Dynavax Reports Interim Analysis of Ongoing Clinical Trial Evaluating HEPLISAV-B in Patients Undergoing Hemodialysis
April 28 2020 - 4:10PM
Dynavax Technologies Corporation (Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines, today reported immunogenicity and safety data from
an interim analysis of the ongoing clinical trial evaluating
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] in
patients undergoing hemodialysis. This data was chosen for oral
presentation at the National Foundation for Infectious Diseases
(NFID) 2020 Annual Conference on Vaccinology Research (ACVR), a
premier forum for the exchange of scientific and clinical knowledge
in vaccinology, which was cancelled due to COVID-19.
Interim analysis of safety data in 70 patients in this clinical
trial evaluating a 4-dose regimen of HEPLISAV-B in adults with
end-stage renal disease (ESRD) who are initiating or undergoing
hemodialysis, showed HEPLISAV-B was well tolerated with a
seroprotection rate of 86.4% in 44 patients. Full study data are
anticipated in the second half of 2020.
“We are pleased with these interim results from the hemodialysis
trial which reinforce the existing clinical data set regarding the
safety and rates of protection provided by HEPLISAV-B,” commented
Robert Janssen, MD, Chief Medical Officer at Dynavax. “We are
evaluating a 4-dose regimen of HEPLISAV-B in this study, which
contrasts with the 8-dose regimen required by the legacy product
and look forward to a scientific presentation of the final data at
an appropriate forum in the future.”
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 end-stage renal disease
(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 a 4-dose
regimen of HEPLISAV-B have not been established in adults on
hemodialysis.
Webcast InformationAs a result of the
cancellation of the NFID ACVR, Randall N. Hyer, MD, PhD, MPH, Vice
President, Clinical Development and Medical Affairs at Dynavax will
host a webinar review of the interim analysis data this Thursday,
April 30, 2020 at 1:00 p.m. ET/10:00 a.m. PT. The live audio
webcast may be accessed through the “Events & Presentations”
page on the “Investors” section of the Company’s website at
www.dynavax.com.
To view this poster and the additional Dynavax submission that
was also selected for presentation at ACVR titled “Consideration of
Effective Seroprotection Rate and Cost Per Protected Patient as
Estimates of Real-World Outcomes in Adult Hepatitis B Virus (HBV)
Vaccination,” please visit the Publications & Presentations
section of our website at
https://www.dynavax.com/science/publications-presentations/.
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 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 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 an advanced vaccine adjuvant through
research collaborations and partnerships. 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. 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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