First Patient Receives Phase 1 Clinical Trial Dose of FS118
The clinical trial for an antibody designed to treat advanced cancers has begun with the first dose of FS118. The treatment is supposed to target two immune checkpoint proteins. The study, based in the US, will be enrolling 51 patients who have been diagnosed with metastatic cancers. The patients have not previously responded to the traditional treatments offered. Researchers are evaluating several aspects of FS118 including its stability, tolerability, safety and how it functions therapeutically when the antibody is administered in ascending doses. The ultimate goal is to identify the appropriate dosage to use in the next phase of testing.
Administering the Clinic Trial
During Phase 1 of the clinical study of FS118, patients receive weekly injections of the antibody in three-week cycles. The injections are given until the patient shows signs of disease progression or toxicity. The antibody inhibits PD-L1 and LAG-3 molecules simultaneously. Recent studies have demonstrated that inhibiting PD-1 and PD-L1 molecules may help defeat various cancers. However, there are many people whose bodies do not respond to the inhibitors and the disease returns later on. Some experts believe this type of resistance might be caused by LAG-3 on some of the immune T-cells. Therefore, treating affected patients with antibodies that fight PD-1 and LAG-3 might provide better outcomes for relapsed patients or those who do not respond favorably to PD-1 and PD-L1 inhibitors. The difference in FS118 is that it is a bispecific antibody, or one that targets both of these molecules at the same time. In a study done using mice as the subjects, FS118 performed better at activating anti-cancer T-cells than when a PS-L1 inhibitor was used alone. It was more effective at inducing tumor responses similar to the combination of anti-PD-L1 and anti-LAG-3 antibodies.
The initiation of the first phase of the trial was supported in research presented at the 2018 AACR meeting (American Association of Cancer Research) in Chicago. The presentation discussed how only about 20% of cancer patients treated with single inhibition therapy. The hope is that FS118 will increase the rate at which patients overcome tumor resistance while also helping restore the immunity to cancer.