Dynavax Technologies Corporation (Nasdaq:DVAX) today announced that it has met with the European Medicines Evaluation Agency (EMEA) to discuss its plans for continued clinical development of HEPLISAV Phase 3 investigational adult hepatitis B vaccine in Europe.
In a Scientific Advice letter, EMEA expressed a general agreement with Dynavax’s proposed plan to develop HEPLISAV for adult populations that are less responsive to current licensed hepatitis B vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and other groups. In addition, EMEA suggested that Dynavax consider the development of HEPLISAV for adults under 40 years of age who need rapid protection, a group that includes emergency personnel, healthcare workers and international travelers.
“As we advance our development plans for HEPLISAV, EMEA’s scientific advice supports expansion of our targeted population in Europe to include subjects who need rapid protection against hepatitis B infection,” commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. “A vaccine that demonstrates potential to provide faster and better protection than current vaccines could transform vaccination regimens and outcomes, particularly for individuals with increased risk of infection.”
About HEPLISAV
HEPLISAV is a Phase 3 investigational adult hepatitis B vaccine designed to provide more rapid and increased protection with fewer doses than current licensed vaccines. Over 2,500 individuals have been vaccinated with HEPLISAV to date.
Dynavax has worldwide commercial rights to HEPLISAV, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
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