- Valneva is leveraging its technical and platform capabilities
to develop an inactivated, whole virus vaccine candidate against
the current coronavirus threat
- Dynavax is providing CpG 1018, the adjuvant contained in U.S.
FDA-approved HEPLISAV-B vaccine, to support the development of
Valneva´s COVID-19 vaccine candidate
- Valneva will seek grant funding to support the required
investment for this program
Saint-Herblain (France), Emeryville (U.S.),
April 22, 2020 – Valneva SE, a specialty vaccine company focused on
prevention against diseases with major unmet needs, and Dynavax
Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical
company focused on developing and commercializing novel vaccines,
today announced their collaboration to initiate a vaccine program
for the current coronavirus, COVID-19.
Valneva´s scientific team has tirelessly
explored opportunities to rapidly leverage Valneva´s existing
technology, capabilities and infrastructure to create a SARS-CoV-2
vaccine candidate in response to the current pandemic.
Valneva is leveraging its well-established
platform for IXIARO®, the Company’s commercial vaccine product
indicated for active immunization for the prevention of Japanese
encephalitis. This platform operates on a highly purified Vero-cell
based, inactivated, whole virus strategy for vaccine
development.
Dynavax is providing technical expertise and the
company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant,
CpG 1018, 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.
Valneva will use its Biosafety Level 3
laboratory capabilities to rapidly leverage its large scale,
Vero-based, viral Good Manufacturing Practice manufacturing
facility in Livingston, Scotland, where both IXIARO® and VLA1553,
the Company’s vaccine candidate against chikungunya, are currently
manufactured.
Wolfgang Bender, Ph.D., M.D., Chief
Medical Officer of Valneva, commented: “Valneva aims to
contribute to a world in which no one dies or suffers from a
vaccine-preventable disease, such as COVID-19. Although different
vaccine technologies are being deployed in the global effort to
combat COVID-19, we believe that a proven approach is the best
option for rapidly delivering a safe and effective vaccine. The
proven approach that we are taking to develop VLA2001 has the
potential to yield protection for the general population, as well
as high risk groups, including the elderly, immuno-compromised and
individuals suffering from other diseases.”
Ryan Spencer, Chief
Executive Officer of Dynavax commented: “Now more than
ever, the world is feeling the crucial role vaccines play in
protecting our families, communities, and those at high risk for
infectious disease. Dynavax’s mission is to investigate, innovate,
and improve vaccines to provide protection for an unpredictable
world. We are pleased to partner with Valneva on this important
development effort to address the global health crisis spawned by
COVID-19.”
Professor George Siber, MD, Member of
Valneva´s Scientific Advisory Board commented: “Although
many companies are advancing novel vaccine approaches to develop a
vaccine against SARS-COV-2, the Scientific Advisory Board strongly
supports this approach. There is a high likelihood that a modern,
inactivated SARS-CoV-2 vaccine combined with an adjuvant such as
CpG 1018 could be effective and safe.”
Valneva and Dynavax will work with regulatory
authorities to align on the optimal strategy to execute an
expedited clinical development path, with the goal to initiate
clinical trials before the end of 2020.
About the Novel Coronavirus SARS-CoV-2
and COVID-19 DiseaseSARS-CoV-2 is a new coronavirus
identified in late 2019 and belongs to a family of enveloped RNA
viruses that include MERS and SARS, both of which caused serious
human infections of respiratory system. The virus, which causes a
disease named COVID-19, has never before been found in humans.
Since this outbreak was first reported in late-2019, the virus has
infected over 2.5 million people and has caused over 170,000
reported deaths (as of April 22, 2020). It has been declared a
pandemic by the World Health Organization (WHO). Currently, there
is no vaccine available for COVID-19.
About VLA 2001VLA2001 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.
About Valneva SEValneva 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 and
chikungunya. Valneva has operations in Austria, Sweden, the United
Kingdom, France, Canada and the US with over 500 employees. More
information is available at www.valneva.com.
About DynavaxDynavax 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 advancing
CpG 1018 as an advanced vaccine adjuvant through research
collaborations and partnerships. For more information, visit
www.dynavax.com and follow the company on LinkedIn.
Dynavax Forward-Looking
StatementsThis press release contains "forward-looking"
statements, including statements regarding the potential to develop
a COVID-19 vaccine and to do so on an accelerated basis.
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, and whether
and when the vaccine will be approved for use, 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 ContactsLaetitia
Bachelot-FontaineDirector of Investor Relations & Corporate
CommunicationsM +33 (0)6 4516 7099investors@valneva.com |
Teresa
PinzolitsCorporate Communications SpecialistT +43 (0)1 20620
1116communications@valneva.com |
Contacts - DynavaxNicole Arndt, Senior Manager,
Investor Relationsnarndt@dynavax.com510-665-7264
Derek Cole, President Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
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