I/II study OVATION 2 (NCT03393884), which demonstrated a median increase in overall survival of 13 months in ovarian cancer patients treated with IMNN-001 plus standard-of-care, neoadjuvant and adjuvant chemotherapy (N/ACT), compared to N/ACT alone. The survival data was presented at the 2025 American Society of Oncology (ASCO) meeting.
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The latest translational data served to support downstream effects of IL-12 on the tumour microenvironment, utilising tissue samples from patients pre- and post-treatment with IMMN-001. The data was presented as a part of the American Association of Cancer Research (AACR) Special Conference in Cancer Research: Advances in Ovarian Cancer Research taking place in Denver, Colorado from 19–21 September.
Immunofluorescent analysis of patient samples revealed that IMNN-001 enhances recruitment of anti-tumour CD8+ and myeloid dendritic cells while blocking immunosuppressive markers such as IDO, PDL1 and T-reg cells, in the majority of patients. Imunon also reports induction of favourable ratios of CD8+/Tregs and CD8+/CD4+ cells, linked to enhanced survival in patients.
IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle to facilitate cell transfection, and is delivered intraperitoneally for persistent, local secretion of the IL-12 protein. As a key modulator of anticancer immunity, production of IL-12 is postulated to exploit the body’s natural defences by activating both innate and adaptive immune responses to create a “hot” anti-tumour environment.
Due to its immunomodulatory properties, IL-12 has long stood as a critical target in the development of novel cancer treatments. Pharma companies have previously investigated the potential of developing therapies targeting IL-12 in various indications. However, these have been hindered by hepatic toxicity and risk of immune system overstimulation caused by cytokine release syndrome.
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By GlobalDataSeveral efforts have been made to enhance specificity of IL-12-based therapeutics, such as fusion with antibodies for specific tumour antigens, or exploitation of chimeric antigen-receptor (CAR)-T technologies. Though more targeted approaches have seen reduced toxicity, this has often come at the cost of anti-tumour efficacy, resulting in several abandoned IL-12-targeted programs by companies like Obsidian Therapeutics and Ichor Medical Systems.
What’s next for Imunon’s IMNN-001?
Imunon has announced that the Phase III trial OVATION 3 is currently enrolling patients at four trial sites with up to 46 additional sites being considered for activation.
Before filling for approval, Imunon will need to build on existing data to demonstrate most efficacy of IMNN-001 against the current standard of care in women with advanced epithelial ovarian cancer.
Significant unmet need remains in epithelial ovarian cancer, with 80% of cases diagnosed in advance stage (III/IV) and a less than 40% survival.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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