The pipeline continues to progress well at
Dynavax Technologies Corporation
) after it suffered a setback in Jun 2013.
We remind investors that 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 its hepatitis B vaccine candidate, Heplisav.
Nevertheless, last month, Dynavax announced that
immunogenicity and safety data from two phase III trials (HBV-16
and HBV-17) on Heplisav were published in the journal
. The data from both the trials were encouraging.
Meanwhile, Dynavax is working on developing other candidates
in its pipeline. Dynavax recently initiated dosing for the first
trial on candidate AZD1419 in a phase I study.
We note that Dynavax is developing AZD1419, a toll-like
receptor (TLR) agonist, for the treatment of asthma in
The study will initially assess the safety of AZD1419 as
compared to placebo on healthy subjects in single and multiple
Thereafter, the second part of the study will enrol 24
patients suffering from mild asthma. Dynavax expects safety data
from the first study of the trial by mid-2014.
Apart from lead candidate Heplisav and AZD1419, Dynavax is
developing DV1179 (autoimmune and inflammatory diseases) with
We note that Dynavax currently does not have any approved
product in its portfolio. Hence, we expect investor focus to
remain on further pipeline updates.
Dynavax carries a Zacks Rank #4 (Sell). Right now,
) looks attractive with a Zacks Rank #1 (Strong Buy).
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