Imunon (IMNN) Study Result summary

Study design and patient population

• OVATION-2 was a randomized, open-label Phase II trial evaluating IMNN-001 plus neoadjuvant/adjuvant chemotherapy in newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer patients.

• 112 patients were enrolled and randomized 1:1 to receive standard chemotherapy with or without IMNN-001, with up to 17 weekly doses of IMNN-001 administered intraperitoneally using TheraPlas technology.

• The study assessed dosing, safety, efficacy, and biological activity, with primary endpoints including progression-free survival (PFS) and overall survival (OS).

• IMNN-001 is an IL-12 DNA plasmid vector designed for local immune modulation in the peritoneal cavity.

Efficacy and survival outcomes

• IMNN-001 showed an 11.1-month improvement in median OS (40 vs. 29 months) in the intent-to-treat population, a clinically meaningful benefit.

• Patients receiving at least 20% of protocol-specified treatments or three or more doses had a 15.7-month OS improvement and a 56% survival benefit (hazard ratio 0.64).

• In patients treated with PARP inhibitors, the hazard ratio for OS dropped to 0.41, with median OS not reached in the IMNN-001 arm.

• PFS improved by 3 months in the ITT population (hazard ratio 0.79), and by 11.7 months in those receiving first-line PARP inhibitors.

Safety and tolerability

• IMNN-001 demonstrated a highly encouraging and tolerable safety profile, with most common adverse events being manageable gastrointestinal symptoms.

• Safety was monitored by a DSMB and deemed very tolerable throughout the study.