Zacks Small Cap Research – IMNN: Comes to Alignment with FDA Regarding Phase 3 Protocol for IMNN-001… – Technologist

By David Bautz, PhD

NASDAQ:IMNN

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Business Update

Reaches Alignment with FDA Regarding Phase 3 Trial Plan

On November 25, 2024, Imunon, Inc. (NASDAQ:IMNN) 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. We expect the finalized trial protocol to be submitted in December 2024 and for the Phase 3, 500-patient trial to initiate in the first quarter of 2025.

IMNN-001 is a DNA immunotherapeutic drug that consists of an interleukin (IL)-12 plasmid that allows for the targeted expression of IL-12 to avoid toxicities and the poor pharmacokinetics of systemically administered IL-12. The company previously presented results from the Phase 2 OVATION 2 trial, which included an approximately one-year increase in overall survival (OS), which was further increased to 15.7 months for patients that received at least 20% of protocol-specified treatments. For patients also on a PARP inhibitor, the median OS was not yet reached compared to 37.1 months for those receiving only standard of care therapy. Importantly, IMNN-001 was well tolerated with the most common adverse events being abdominal pain (which was well controlled with standard or care pain therapies), nausea, and vomiting. These results are an exciting advancement in the treatment of ovarian cancer and if replicated in the Phase 3 trial could lead to a change in the standard of care for women with advanced ovarian cancer. 

Conclusion

Imunon is well positioned to initiate the Phase 3 trial of IMNN-001 in advanced ovarian cancer now that alignment has been reached with the FDA regarding the Phase 3 plan. We look forward to the initiation of the trial in the first quarter of 2025 and also anticipate an update from the company on its plan for financing the study. With no changes to our model our valuation remains at $8.00 per share.

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