Imunon’s shares soared by 180% yesterday (30 July) following positive data from the Phase II trial of interleukin (IL)-12 immunotherapy plus chemotherapy in ovarian cancer patients.
The OVATION-2 study randomised 112 patients with advanced ovarian cancer to receive the IL-12 immunotherapy called IMNN-001, plus chemotherapy or standard-of-care chemotherapy alone. The combination led to an 11.1-month benefit in median overall survival (OS) in the intent-to-treat cohort. The study was not powered for statistical significance.
On the trial’s primary endpoint of progression-free survival (PFS), IMNN-001 plus chemotherapy resulted in a three-month improvement versus chemotherapy alone. According to New Jersey-based Imunon, the company now plans to hold an end-of-Phase II meeting with the US Food and Drug Administration (FDA) to discuss the protocol for a Phase III study, which is anticipated to begin in Q1 2025.
IMNN-001 comprises an IL-12 DNA plasmid vector encapsulated in a nanoparticle vehicle. IL-12 is a cytokine that plays a crucial role in the immune response, particularly in enhancing the activities of natural killer cells and T lymphocytes, which are important for attacking cancer cells.
The IL-12-based therapy has demonstrated efficacy in studies as a cancer immunotherapy. However, its clinical use has been plagued by significant immune-related side effects. According to Imunon’s chief medical officer Sebastien Hazard, the safety profile of IMNN-001 is tolerable.
Imunon is not the only player exploring IL-12 therapeutics. In March 2024, US pharma giant Gilead Sciences teamed up with Xilio Therapeutics to advance the latter’s IL-12 candidate XTX301 through clinical development. The deal included $43.5m in upfront payments and up to $604m from Gilead Sciences in additional payments. XTX301 is currently being evaluated in an ongoing Phase I clinical trial (NCT05684965).
In the announcement accompanying the data release, Imunon’s CEO Stacy Lindborg said: “These strong and clinically meaningful Phase II results are highly encouraging, suggesting that IMNN-001 may improve the outcomes for women with advanced ovarian cancer. In the near term, we look forward to advancing our therapeutic into a Phase III pivotal study as soon as possible.”
GlobalData estimates that the ovarian cancer market in the seven major pharmaceutical markets (7MM) (US, France, Germany, Italy, Spain, UK, and Japan) in 2022 was $3.3bn in 2023. By 2032, GlobalData forecasts ovarian cancer drug sales to reach $4.1bn for the 7MM at a compound annual growth rate (CAGR) of 2%.
GlobalData is the parent company of Pharmaceutical Technology.
