Dynavax To Present Data From Pivotal Phase 3 HEPLISAV-B Trial
Data to Be Presented at NFID's Annual Conference on Vaccine Research, Monday April 18th in Baltimore
BERKELEY, CA -- (Marketwired) -- 04/04/16 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it will present HEPLISAV-B pivotal Phase 3 data at the National Foundation for Infectious Diseases' 19th Annual Conference on Vaccine Research (ACVR). The Conference will take place in Baltimore, Maryland from April 18th through April 20th. The Dynavax presentation is scheduled for Monday, April 18th at 3:45 p.m. EDT.
In late 2015, Dynavax completed its Phase 3 study of HEPLISAV-B (HBV-23) compared with Engerix-B® in adults 18-70 years of age. This study provided head-to-head safety and immunogenicity data compared with the current market leader in adult hepatitis B vaccines.
In January 2016, Dynavax reported top-line results demonstrating that both co-primary endpoints were met in this study. The rates of clinically significant adverse events were consistent with randomization and HEPLISAV-B provided a statistically significant higher rate of seroprotection than Engerix-B in diabetic participants and in all participants. The FDA has established September 15, 2016 as the Prescription Drug User Fee Act (PDUFA) action date for the HEPLISAV-B Biologics License Application.
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. In Phase 3 trials, HEPLISAV-B demonstrated higher and earlier protection with fewer doses than a currently licensed hepatitis B vaccine.
HEPLISAV-B is administered in two doses over one-month, offering rapid protection. Currently marketed hepatitis B vaccines are administered in three doses over a six-month schedule. Results of a published Vaccine Safety Datalink study showed that only 54 percent of adults completed the three-dose hepatitis B vaccine series in one year.1 Those who do not complete the series may not be adequately protected against hepatitis B.
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 diseases and oncology. Dynavax's lead product candidates are HEPLISAV-B™, a Phase 3 investigational adult hepatitis B vaccine, and SD-101, an investigational cancer immunotherapeutic currently in several Phase 1/2 studies. For more information, visit www.dynavax.com.
BERKELEY, CA -- (Marketwired) -- 04/04/16 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it will present HEPLISAV-B pivotal Phase 3 data at the National Foundation for Infectious Diseases' 19th Annual Conference on Vaccine Research (ACVR). The Conference will take place in Baltimore, Maryland from April 18th through April 20th. The Dynavax presentation is scheduled for Monday, April 18th at 3:45 p.m. EDT.
In late 2015, Dynavax completed its Phase 3 study of HEPLISAV-B (HBV-23) compared with Engerix-B® in adults 18-70 years of age. This study provided head-to-head safety and immunogenicity data compared with the current market leader in adult hepatitis B vaccines.
In January 2016, Dynavax reported top-line results demonstrating that both co-primary endpoints were met in this study. The rates of clinically significant adverse events were consistent with randomization and HEPLISAV-B provided a statistically significant higher rate of seroprotection than Engerix-B in diabetic participants and in all participants. The FDA has established September 15, 2016 as the Prescription Drug User Fee Act (PDUFA) action date for the HEPLISAV-B Biologics License Application.
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. In Phase 3 trials, HEPLISAV-B demonstrated higher and earlier protection with fewer doses than a currently licensed hepatitis B vaccine.
HEPLISAV-B is administered in two doses over one-month, offering rapid protection. Currently marketed hepatitis B vaccines are administered in three doses over a six-month schedule. Results of a published Vaccine Safety Datalink study showed that only 54 percent of adults completed the three-dose hepatitis B vaccine series in one year.1 Those who do not complete the series may not be adequately protected against hepatitis B.
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 diseases and oncology. Dynavax's lead product candidates are HEPLISAV-B™, a Phase 3 investigational adult hepatitis B vaccine, and SD-101, an investigational cancer immunotherapeutic currently in several Phase 1/2 studies. For more information, visit www.dynavax.com.