EMERYVILLE, Calif.,
Oct. 4, 2021 /PRNewswire/ -- Dynavax
Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical
company focused on developing and commercializing vaccines, and the
U.S. Department of Defense (DOD) today announced Dynavax has
executed an agreement for approximately $22
million over two and a half years to develop a recombinant
plague vaccine adjuvanted with CpG 1018®. Under
the agreement, Dynavax will conduct a Phase 2 clinical trial
combining its CpG 1018 adjuvant with the DOD's rF1V vaccine.
The Company anticipates the Phase 2 trial will commence in
2022.
Ryan Spencer, Dynavax's Chief
Executive Officer commented, "We are honored to receive this award
and to support the U.S. government in developing a plague vaccine
to protect the U.S. military members who put their lives at risk
every day in service to the country. 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. Our confidence in CpG 1018
is built on the successful development of our FDA-licensed 2-dose
adult hepatitis B vaccine and the multiple late-stage COVID-19
vaccine candidates utilizing CpG 1018."
This agreement, funded by the DOD's Joint Program Executive
Office for Chemical, Biological, Radiological and Nuclear Defense's
(JPEO-CBRND) Joint Project Manager for Chemical, Biological,
Radiological, and Nuclear Medical (JPM CBRN Medical), enables
Dynavax to conduct a Phase 2 clinical trial, submit an
Investigational New Drug (IND) application to the U.S. Food and
Drug Administration (FDA), and generate additional clinical trial
results to add to the existing clinical and non-clinical data. Any
future commercial supply agreements would be subject to a separate
agreement between Dynavax and the U.S government.
COL Ryan Eckmeier, the Joint
Project Manager for CBRN Medical commented, "Advancing the
development of a recombinant plague vaccine supports the JPM CBRN
Medical's vision to deliver a full, layered medical countermeasure
capability to enable a protected and unencumbered Joint Force to
fight and win in any global CBRN battlespace. Incorporating the CpG
1018 adjuvant to the DOD's rF1V vaccine will hopefully allow us to
protect our service members with fewer doses administered over a
shorter time period."
The planned Phase 2 randomized, placebo-controlled,
observer-blind, multicenter clinical trial will evaluate the
immunogenicity, safety, and tolerability of the rF1V vaccine
antigens provided by the U.S. government combined with Dynavax's
CpG 1018 adjuvant in adults 18 to 55 years of age.
About Plague*
Plague is a potentially
deadly infectious disease caused by bacteria found in fleas and
rodents or by handling an animal infected with plague. It is
caused by the bacterium, Yersinia pestis. It is
possible that Pneumonic plague bacteria could be released
intentionally in a biological attack to sicken people.
About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used
in HEPLISAV-B. Dynavax developed CpG 1018 adjuvant to provide an
increased vaccine immune response, which has been demonstrated in
HEPLISAV-B. CpG 1018 adjuvant provides a well- developed technology
and a significant safety database, potentially accelerating the
development and large-scale manufacturing of a COVID-19
vaccine.
About Dynavax
Dynavax is a commercial stage
biopharmaceutical company developing and commercializing novel
vaccines. The Company's first commercial product, HEPLISAV-B®
[Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the
U.S. and Europe for prevention of
infection caused by all known subtypes of hepatitis B virus in
adults age 18 years and older. Dynavax is also advancing CpG 1018
adjuvant as an advanced vaccine adjuvant through research
collaborations and partnerships. Current collaborations are focused
on adjuvanted vaccines for COVID-19, pertussis, universal influenza
and plague. For more information, visit www.dynavax.com and follow
the company on LinkedIn.
Forward-Looking Statements
This press release contains
"forward-looking statements," including statements regarding
expected results for an ongoing contractual relationship and
expected business results. 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 they may use
future dates. Forward-looking statements in this document include,
without limitation, statements regarding our expectations as to
outcomes relating to ongoing collaborations and contractual
relationships, the timing and potential outcomes of trials,
regulatory approvals and product launches. 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 or those
conducted by our other collaborators; whether and when any
vaccine candidate will be approved for use and launched; whether we
can manufacture sufficient quantities of CpG 1018 to support these
programs; 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, 2021. 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
narndt@dynavax.com
510-665-7264
Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
*CDC, https://www.cdc.gov/plague/index.html
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SOURCE Dynavax Technologies