Dynavax Technologies has met with the European Medicines Agency (EMEA) to discuss its plans to continue the clinical development of Hepislav, an investigational hepatitis B vaccine.
Dynavax has proposed to develop Hepislav for adults that are less responsive to licensed hepatitis B vaccines, including adults over 40 years of age, individuals with chronic kidney disease and other groups.
In response, the EMEA expressed a general agreement with Dynavax's proposed plan and also suggested that the drug development be extended for adults under 40 years of age who need rapid protection, a group that includes emergency personnel, healthcare workers and international travellers.
Dynavax president and chief executive officer Dino Dina said that the vaccine could transform vaccination regimens and outcomes, particularly for individuals with increased risk of infection.
Hepislav is a Phase III investigational adult hepatitis B vaccine designed to provide more rapid and increased protection with fewer doses than already licensed vaccines.
Over 2,500 individuals have been vaccinated with Hepislav to date.
Dynavax has worldwide commercial rights to Hepislav, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like receptor 9 agonist to enhance the immune response.