Dynavax Technologies Corporation
) received encouraging news when the design of its next
large-scale clinical study on its hepatitis B vaccine candidate,
Heplisav, was finalized following discussions with the U.S. Food
and Drug Administration (FDA).
We remind investors that Dynavax suffered a setback in Jun
2013 when the FDA asked for additional safety data on Heplisav.
The company had conducted a meeting with the agency to discuss
the complete response letter (CRL) received earlier this year for
the Heplisav Biologic License Application (BLA).
The FDA had then stated that the database needed additional
subjects as analyzing the safety profile on the current database
would probably lead to an approval for a limited population
thereby preventing additional patients to benefit from the
treatment if approved. The collection of data on a broader
population will facilitate review of the indication in adults in
the age bracket of 18-70.
Hence, the phase III study, HBV-23 study (n=8,000), is planned
to provide a sufficiently-sized safety database for the FDA to
complete its review of Dynavax's BLA.
The phase III study will evaluate the overall safety and
immunogenicity of Heplisav as compared to
) Engerix-B in adults in the age group of 18 to 70 years. The
study is also expected to generate additional immunogenicity data
on Heplisav in patients suffering from diabetes. Dynavax plans to
initiate HBV-23 study in the first quarter of 2014 and complete
enrolment by 2015 end.
The external cost of the study is estimated in the range of
Meanwhile, Dynavax has also submitted Heplisav for review in
Europe. Dynavax is currently preparing its response to the
European Medicines Agency's (EMA) 120-Day List of Questions which
is required to be submitted in the fourth quarter of 2013.
Thereafter, Dynavax expects a response to the same from the EMA
in the first quarter of 2014.
We note that Dynavax currently does not have any approved
product in its portfolio. We expect investor focus to remain on
Heplisav updates in the near term.
Dynavax carries a Zacks Rank #4 (Sell). Right now,
) look well placed. Both carry a Zacks Rank #1 (Strong Buy).
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