Dynavax Technologies Corp.
) 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
) patients to receive a 2-dose series of Heplisav-B and 3-dose
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
Secondary endpoints include safety profile of Heplisav-B with
respect to specific outcomes and assessment of immunogenicity in
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
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.
Dynavax carries a Zacks Rank #2 (Buy). Others stocks that look
Sucampo Pharmaceuticals, Inc.
). Both of these sport a Zacks Rank #1 (Strong Buy).
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