Dynavax Completes Enrollment of Clinical Trial Evaluating HEPLISAV-B in Patients Undergoing Hemodialysis
June 09 2020 - 08:00AM
Dynavax Technologies Corporation (Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines, today announced it has completed enrollment of 119
patients in the clinical trial evaluating HEPLISAV-B® [Hepatitis B
Vaccine (Recombinant), Adjuvanted] in adults with end-stage renal
disease (ESRD) who are initiating or undergoing hemodialysis. The
Company anticipates final immunogenicity study data in the fourth
quarter of 2020.
“Completing patient enrollment for this study is a significant
milestone for our company,” commented Robert Janssen, MD, Chief
Medical Officer at Dynavax. “We are evaluating a 4-dose regimen of
HEPLISAV-B in this study, which we believe may provide an important
hepatitis B vaccination alternative for adults with end-stage renal
disease on dialysis. We look forward to a scientific presentation
of the final data at an appropriate forum in the future.”
The study, HBV-24, is an 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 HEPLISAV-B’s immunogenicity 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 BHepatitis 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-BHEPLISAV-B is an adult
hepatitis B vaccine that combines hepatitis B surface antigen with
Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018
to enhance the immune response. Dynavax has worldwide commercial
rights to HEPLISAV-B.
Indication and UseHEPLISAV-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 DynavaxDynavax is a commercial stage
biopharmaceutical company developing and commercializing novel
vaccines. The Company launched its first commercial product,
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in
February 2018, following U.S. FDA approval 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 and pertussis. 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
the timing of completion of our clinical study assessing 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. 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
Relationsnarndt@dynavax.com510-665-7264
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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