EMERYVILLE, Calif.,
Jan. 7, 2021 /PRNewswire/
-- Dynavax Technologies Corporation (Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
vaccines, today announced final immunogenicity and interim safety
results of the ongoing clinical trial evaluating
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted] in patients undergoing hemodialysis.
Final immunogenicity data in 119 patients in this clinical trial
evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage
renal disease (ESRD) undergoing hemodialysis, demonstrated a
seroprotection rate of 89.3% with high levels of anti-HBs
antibodies, which are critical to maintain protection in patients
undergoing hemodialysis. Interim safety data showed HEPLISAV-B
is well tolerated and no safety concerns were observed. Full safety
data are expected by the end of 2021.
"We are pleased with these positive results from the ongoing
hemodialysis trial which reinforce the existing clinical data
regarding the safety and ability of HEPLISAV-B to provide high
rates of protection," commented Robert
Janssen, MD, Chief Medical Officer at Dynavax. "We believe
the 4-dose regimen of HEPLISAV-B, we are evaluating in this study,
can provide an important hepatitis B vaccination alternative for
patients undergoing hemodialysis by delivering high levels of
protection with fewer doses compared to the current standard of
care which requires up to 8 injections to complete the
regimen."
The study, HBV-24, is an ongoing, open-label, single-arm trial
being conducted in the United
States to evaluate a new 4-dose regimen of
HEPLISAV-B in adults with ESRD who are undergoing hemodialysis
and have not previously received a hepatitis B vaccine. The study
is designed to evaluate the immunogenicity of HEPLISAV-B at study
week 20 and safety over the 68-week study duration. Safety and
effectiveness of HEPLISAV-B have not been established in adults on
hemodialysis.
Please see Important Safety Information below.
For more information about HEPLISAV-B, visit
http://heplisavb.com
About Hepatitis B
Hepatitis B is a viral disease of
the liver that can become chronic and lead to cirrhosis, liver
cancer and death. The hepatitis B virus is 50 to 100 times more
infectious than HIV,i and transmission is on the rise.
There is no cure for hepatitis B, but effective vaccination can
prevent the disease.
In adults, hepatitis B is spread through contact with infected
blood and through unprotected sex with an infected person. The U.S.
Centers for Disease Control (CDC) recommends vaccination for those
at high risk for infection due to their jobs, lifestyle, living
situations and travel to certain areas.ii Because people
with diabetes are particularly vulnerable to infection, the CDC
recommends vaccination for adults age 19 to 59 with diabetes as
soon as possible after their diagnosis, and for people age 60 and
older with diabetes at their physician's discretion.iii
Approximately 20 million U.S. adults have diabetes, and 1.5 million
new cases of diabetes are diagnosed each year.iv
About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B
vaccine that combines hepatitis B surface antigen with Dynavax's
proprietary Toll-like Receptor (TLR) 9 agonist adjuvant CpG 1018 to
enhance the immune response. Dynavax has worldwide commercial
rights to HEPLISAV-B.
Indication and Use
HEPLISAV-B is indicated for prevention of infection caused by all
known subtypes of hepatitis B virus in adults age 18 years and
older.
Important Safety Information (ISI)
Do not administer
HEPLISAV-B to individuals with a history of severe allergic
reaction (e.g., anaphylaxis) after a previous dose of any hepatitis
B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to
manage possible anaphylactic reactions following administration of
HEPLISAV-B.
Immunocompromised persons, including individuals receiving
immunosuppressant therapy, may have a diminished immune response to
HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not
prevent hepatitis B infection in individuals who have an
unrecognized hepatitis B infection at the time of vaccine
administration.
The most common patient reported adverse reactions reported within
7 days of vaccination were injection site pain (23% to 39%),
fatigue (11% to 17%) and headache (8% to 17%).
For full Prescribing Information for HEPLISAV-B, click here
About Dynavax
Dynavax is a commercial stage
biopharmaceutical company developing and commercializing novel
vaccines. The Company's first commercial product, HEPLISAV-B®
[Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the
U.S. for prevention of infection caused by all known subtypes of
hepatitis B virus in adults age 18 years and older. Dynavax is also
advancing CpG 1018 as a premier vaccine adjuvant through research
collaborations and partnerships. Current collaborations are focused
on adjuvanted vaccines for COVID-19, pertussis and universal
influenza. For more information, visit www.dynavax.com and follow
the company on LinkedIn.
Forward-Looking Statements
This press release contains
forward-looking statements, including statements regarding use of
HEPLISAV-B in adults undergoing hemodialysis. These
statements are subject to a number of risks and uncertainties that
could cause actual results to differ materially, including whether
and when the clinical study will be completed and what the final
results will reflect, and whether additional studies will be
required to demonstrate safety and effectiveness of HEPLISAV-B in
person's undergoing hemodialysis, and if further studies are
required, when they would be completed and what the results will
reflect. For a further description of the risks and uncertainties
that could cause actual results to differ from those expressed in
these forward-looking statements, as well as risks relating to the
business of Dynavax in general, see risks detailed in the
"Risk Factors" section of our most recent current periodic report
filed with the SEC. These statements represent our estimates
and assumptions only as of the date of this press release. We do
not undertake any obligation to update publicly any such
forward-looking statements, 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
Contacts:
Nicole Arndt, Senior Manager,
Investor Relations
narndt@dynavax.com
510-665-7264
Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
i CDC.
https://www.cdc.gov/hepatitis/hbv/bfaq.htm.
ii CDC.
https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.
iii CDC.
https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.
iv CDC.
https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
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SOURCE Dynavax Technologies