SAINT-HERBLAIN, France and
EMERYVILLE, Calif., Sept. 14, 2020 /PRNewswire/ -- Valneva
SE ("Valneva"), a specialty vaccine company focused on
prevention of diseases with major unmet needs, and Dynavax
Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical
company focused on developing and commercializing novel vaccines,
today announced a commercial partnership for the supply of
Dynavax's CpG 1018 adjuvant for use in Valneva's SARS-CoV-2 vaccine
candidate, VLA2001. Valneva separately announced today an
agreement with the UK government to provide up to 190 million doses
of VLA20011 over a five year period. Dynavax will supply
CpG 1018 to produce up to 100 million doses of vaccine in 2021.
Valneva has the option to purchase up to an additional 90 million
doses through 2025.
Thomas Lingelbach, Chief
Executive Officer of Valneva, commented, "We are pleased
to partner with Dynavax on the further development and
future commercialization of our COVID-19 vaccine. We believe
that CpG 1018 will add significant value to the target
product profile of our vaccine including its intended use in at
risk populations. This agreement marks another step in our approach
to find a safe and effective solution to address the virus that is
continuing to have an impact on us all."
Ryan Spencer, Chief Executive
Officer of Dynavax, commented, "Dynavax is proud to be
working with Valneva to support development and commercialization
of an adjuvanted vaccine candidate to prevent COVID-19. We are
pleased to extend our current partnership to include commercial
supply of CpG 1018, our advanced adjuvant. We believe CpG 1018 may
play a critical role in the development of a safe and effective
vaccine, including potentially enhancing the immune response for
those who are traditionally less responsive to vaccination and are
at greatest risk for severe disease from COVID-19."
Valneva expects VLA2001 to enter clinical studies by the end of
2020 and to potentially reach regulatory approval in the second
half of 2021.
This commercial supply partnership follows Valneva and Dynavax's
initial collaboration to advance COVID-19 vaccine development,
announced in April
20202.
About VLA2001
VLA2001 is a Vero-cell based, highly
purified inactivated vaccine candidate against the SARS-CoV-2
virus, leveraging the manufacturing technology for Valneva's
Japanese encephalitis vaccine. The Company has designed a process
that largely uses this platform in regards to upstream- and
downstream process steps as plug-and-play with moderate
adjustments. The process includes inactivation with BPL to preserve
the native structure of the S protein. The combination with CpG
1018 is expected to induce a strong immune response and has the
potential to generate high titers of neutralizing antibodies as
well as a polarized Th1 response. VLA2001 is expected to conform
with standard cold chain requirements (2 degrees to 8 degrees
centigrade).
About Valneva SE
Valneva is a specialty vaccine
company focused on prevention against diseases with major unmet
needs. Valneva's portfolio includes two commercial vaccines for
travelers: IXIARO®/JESPECT® indicated for the
prevention of Japanese encephalitis and DUKORAL®
indicated for the prevention of cholera and, in some countries,
prevention of diarrhea caused by ETEC. The Company has various
vaccines in development including unique vaccines against Lyme
disease, chikungunya and SARS-CoV-2. Valneva has operations in
Austria, Sweden, the United
Kingdom, France,
Canada and the US with over 500
employees. For more information, visit the Company website at
www.valneva.com and follow Valneva on LinkedIn.
About Vaccine Adjuvants
An adjuvant is a
pharmacological or immunological agent that modifies the effect of
other agents. Adjuvants are added to a vaccine to boost the immune
response to produce more antibodies and longer-lasting immunity,
thus minimizing the dose of antigen needed. Adjuvants may also be
used to enhance the efficacy of a vaccine by helping to modify the
immune response by particular types of immune system cells.
