Dynavax Initiates Phase 3 Study of HEPLISAV-B(TM)

Dynavax Initiates Phase 3 Study of HEPLISAV-B(TM) 
BERKELEY, CA -- (Marketwired) -- 04/15/14 --  Dynavax Technologies
Corporation (NASDAQ: DVAX) today announced initiation of a new phase
3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B
vaccine. This large safety and immunogenicity study (known as HBV-23)
was designed to address the Complete Response Letter regarding the
HEPLISAV-B Biologics License Application that was issued to Dynavax
by the U.S. Food and Drug Administration in February, 2013. 
HBV-23 will provide greater clarity regarding the safety profile of
HEPLISAV-B by significantly expanding the overall database of
vaccinated subjects. The study will also assess the immunogenicity of
HEPLISAV-B in subjects for whom approved hepatitis B vaccines are
less effective. Dynavax expects that all study subjects will be
enrolled by the end of 2014 and all follow-up will be completed by
the fourth quarter of 2015. 
HBV-23 Study Design 
HBV-23 is an observer-blinded, randomized, active-controlled, trial
being conducted at approximately 40 sites in the U.S. Approximately
8,250 adult subjects between the ages of 18 and 70 will be randomized
in a 2:1 ratio to receive a 2-dose series of HEPLISAV-B or a 3-dose
series of a control vaccine, Engerix-B(R). Enrollment will be
stratified by site, age group and type 2 diabetes mellitus status.
Safety follow-up will continue for all subjects through study week
56. 
The co-primary objectives of HBV-23 are to: 


 
--  Evaluate the overall safety of HEPLISAV-B with respect to clinically
    significant adverse events (AEs), and
--  Demonstrate the noninferiority of the seroprotection rate induced by
    HEPLISAV-B compared with Engerix-B at Week 28 in subjects with type 2
    diabetes mellitus.

  
The study also includes multiple secondary objectives intended to
further elucidate the safety profile of HEPLISAV-B with respect to
specific outcomes and to assess its immunogenicity in subpopulations
including smokers, men, individuals with higher body mass, and those
aged 40 years and older. 
All AEs from HBV-23 that are considered to represent potential
autoimmune disorders will be reviewed by an independent Safety
Evaluation and Adjudication Committee (SEAC). The SEAC will provide
an opinion whether each event is autoimmune in origin, pre-existing
or new-onset, and related or not related to study treatment. The full
safety dataset will be reviewed periodically by an independent Data
and Safety Monitoring Board (DSMB) to ensure the safety of subjects
and scientific integrity of the study. The DSMB will perform at least
three prespecified reviews. 
Additional details regarding HBV-23 are available at
www.clinicaltrials.gov. 
About HEPLISAV-B 
HEPLISAV-B is an investigational adult hepatitis B vaccine that
combines hepatitis B surface antigen with a proprietary Toll-like
Receptor 9 agonist to enhance the immune response. Dynavax has
worldwide commercial rights to HEPLISAV-B. 
About Dynavax 
Dynavax, a clinical-stage biopharmaceutical company, discovers and
develops novel vaccines and therapeutics in the areas of infectious
and inflammatory diseases and oncology. Dynavax's lead product
candidate is HEPLISAV-B, a Phase 3 investigational adult hepatitis B
vaccine. For more information visit www.dynavax.com. 
Forward-Looking Statements 
This press release contains "forward-looking" statements, including
expectations for the conduct, timing and sufficiency of an additional
clinical trial for HEPLISAV-B. Actual results may differ materially
from those set forth in this press release due to the risks and
uncertainties inherent in our business, including whether successful
clinical and regulatory development and review and approval of
HEPLISAV-B and our process for its manufacture can occur without
significant delay or additional studies; whether our studies and
manufacturing efforts are sufficient to support registration for
commercialization of HEPLISAV-B in either or both of the US and
Europe; the timing for and costs of achieving the size of the safety
database; the results of clinical trials and the impact of those
results on the initiation and completion of subsequent trials and
issues arising in the regulatory process, including whether a US or
European licensure application will be approved; our ability to
obtain additional financing to support the development and
commercialization of HEPLISAV-B and our other operations; possible
claims against us, including enjoining sales of HEPLISAV-B, based on
the patent rights of others; and other risks detailed in the "Risk
Factors" section of our current periodic reports with the SEC. We
undertake no obligation to revise or update information herein to
reflect events or circumstances in the future, even if new
information becomes available. Information on Dynavax's website at
www.dynavax.com is not incorporated by reference in our current
periodic reports with the SEC. 
Contact:
Michael S. Ostrach
Vice President, Chief Business and Principal Financial Officer 
510-665-7257
mostrach@dynavax.com 
 
 
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