NASDAQ:IMNN
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Business Update
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.
A subgroup analysis was performed for those patients that received PARP inhibitor (PARPi) therapy. Those results showed that the median OS was not reached for the PARPi group receiving IMNN-001 and standard of care compared to 37.1 months for the PARPi group only receiving standard of care (HR=0.41).
In addition to the increase in OS, the follow-up results showed that more than 1/3rd of patients survived more than 36 months, with 62% of those patients from the IMNN-001 cohort and 38% from the standard-of-care cohort. The updated results also continued to show a favorable safety profile with no reports of serious immune-related adverse events.
Planning for Phase 3 Trial
In November 2024, Imunon announced it had reached alignment with the U.S. Food and Drug Administration (FDA) following an ‘End-of-Phase 2’ meeting on the company’s proposed plan for a Phase 3 trial of IMNN-001 in patients with advanced ovarian cancer, including the trial strategy, overall trial design, target patient population, treatment schedule, and primary endpoint. In addition, in December 2024 the company announced a positive Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. FDA in which alignment was reached regarding the production of IMNN-001, including the acceptability of the company’s potency assay that measures interferon gamma is acceptable for both the Phase 3 clinical study and in a commercial setting for release of the drug. We continue to expect the Phase 3 trial will initiate before the end of the first quarter of 2025.
Conclusion
Having reached alignment with the FDA regarding both the clinical and CMC plans for the planned Phase 3 ovarian cancer trial, Imunon can now turn its attention to securing the funding necessary to conduct the trial. At this point, the company is entertaining multiple strategies for financing the Phase 3 trial, with some cost savings to be captured through the in-house manufacturing of drug product at the company’s own manufacturing facility. We expect an update from the company as soon as is warranted. With no changes to our model our valuation remains at $8.00 per share.
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