The ONCOS-102 immunotherapy vaccine was given the Fast-Track Designation, which will speed up regulatory approval. The vaccine is used to treat mesothelioma and other cancers. Targovax, which developed the treatment, is taking this as an endorsement from the FDA. Targovax is a small biotech company that mainly works with oncolytic viruses. The company believes that the designation will help get the treatment approved and more widely distributed for patients struggling with cancer.
Results from a Phase II clinical trial show that there is an increased survival for patients who are administered the vaccine alongside chemotherapy. The median overall survival for patients given the treatment was 20.5 months compared to the control group which was 13.5 months for patients just receiving chemotherapy. Researchers found that the ONCOS-102 vaccine had a broad immune system activation and was safe and tolerable for patients. A follow up study is expected to occur next year with the survival projected to be higher in the people taking chemotherapy and the vaccine. The most recent treatment to be approved for mesothelioma is the combination of Opdivo and Yervoy, which was the first time in 16 years that a treatment was approved for treating mesothelioma.
With the fast track designation, Targovax will have more contact with the FDA, more resources available from the agency, and a priority review status which helps shorten the time it takes to be approved. The fast-track designation is typically used for new drugs that help treat diseases that are hard to treat without a cure. There is no cure for mesothelioma and the most effective treatment for the disease is aggressive surgery, but not many patients qualify for surgery (only 1/3 qualify). ONCOS-102 also has the Orphan Drug Designation, which lets doctors treat patients that have rare diseases before it is fully approved.
ONCOS-102 will be part of another clinical trial, this time with the immunotherapy drug Keytruda (pembrolizumab). The companies believe that the drugs will work together to fight mesothelioma. Keytruda was recently approved for a small amount of mesothelioma patients with high levels of the PD-1 protein. Keytruda has had great results with a small number of patients, but the positive effects do not last. It is believed that ONCOS-102 can make tumors more sensitive to Keytruda.
ONCOS-102 is Targovax’s main product. It is a modified adenovirus that infects cancer cells and activates the immune system. It is also being tested on colorectal cancer and melanoma. The upcoming trial will have more than 100 patients across 10 different cancer centers in the United States. The study is comparing ONCOS-102, Keytruda, and chemotherapy to just Keytruda and chemotherapy.
