Neoantigen Vaccine + IL-12 for Liver Cancer

(IMPACT31 Trial)

This trial explores a new personalized vaccine treatment for individuals with liver cancer who have undergone surgery. The goal is to determine if the vaccine, combined with IL-12 (an immune system booster), can help prevent cancer recurrence. Participants must have liver cancer confirmed through tests and must have had surgery with no current signs of the disease. The trial involves regular treatments with the vaccine and IL-12 over several years, compared to monitoring the patient. It is suitable for those who can provide a tissue sample from their tumor and are willing to adhere to the treatment schedule. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial does not specify if you need to stop taking your current medications. However, you cannot be on systemic steroid therapy or any other immunosuppressive therapy within 7 days before starting the study drug.

Research has shown that the GNOS-PV02 vaccine, combined with INO-9012, has undergone safety testing in people. The most common side effect occurred at the injection site, affecting about 42% of participants. Importantly, no severe side effects halted dosage increases, suggesting the treatment is generally well-tolerated. Additionally, some patients experienced a decrease in cancer markers, indicating the treatment's potential effectiveness alongside its safety.¹²³⁴⁵

Researchers are excited about the treatment using GNOS-PV02 and INO-9012 for liver cancer because it represents a cutting-edge approach called personalized immunotherapy. Unlike standard treatments like surgery, chemotherapy, or radiation, which broadly target cancer cells, this treatment harnesses the body's immune system to specifically target neoantigens—unique markers on cancer cells. Additionally, the use of electroporation to deliver the treatment enhances the uptake of the vaccine, potentially increasing its effectiveness. By focusing on these specific cancer markers, this approach aims to provide a more precise and potentially more effective treatment option for liver cancer patients.

In this trial, participants will receive either the combination of the GNOS-PV02 vaccine and INO-9012 or the standard of care. Research has shown that this combination may help treat liver cancer. Specifically, studies found that 40.7% of patients experienced a reduction of at least 50% in circulating tumor DNA (ctDNA), suggesting the treatment might effectively target cancer cells. The vaccine uses personalized neoantigens, unique markers on cancer cells, to train the immune system to attack the cancer. This method aims to help the body recognize and fight the cancer more effectively. While early results are promising, more research is needed to confirm its effectiveness in a wider range of patients.¹²³⁴⁶