Data on Dynavax' Heplisav - Analyst Blog


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Dynavax Technologies Corporation ( DVAX ) announced that immunogenicity and safety data from two phase III trials (HBV-16 and HBV-17) on its hepatitis B vaccine candidate, Heplisav, were published in the journal VACCINE .

One of the trials assessed the immunogenicity and safety of Heplisav compared to a licensed hepatitis B vaccine in healthy adults in the age group of 40-70.

The trial was conducted in the U.S. and Canada among 2,400 subjects. The results from the trial showed that Heplisav induced significantly higher seroprotection rates in all groups (including hyporesponsive populations) versus the licensed hepatitis B vaccine in a shorter two-dose schedule over one month.

The other trial assessed the immunogenicity and safety of Heplisav compared to a licensed hepatitis B vaccine in patients suffering from chronic kidney disease (CKD). This trial was conducted in the U.S. and Germany among 500 patients suffering from CKD. The results showed that three doses of Heplisav provided significantly higher and persistent seroprotection rates as compared to the licensed hepatitis B vaccine.

The safety profile of Heplisav was maintained in both the trials.

We note that Dynavax currently does not have any approved product in its portfolio.

Dynavax suffered a setback in Jun 2013 when the U.S. Food and Drug Administration (FDA) asked for additional safety data in response to a meeting with the agency to discuss the complete response letter (CRL) received earlier in 2013 on Heplisav. We expect investor focus to remain on Heplisav updates.

Apart from lead candidate Heplisav, Dynavax is also developing AZD1419 (asthma) in partnership with AstraZeneca ( AZN ) and DV1179 (autoimmune and inflammatory diseases) with GlaxoSmithKline ( GSK ).

Dynavax carries a Zacks Rank #3 (Hold). Right now, Actelion Ltd . ( ALIOF ) looks attractive with a Zacks Rank #1 (Strong Buy).


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