EMERYVILLE, Calif., Sept. 12,
2022 /PRNewswire/ -- Dynavax Technologies Corporation
(Nasdaq: DVAX), a commercial-stage biopharmaceutical company
developing and commercializing innovative vaccines, in
collaboration with the U.S. Department of Defense's (DOD) Joint
Program Executive Office for Chemical, Biological, Radiological and
Nuclear Defense (JPEO-CBRND) and supported by the DOD's
Chemical and Biological Defense Program, today announced that the
first participant has been dosed in a Phase 2 clinical trial
evaluating the immunogenicity, safety, and tolerability of the
JPEO-CBRND's Recombinant Plague (rF1V) vaccine combined with
Dynavax's CpG 1018®adjuvant, in adults 18 to 55 years of
age.
"We are proud to support the U.S. government in developing an
effective adjuvanted plague vaccine that we believe will allow U.S.
service members to be protected with fewer doses administered over
a shorter period of time," commented Ryan
Spencer, Chief Executive Officer of Dynavax. "The
development of a CpG 1018 adjuvanted plague vaccine is an important
example of the broad utility of our adjuvant which we are
leveraging to build our pipeline of new and improved vaccines."
As previously announced, Dynavax and the DOD executed an
agreement which provides for approximately $22 million in funding over two and a half years
to develop an improved recombinant plague vaccine adjuvanted with
CpG 1018 adjuvant. Under the agreement, Dynavax will conduct
a Phase 2 clinical trial combining its CpG 1018 adjuvant with the
DOD's rF1V vaccine. The trial is assessing a two-dose regimen
administered over one month. Previous clinical studies of the rF1V,
not including CpG 1018 adjuvant, have evaluated a three-dose
regimen over six months. Any future commercial supply agreements
would be subject to a separate agreement between Dynavax and the
U.S government.
About CpG 1018 Adjuvant
Dynavax developed CpG 1018 adjuvant to provide an increased
vaccine immune response with an improved tolerability profile,
which has been demonstrated in HEPLISAV-B vaccine for adult
hepatitis B and multiple COVID-19 vaccines that have received
Emergency Use Authorization outside of the U.S. CpG 1018 adjuvant
provides a well-developed technology and a significant safety
database, potentially accelerating the development and large-scale
manufacturing of novel or improved vaccines.
About Dynavax
Dynavax is a commercial-stage biopharmaceutical company
developing and commercializing innovative vaccines to help protect
the world against infectious diseases. The Company has two
commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine
(Recombinant), Adjuvanted], which is approved in the U.S. and the
European Union for the prevention of infection caused by all known
subtypes of hepatitis B virus in adults 18 years of age and older,
and CpG 1018® adjuvant, currently used in multiple adjuvanted
COVID-19 vaccines. Dynavax is advancing CpG 1018 adjuvant as a
premier vaccine adjuvant through global research collaborations and
partnerships. Current collaborations are focused on adjuvanted
vaccines for COVID-19, seasonal influenza, universal influenza,
plague, shingles and Tdap. For more information about our marketed
products and development pipeline, visit www.dynavax.com and follow
Dynavax on LinkedIn.
Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, which are subject to a number of risks and uncertainties.
All statements that are not historical facts are forward-looking
statements. Forward-looking statements can generally be identified
by the use of words such as "anticipate," "believe," "continue,"
"could," "estimate," "expect," "forecast," "intend," "will," "may,"
"plan," "project," "potential," "seek," "should," "think," "will,"
"would" and similar expressions, or the negatives thereof, or they
may use future dates. Forward-looking statements in this document
include, without limitation, statements regarding our expectations
as to outcomes relating to ongoing contractual relationships, the
timing and potential outcomes of trials. These forward-looking
statements are subject to assumptions, risks and uncertainties that
may change at any time, and readers are therefore cautioned that
actual results could differ materially from those expressed in any
forward-looking statements. Factors that could cause actual results
to differ include, among other things: risks and uncertainties
associated with actual results of our clinical trials; whether and
when an improved plague vaccine candidate will be approved for use
and launched; whether we can manufacture sufficient quantities of
CpG 1018 to support this program; and other risks and uncertainties
discussed in the Company's filings with the SEC, including the
"Risk Factors" sections of the Company's Quarterly Report on Form
10-Q for the quarter ended June 30,
2022. The Company undertakes no obligation to update any
forward-looking statements as a result of new information, future
developments or otherwise, except as expressly required by law. All
forward-looking statements in this document are qualified in their
entirety by this cautionary statement.
Contacts:
Nicole Arndt,
Investor Relations and Corporate Communications
narndt@dynavax.com
510-665-7264
Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
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SOURCE Dynavax Technologies