HepB mAb19

HepB mAb19 is a novel human monoclonal antibody being developed for the treatment of chronic hepatitis B infection. It targets the hepatitis B surface antigen (HBsAg), specifically binding to the "a-determinant" of the extracellular loop of HBsAg (also referred to as the S-protein). It has shown exceptional neutralizing activity against HBV in preclinical studies and is currently being evaluated in Phase 1 clinical trials. The drug was initially developed by NYU Langone Health and is now being studied in a first-in-human, placebo-controlled, single-dose, dose-escalation Phase 1 study (NCT05856890). This study aims to evaluate the safety, pharmacokinetics, and antiviral activity of HepB mAb19 in individuals with chronic hepatitis B who are already on nucleos(t)ide analog therapy (NRTI). HepB mAb19 has cross-reactivity to all four major HBsAg serotypes and demonstrated exceptional in vitro neutralizing activity with an IC50 of 5.1 ng/mL. It has been engineered for a prolonged half-life with an LS mutation in the Fc domain.