�Dynavax Technologies Corporation (Nasdaq:DVAX) and Merck & Co., Inc. announced today top-line immunogenicity results from a Phase 3 clinical trial comparing HEPLISAV�, an investigational hepatitis B virus (HBV) vaccine, to a presently marketed HBV vaccine, Engerix-B� (1). The study achieved its master endpoint. HEPLISAV is beingness jointly developed by Dynavax and Merck for use in adults and in patients with end stage renal disease.
This study, called PHAST (Phase 3 HeplisAv Short-regimen Trial), evaluated a two-dose regimen of HEPLISAV administered at 0 and 1 month compared to a three-dose regimen of Engerix-B� administered at 0, 1 and 6 months. The primary endpoint was the proportion of subjects wHO developed protective antibodies to hepatitis B after government. In PHAST, 95.1 percent of subjects world Health Organization received deuce doses of HEPLISAV (n=1,819) developed protective antibodies to hepatitis B when measured at 12 weeks versus 81.1 percent of subjects who received three doses of Engerix-B� (n=608) when measured at 28 weeks. The multi-center study evaluated 2,427 subjects from 11 to 55 age of age in Canada and Germany. Results of additional analyses from this trial will be presented in the future.
As previously disclosed, the U.S. Food and Drug Administration (FDA) set a clinical hold on the iI Investigational New Drug (IND) Applications for HEPLISAV that is quiet in effect. In issuing the clinical hold, the FDA requested a review of clinical and presymptomatic safety data for HEPLISAV. Additionally, the FDA requested all uncommitted information around a single case of Wegener's granulomatosis reported in this Phase 3 trial.
HEPLISAV is based on Dynavax's proprietary immunostimulatory episode (ISS) that specifically targets Toll-Like Receptor 9 (TLR9) to induce an innate immune reply. HEPLISAV combines ISS with HBV surface antigen (HBsAg) and is designed to enhance the speed of protection.
About Dynavax Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and keep infectious diseases, allergy, malignant neoplastic disease, and chronic inflammatory diseases using various, proprietary approaches that modify immune organization responses in highly specific ways. Our TLR9 agonists are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the power of the immune system to fight disease and control chronic inflammation. Our clinical intersection candidates include: HEPLISAV, a hepatitis B vaccine partnered with Merck & Co., Inc.; a therapy for metastatic colorectal cancer; and therapies for hepatitis B and C. Our presymptomatic asthma and COPD
