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Business Update
Translational Data from OVATION 2 Trial Presented at AACR Special Conference
On September 22, 2025, Imunon, Inc. (NASDAQ:IMNN) announced that new translational data from the Phase 2 OVATION 2 trial of IMNN-001 was presented at the American Association for Cancer Research (AACR) Special Conference in Cancer Research: Advances in Ovarian Cancer Research. The poster can be found here.
The data consisted of an analysis of immune markers expression (CD8, CD11c, CD44, CD4, HLA-DR, CD45, CD45RO, Ki67, CD14, CD3, CD20, CD56, HLA-A, CD68, CD163, CD11b, CD16, Pan CK, FOXP3, PD-L1, PD-1, and IDO-1) in tumor samples from patients before and after treatment with IMNN-001. The following figure gives normalized changes in cell density for a subset of patients. The first row shows a favorable shift in the TME to immune stimulatory T cell ratios in the majority of patients, as exhibited by higher CD8+/Treg, CD8+/IDO+, and CD8+/CD4+ ratios. The second row shows a trend in favor of decreased immunosuppression through a decrease in the number of IDO+, PDL1+, Treg, and CD4+ cells in the majority of patients. The third row shows the shift to increased immune stimulatory cells as shown by an increase in CD8+, CD8+ effector, and myeloid dendritic cells in a majority of patients.
Conclusion
These biomarker results confirm that IMNN-001 is actively creating a “hot” anti-tumor microenvironment through the recruitment of anti-tumor CD8+ cells and a decrease in expression of immunosuppressive markers, and are consistent with the positive overall survival data seen in the OVATION 2 study. The company has initiated the Phase 3 OVATION 3 trial of IMNN-001 in patient with newly diagnosed advanced ovarian cancer and currently has four sites actively recruiting patients. We anticipate additional trial sites being opened to accelerate enrollment and we look forward to additional updates on the trial as warranted. With no changes to our model our valuation remains at $45 per share.
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