Dynavax’ production facility in Düsseldorf, Germany, received European regulatory clearance for the commercial production of hepatitis B surface antigen. The antigen is a key component of the company’s Phase III adult hepatitis B vaccine, Heplisav™.
Dynavax’ German subsidiary, Rhein Biotech, has been manufacturing the hepatitis B surface antigen for Heplisav clinical trials at the Düsseldorf facility since 2006. The new license means the facility should be able to meet initial commercial production demands.
Heplisav is Dynavax’ lead product. The vaccine combines hepatitis B surface antigen with a toll-like receptor 9 (TLR9) agonist to enhance immune response. Dynavax says that Heplisav has been designed to provide faster and better protection against HBV, using fewer doses than currently licensed vaccines.
The company is developing the vaccine primarily for populations that are less responsive to other vaccines, including adults over 40 years of age and those with chronic kidney disease. Heplisav has already completed one Phase III trial, and in September Dynavax began vaccinating chronic kidney disease patients in another Phase III study. A third Phase III lot-to-lot consistency trial in patients aged 40 years and over is expected to begin in early 2010. Progression of clinical trials in renal disease patients had been placed on hold by FDA since 2008, following the agency’s request for additional safety data. This hold was lifted this September.
In October Dynavax reported initial clinical data from two single-blind, randomized studies including 87 subjects over 40 years of age who demonstrated progressive loss of renal function. The data showed that vaccinating chronic kidney disease patients with Heplisav resulted in rapid, increased protection against HBV infection, using fewer doses, than a currently licensed vaccine. Ninety six percent of patients receiving three doses of Heplisav achieved seroprotection at month seven, compared with 88% of patients receiving eight doses of Engerix-B®.