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Gearing Up to Initiate Phase 3 Ovarian Cancer Trial
Imunon, Inc. (NASDAQ:IMNN) is continuing preparations to conduct a Phase 3 clinical trial of its lead development compound, IMNN-001, in patients with advanced ovarian cancer. IMNN-001 is a DNA immunotherapeutic drug that consists of an interleukin (IL)-12 expressing plasmid that allows for the durable, local, and targeted expression of IL-12 in the peritoneum. IL-12 is a potent pro-inflammatory cytokine that mediates a number of important cellular processes, including T cell and natural killer cell activation (Bashyam, 2007), the production of interferon-gamma (Zhao et al., 2012), and alteration of myeloid-derived suppressor cells in the tumor microenvironment (Kerkar et al., 2011). While shown to be effective in pre-clinical tumor models, IL-12 therapy initially showed underwhelming results in the clinic along with very high levels of toxicity when administered systemically. This is likely due to the fact that the direct targets of IL-12 are not circulating lymphocytes, but rather immune cells located within the tumor and lymph nodes. Thus, while systemic IL-12 therapy is not possible, localized delivery of IL-12 in and around the tumor has the potential to showcase its potent immune stimulating effects while minimizing toxic side effects.
Multiple strategies are currently being developed to deliver IL-12 to the tumor microenvironment and minimize systemic toxicity, including collagen-binding domain (CBD)-IL-12 (Mansurov et al., 2020), NHSAb-IL-12 (Franks et al., 2023), and mRNA (Liu et al., 2024). IMNN-001 leads to a durable increase in IL-12 at and near the tumor without accompanying systemic increases to help alleviate toxicity. These high local levels of IL-12 expression results in a more effective approach to counteracting the immunosuppressive environment. In addition, there has been no evidence of cytokine release syndrome due to this increased expression of IL-12. The use of a DNA plasmid results in sustained expression of IL-12 for several days, compared to continual infusions required with recombinant IL-12, and shorter expression times for mRNA therapies.
OVATION-2 Results
Initial results for the Phase 2 OVATION-2 Trial were released in July 2024 and for a full analysis of the results please see our previous report here. Briefly, the results showed that in the intent-to-treat (ITT) population, treatment with IMNN-001 resulted in an 11.1 month increase in overall survival (OS) with a hazard ratio (HR) of 0.74. Since the release of the data the company has continued to follow-up with patients, and in December 2024 announced that the increase in OS went up further from 11.1 months to 13 months and the HR decreased from 0.74 to 0.69. Importantly, these are the first study results for this patient population to show an increase in OS.