About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used
in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an
adult hepatitis B vaccine approved by the U.S. Food and Drug
Administration (FDA). Dynavax developed CpG 1018 to provide an
increased vaccine immune response, which has been demonstrated in
HEPLISAV-B. CpG 1018 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 launched its first commercial product,
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted], in February 2018,
following U.S. FDA approval for prevention of infection caused by
all known subtypes of hepatitis B virus in adults age 18 years and
older. Dynavax is also further developing CpG 1018 as an advanced
vaccine adjuvant through research collaborations and partnerships.
Current collaborations are focused on adjuvanted vaccines for
COVID-19, pertussis and universal influenza. For more information,
visit www.dynavax.com and follow the company on LinkedIn.
Dynavax Forward-Looking Statements
This press release
contains "forward-looking" statements, including statements
regarding the potential development of a COVID-19 vaccine
containing CpG 1018 and the commercial sale of CpG 1018 to be used
in the vaccine. Actual results may differ materially from
those set forth in this press release due to the risks and
uncertainties inherent in vaccine research and development,
including the timing of completing development, the results of
clinical trials, whether CpG 1018 will provide an enhanced immune
response, whether and when the vaccine containing CpG 1018
will be approved for use, whether and when purchases of CpG 1018
will occur, and the ability to manufacture sufficient supply to
meet the purchasing needs, as well as other risks detailed in
the "Risk Factors" section of our Annual Report on Form 10-K for
the fiscal year ended December 31,
2019 as well as discussions of potential risks,
uncertainties and other important factors in our other filings with
the U.S. Securities and Exchange Commission. We undertake no
obligation to revise or update information herein to reflect events
or circumstances in the future, even if new information becomes
available. Information on Dynavax's website at www.dynavax.com is
not incorporated by reference in our current periodic reports with
the SEC.
Valneva Forward-Looking Statements
This press release
contains certain forward-looking statements relating to the
business of Valneva, including with respect to the progress, timing
and completion of research, development and clinical trials for
product candidates, the ability to manufacture, market,
commercialize and achieve market acceptance for product candidates,
the ability to protect intellectual property and operate the
business without infringing on the intellectual property rights of
others, estimates for future performance and estimates regarding
anticipated operating losses, future revenues, capital requirements
and needs for additional financing. In addition, even if the actual
results or development of Valneva are consistent with the
forward-looking statements contained in this press release, those
results or developments of Valneva may not be indicative of their
in the future. In some cases, you can identify forward-looking
statements by words such as "could," "should," "may," "expects,"
"anticipates," "believes," "intends," "estimates," "aims,"
"targets," or similar words. These forward-looking statements are
based largely on the current expectations of Valneva as of the date
of this press release and are subject to a number of known and
unknown risks and uncertainties and other factors that may cause
actual results, performance or achievements to be materially
different from any future results, performance or achievement
expressed or implied by these forward-looking statements. In
particular, the expectations of Valneva could be affected by, among
other things, uncertainties involved in the development and
manufacture of vaccines, unexpected clinical trial results,
unexpected regulatory actions or delays, competition in general,
currency fluctuations, the impact of the global and European credit
crisis, and the ability to obtain or maintain patent or other
proprietary intellectual property protection. In light of these
risks and uncertainties, there can be no assurance that the
forward-looking statements made during this presentation will in
fact be realized. Valneva is providing the information in these
materials as of this press release, and disclaim any intention or
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise.
Valneva Investor
and Media Contacts
Laetitia
Bachelot-Fontaine
Director of Investor
Relations & Corporate Communications
M +33 (0)6 4516
7099
investors@valneva.com
|
Teresa
Pinzolits
Corporate
Communications Specialist
T +43 (0)1 20620
1116
communications@valneva.com
|
Dynavax Contacts
Nicole
Arndt, Senior Manager, Investor Relations
narndt@dynavax.com
510-665-7264
Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
1 Valneva Confirms Participation in UK
Government COVID-19 Vaccine Response Program
2 Valneva and Dynavax Announce Collaboration to
Advance Vaccine Development for COVID-19
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SOURCE Dynavax Technologies