Dynavax reports Heplisav data
Dynavax Technologies Corp. (NASDAQ:DVAX) said Heplisav met the primary and secondary immunogenicity endpoints of non-inferiority and superiority to Engerix-B in the proportion of subjects achieving a seroprotective immune response in a Phase III trial to prevent HBV infection. However, in a lot-to-lot consistency analysis of three consecutively manufactured lots of Heplisav, the vaccine missed the pre-specified consistency criteria as measured by both geometric mean antibody concentration and seroprotection rates at eight weeks after the last dose. It did meet the criteria for both consistency measurements at weeks 12, 18, 24 and 28. The product is a hepatitis B surface antigen (HBsAg) given with immunostimulatory DNA sequences (ISS) that target toll-like receptor 9 (TLR9). The trial enrolled 2,449 healthy volunteers ages 40-70.
Detailed results will be presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago in September. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) markets Engerix-B to treat HBV infection. ...