California Biotech Collaboration Explores Functional Chronic Hepatitis B Virus Cure
California-based Gilead Sciences, Inc. and Vir Biotechnology, Inc. announced that the companies have entered into a clinical collaboration to evaluate novel therapeutic combination strategies to develop a functional cure for chronic hepatitis B virus (HBV), which affects more than 290 million people worldwide.
The companies stated they plan to initiate a Phase 2 trial evaluating combination therapy for both treatment-experienced and treatment-naïve people living with HBV. The multi-arm trial will evaluate different combinations of selgantolimod, Gilead’s investigational TLR-8 agonist; VIR-2218, Vir’s investigational small interfering ribonucleic acid (siRNA); and a commercially-sourced, marketed PD-1 antagonist.
The safety and efficacy of selgantolimod and VIR-2218 have not been established. They are investigational compounds, not approved by the U.S. FDA or any other regulatory authority.
Phil Pang, M.D., Ph.D., Chief Medical Officer of Vir Biotechnology, stated in a press release, “We believe a functional cure for the majority of patients will require a reduction of the levels of circulating viral proteins together with an immune boost to stimulate the production of new T-cells that can bring the infection under control."