IMUNON Inc ( IMNN ) stock is surging on Tuesday, with a strong session volume of 117.8 million as per data from Benzinga Pro.

The nano-cap company released topline results from the Phase 2 OVATION 2 Study with IMNN-001 in patients with advanced ovarian cancer.

OVATION 2 is a randomized study of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) inclusive of interval debulking or cytoreductive surgery compared with a control arm of standard-of-care NACT alone.

IMNN-001 is the company’s interleukin-12 (IL-12) immunotherapy based on its TheraPlas technology.

Highlights from patients treated with IMNN-001 plus standard-of-care in a first-line treatment setting include:

An 11.1-month increase in median overall survival compared with standard-of-care alone in the intent-to-treat population (ITT).

A hazard ratio in the ITT population of 0.74 indicates a 35% improvement in survival.

Among the approximately 90% of trial participants who received at least 20% of specified treatments per protocol in both study arms, patients in the IMNN-001 arm had a 15.7-month increase in median OS, representing a further extension of life with a hazard ratio of 0.64, a 56% improvement in survival.

For the nearly 40% of trial participants treated with a poly ADP-ribose polymerase (PARP) inhibitor, the hazard ratio decreased further to 0.41, with median overall survival in the IMNN-001 treatment arm not yet reached at the time of database lock, compared with the median overall survival of 37.1 months in the standard-of-care treatment arm.

The PFS results, the trial’s primary endpoint, support the OS results with:

A three-month improvement in PFS compared with standard-of-care alone.

A hazard ratio in the intent-to-treat population of 0.79, indicating a 27% improvement in delaying progression for the IMNN-001 treatment arm.

IMUNON ( IMNN ) plans to hold an End-of-Phase 2 meeting with the FDA as soon as possible to discuss the protocol for a Phase 3 study, which is anticipated to begin in the first quarter of 2025.

Price Action: IMNN stock is up 158% at $3.07 at last check Tuesday.

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