Blog Coverage Dynavax Releases New Data Showing That its Vaccine HEPLISAV-B Offers Higher Seroprotection Against Hepatitis B

LONDON, UK / ACCESSWIRE / October 27, 2016 / Active Wall St. blog coverage looks at the headline from Dynavax Technologies Corp. (NASDAQ: DVAX). The company announced on October 26, 2016, the results of the pivotal Phase 3 trial of the sub group HBV-23 for its investigational hepatitis B vaccine HEPLISAV-B. The data were presented at the Infectious Diseases Society of America’s (IDSA) annual IDWeek 2016 at New Orleans. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

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The results of the analysis of the sub group HBV-23 confirmed that HEPLISAV-B, stimulated significantly higher seroprotection rates with fewer doses than the currently licensed hepatitis B vaccine Engerix-B®. The analysis compared the results of treatment of patients with hepatitis B using HEPLISAV-B when provided as two doses over the course of a month as compared to Engerix-B, which was administered as three doses over six months.

Commenting on the development, Rob Janssen, M.D., Chief Medical Officer for Dynavax said:

“We were encouraged to see that HEPLISAV-B administered as two doses over one month provided a significantly higher rate of seroprotection in these individuals than the existing hepatitis B vaccine. The lower immunogenicity observed in sub-groups in the Engerix-B arm of this Phase 3 study demonstrates the critical need for a hepatitis B vaccine that can provide higher rates of seroprotection with fewer doses to adequately protect adults against the consequences of this chronic viral infection.”

Results of Phase 3 trial of the sub group HBV-23 (Poster #754)

The total participants for treatment under this group were 8,374 in the age group of 18 – 70 years. The study compared the results of patients who were given two doses of HEPLISAV-B over four weeks with the three doses of Engerix-B over 24 weeks. The sub group was divided in terms of age, sex, BMI, type of diabetes, and smoking status. Overall study results showed a significantly higher seroprotection rate with HEPLISAV-B versus Engerix-B (95.4% at week 24 versus 81.3% at week 28, respectively). The majority difference was identified in participants who were older, had diabetes, high BMI (body mass index), or who smoked.

In patients with diabetes, HEPLISAV-B offered seroprotection in 90% of the participants, whereas Engerix-B offered only 24.9% seroprotection.

In patients with BMI of 30 or more HEPLISAV-B offered seroprotection rate of 94.7% whereas for Engerix-B it was 75.4%.

In patients in the age group of 60 -70 years HEPLISAV-B offered seroprotection at 91.6% whereas for Engerix-B it was 72.6%.

In patients who were smokers HEPLISAV-B offered seroprotection at 95.9% whereas for Engerix-B it was 78.6%.

The adverse effects common to both was the site pain of the injection whereas other adverse effects recorded were fatigue, headache, and malaise.

About HEPLISAV-B

HEPLISAV-B is an investigational adult hepatitis B injectable vaccine which is administered in two doses over one month. The vaccine combines hepatitis B surface antigen with a proprietary Toll-like receptor 9 agonists to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B. HEPLISAV-B and its Biologics License Application is currently under US Food and Drug Administration (FDA) review. The FDA has established a Prescription Drug User Fee Act (PDUFA) action date of December 15, 2016.

Dynavax had announced in September 2016 that the FDA’s Biologics Evaluation and Research cancelled the scheduled Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. The meeting was scheduled for November 16, 2016, to review the Biologics License Application (BLA) for HEPLISAV-B.

About Engerix-B

ENGERIX-B is an injectable vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus. It is manufactured by GlaxoSmithKline Biologicals.

What is Hepatitis B?

Hepatitis B is a virus that infects the liver and can go undetected as the symptoms are like that of the common flu. In extreme cases, it can lead to cirrhosis of the liver, hepatocellular carcinoma, and death. The US Centres for Disease Control and Prevention (CDC) stated that around 20,000 people are infected with it annually and currently does not have a cure or any method of disease prevention.

Stock Performance

The new data release helped the stock of Dynavax to jump in the early trading; however at the closing bell, on Wednesday, October 26, 2016, Dynavax Technologies’ stock slightly slipped 0.99% from its previous closing price of $10.15, ending the trading session at $10.05. A total volume of 940.79 thousand shares were traded at the end of the day. The stock currently has a market cap of $398.08 million.

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