The dose escalation study assessed safety and the immunologic and virologic responses in 14 subjects with chronic hepatitis B infection. The Phase 1b data showed:
• All doses were generally safe and well tolerated; and
• Individual immunologic and virologic responses were observed across cohorts at all dose levels.
No conclusions regarding the potential clinical impact of the therapy could be reached in this small study. Dynavax's treatment approach combines both the surface and core hepatitis B virus (HBV) antigens with ISCOMATRIX® adjuvant originally entered into development by Rhein Biotech prior to its acquisition by Dynavax in 2006. The candidate vaccine, DV-601, is designed to induce an immune response against HBV-infected cells and if proven to be safe and effective, may offer an alternative therapeutic option for patients chronically infected with HBV.