Dynavax Technologies Corp. (NASDAQ: DVAX) led the bulls on Thursday with positive results from a late stage clinical trial, on another consecutive down day for the broad markets. The reported preliminary top-line results from HBV-23, a Phase 3 trial of the safety and immunogenicity of its investigational hepatitis B vaccine, Heplisav-B, compared with a currently marketed vaccine, Engerix-B.
Heplisav-B participants received two doses, at zero and one month, and Engerix-B participants received three doses, at zero, one and six months. Both co-primary endpoints were met. The rates of clinically significant adverse events were consistent with randomization and similar to rates in prior trials, and Heplisav-B provided a statistically significant higher rate of seroprotection than Engerix-B in diabetic participants and in all participants as a group.
Eddie Gray, CEO of Dynavax, commented:
We are delighted to report these topline results from HBV-23 and confirm our intention to resubmit the HEPLISAV-B BLA by the end of March. These results support our belief that HEPLISAV-B, if approved, could offer benefits to adults at risk for hepatitis B, particularly given that these significant differences in seroprotection were demonstrated in a controlled setting, where compliance is optimized.
Robert Janssen, chief medical officer, added:
These topline results are consistent with our expectations. With regard to the principal safety focus, Adverse Events of Special Interest, the results reflect a distribution consistent with randomization. To see such statistically significant differences in immunogenicity so consistently and across all groups and patient subsets, confirms the potential of HEPLISAV-B for people in need of protection.
Dynavax plans to resubmit the Heplisav-B Biologics License Application (BLA) at the end of the first quarter of 2016 and anticipates a six-month review by the FDA.
Shares of Dynavax were trading up 26.3% at $26.75 on Thursday, with a consensus analyst price target of $46.25 and a 52-week trading range of $15.80 to $32.49.