Dynavax Technologies Corp. (DVAX) commenced a new phase III study (HBV-23) on its hepatitis B vaccine candidate, Heplisav-B. Dynavax is seeking to get Heplisav-B approved in the U.S. and EU.
The randomized, active-controlled, HBV-23 (n=8,000) study will randomize (2:1) patients to receive a 2-dose series of Heplisav-B and 3-dose series of GlaxoSmithKline’s (GSK) Engerix-B.
The primary endpoints of the study are for evaluation of the overall safety of the candidate and demonstrate the non-inferiority of the seroprotection rate induced by Heplisav-B compared with Engerix-B at week 28 in type II diabetes patients.
Secondary endpoints include safety profile of Heplisav-B with respect to specific outcomes and assessment of immunogenicity in subpopulations.
HBV-23 is a large safety and immunogenicity study, which is designed to address the complete response letter (CRL) issued in Feb 2013. This study will provide safety database that will be adequate to support licensure. This study is expected to complete enrolment by the end of 2014, with follow-up likely to be completed by the fourth quarter of 2015.
Dynavax faced hindrances both in the U.S. and Europe in getting Heplisav-B approved. We note that Dynavax suffered a setback in Jun 2013 when the U.S. Food and Drug Administration (:FDA) asked for additional safety data in response to a meeting with the agency to discuss the CRL received earlier in 2013 on Heplisav-B.
In Feb 2014, Dynavax withdrew its MAA for Heplisav-B as the Day 180 List of Outstanding Issues provided by the EMA suggested that the current safety database for Heplisav-B is too small to rule out a risk of less common serious adverse events. Dynavax decided to withdraw its MAA as the required time period for response under the regulatory process is not adequate to collect the clinical data.
Dynavax does not have any marketed product in its portfolio. We expect investor focus to remain on Heplisav-B.