Dynavax Announces First Patient Enrolled in Study of HEPLISAV-B® [Hepatitis B Vaccine, Recombinant (Adjuvanted)] in Adults W...
May 02 2019 - 5:00PM
Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated
biopharmaceutical company focused on discovering, developing and
commercializing novel vaccines and immuno-oncology therapeutics,
today announced the enrollment of the first patient in the
company’s open-label, single-arm study of HEPLISAV-B in adults with
end-stage renal disease who are initiating or undergoing
hemodialysis.
“Although vaccination to prevent hepatitis B
infection has been standard practice for decades for dialysis
patients and healthcare workers, there remains a need to provide
improved overall protection safely through a greater and more
durable antibody response,” said Robert Janssen, M.D., chief
medical officer of Dynavax. “HEPLISAV-B consistently demonstrated
higher seroprotection rates than a comparator in head-to-head
clinical trials and we’re hopeful that this patient population may
benefit from this new and shortened dosing schedule as compared to
currently approved treatments. The initiation of this open-label
study evaluating the immunogenicity and safety of HEPLISAV-B for
patients with kidney failure is an important step in understanding
how this treatment may help this vulnerable patient
population.”
This open-label, single arm study will evaluate
HEPLISAV-B in adults with end-stage renal disease who are
initiating or undergoing hemodialysis. The primary endpoints are to
evaluate the immunogenicity induced by HEPLISAV-B at week 20 as
measured by seroprotection rate and to evaluate the safety of
HEPLISAV-B with respect to clinically significant adverse
events.
The trial will enroll approximately 100 end-stage
renal disease patients who are initiating or undergoing
hemodialysis at dialysis centers in the United States. More
information about the trial is available at www.clinicaltrials.gov,
identifier NCT03934736.
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 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 to enhance the immune response.
Dynavax has worldwide commercial rights to HEPLISAV-B.
For more information about HEPLISAV-B,
visit: http://heplisavb.com/
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 fully-integrated
biopharmaceutical company focused on leveraging the power of the
body's innate and adaptive immune responses through toll-like
receptor (TLR) stimulation. Dynavax discovers, develops
and commercializes novel vaccines and immuno-oncology therapeutics.
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's lead
immunotherapy product, SD-101, is an investigational cancer
immunotherapeutic currently being evaluated in Phase 1/2 studies
and its second cancer immunotherapeutic, DV281, is in Phase 1
development. For more information, visit www.dynavax.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.
Contact
ir@dynavax.com
510-665-7269
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