IMUNON Inc. (IMNN) reported new Phase 2 results showing that women treated with its experimental immunotherapy IMNN-001 lived significantly longer than those who received standard chemotherapy alone- reinforcing the drug's potential in newly diagnosed advanced ovarian cancer.
Newly diagnosed advanced ovarian cancer remains one of the most challenging cancers to treat, with limited progress in standard therapies over the past three decades. IMUNON is developing IMNN-001, a DNA-based IL-12 immunotherapy delivered directly into the tumor region using IMUNON's TheraPlas platform. It is designed to activate the immune system locally to fight cancer cells.
About the Study
OVATION 2 evaluated IMNN-001 delivered intraperitoneally alongside neoadjuvant and adjuvant chemotherapy in women with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients in the IMNN-001 arm could receive up to 17 weekly doses of the therapy in addition to chemotherapy. The study was not powered for statistical significance but assessed safety, dosing, biological activity, and multiple clinical response measures.
Updated Results Show Stronger Survival Benefits
Final data from the 112-patient OVATION 2 trial showed:
-A 14.7-month improvement in median overall survival (45.1 vs. 30.4 months) for women receiving IMNN-001 plus chemotherapy.
- A 24.2-month improvement (65.6 vs. 41.4 months) for women who also received PARP inhibitors as maintenance therapy.
Doctors leading the study said the results are especially meaningful because standard ovarian cancer treatments have seen no major advances in 30 years. IMNN-001 also continued to show a favorable safety profile.
Phase 3 Trial Progressing Ahead of Plan
IMUNON's pivotal Phase 3 OVATION 3 trial is now enrolling patients and uses overall survival as the primary endpoint. The study includes two planned interim analyses that could allow for an earlier FDA submission if results are strong. The company expects to enroll about 80 patients- roughly 20% of the total 500-patient target- within the next year.
IMNN closed Tuesday's trading at $2.94, down 1.34%. In pre-market the stock is at $2.60, down 11.56%.
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