Dynavax and Clover Biopharmaceuticals Announce Research Collaboration to Evaluate Coronavirus (COVID-19) Vaccine Candidate wi...
March 24 2020 - 8:30AM
Dynavax Technologies Corporation (Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines, and Clover Biopharmaceuticals, a China-based global
clinical-stage biotechnology company focused on developing novel
and transformative biologic therapies, today announced that they
have entered into a research collaboration to develop a vaccine
candidate to prevent COVID-19. Clover is advancing evaluation
of its protein-based coronavirus vaccine candidate (COVID-19
S-Trimer) in preclinical studies. Dynavax is providing
technical expertise and the company’s proprietary toll-like
receptor 9 (TLR9) agonist adjuvant, CpG 1018, to support this
initiative.
In late-January 2020, upon knowing the genomic
DNA sequence of the newly identified SARS-CoV-2 virus, which causes
a disease named COVID-19, Clover scientists started designing the
viral spike (S)-protein construct and completed its gene synthesis.
Utilizing its patented Trimer-Tag© technology, Clover has produced
a COVID-19 S-Trimer subunit vaccine candidate that resembles the
native trimeric viral spike via a rapid mammalian cell-culture
based expression system. Having one of the largest in-house,
commercial-scale cGMP biomanufacturing capabilities in China,
Clover could potentially rapidly scale-up and produce
large-quantities of a new coronavirus vaccine.
“At Clover, we are eager to begin evaluating the
combination of our S-Trimer vaccine candidate and Dynavax’s CpG
1018 adjuvant, as we believe adjuvants could play an important role
in developing a successful and widely-available vaccine for this
pandemic,” said Joshua Liang, Chief Strategy Officer at Clover and
co-inventor of COVID-19 S-Trimer vaccine. “Leveraging our
proprietary© Trimer-Tag technology, S-Trimer is being rapidly
developed to support global efforts in combating the current and
any future coronavirus outbreaks.”
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.
“Successfully responding to this public health
emergency will require a collaborative approach, combining
technologies and sharing data, to rapidly develop a vaccine to
prevent COVID-19,” commented Ryan Spencer, Chief Executive Officer
of Dynavax. “We are proud to contribute to this global effort with
the goal of supporting rapid development and enabling large-scale
manufacturing through the utilization of CpG 1018 which has already
been successfully implemented in an approved, marketed vaccine in
the U.S.”
About the Novel Coronavirus SARS-CoV-2
(and COVID-19 Disease)SARS-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 334,000 people and has caused over 14,600
reported deaths (as of 23 March 2020). It has been declared a
pandemic by the World Health Organization (WHO). Currently
there is no vaccine available for COVID-19.
About COVID-19 S-Trimer
VaccineUtilizing Trimer-Tag© technology, S-Trimer is a
trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.
Similar to other enveloped RNA viruses such as HIV, RSV and
Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric
spike (S) protein on its viral envelope. The trimeric S protein of
SARS-CoV-2 is responsible for binding to host cell surface receptor
ACE2 and subsequent viral entry, making it the primary target
antigen for vaccine development. S-Trimer resembles the native
trimeric viral spike protein and is produced via a rapid mammalian
cell-culture based expression system.
About Clover
BiopharmaceuticalsChina based Clover Biopharmaceuticals is
a global, clinical-stage, research-based biotechnology company
focused on discovering, developing and commercializing
transformative biologic therapies, with a focus on oncology and
autoimmune diseases, as well as viral vaccines. Having raised more
than US$ 100 million in total capital since 2016, Clover is
utilizing its proprietary Trimer-Tag© technology platform to
develop novel biologics targeting trimerization-dependent pathways.
Additionally, Clover is leveraging its in-house cGMP
biomanufacturing capabilities to develop select biosimilars. For
more information, please visit our website:
www.cloverbiopharma.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.
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.
Contact - Clover
Biopharmaceuticals Joshua Liang, +86 028-63925705
joshua.liang@cloverbiopharma.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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