- Clover to procure CpG 1018 adjuvant from Dynavax for use in the
commercial production of Clover's COVID-19 vaccine candidate,
SCB-2019 (CpG 1018/Alum)
- Pending conditional regulatory approvals, Clover expects to
commence product launch of SCB-2019 (CpG 1018/Alum) by the end of
2021
CHENGDU, China and EMERYVILLE, Calif., June 30, 2021
/PRNewswire/ -- Clover Biopharmaceuticals (Clover), a global
clinical-stage biotechnology company developing novel vaccines and
biologic therapeutic candidates to address the world's most
life-threatening diseases and public health threats, and Dynavax
Technologies Corporation (Dynavax, Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines, today announced the execution of a commercial
supply agreement of Dynavax's CpG 1018TM advanced
adjuvant, for use in Clover's protein-based COVID-19 vaccine
candidate, SCB-2019 (CpG 1018/Alum).
The commercial supply agreement extends to the end of 2022.
The agreement includes doses for delivery in 2021, which
were manufactured under the previously announced funding agreement
between Coalition for Epidemic Preparedness Innovations (CEPI)
and Dynavax.
Clover separately announced today an advanced purchase agreement
with Gavi, the Vaccine Alliance, for supplying up to 414 million
doses of SCB-2019 (CpG 1018/Alum) through 2022 for the COVAX
Facility. The COVAX Facility is a global risk-sharing mechanism for
pooled procurement and equitable distribution of COVID-19 vaccines,
regardless of income level. Pending conditional regulatory
approvals, Clover expects to commence product launch of SCB-2019
(CpG 1018/Alum) by the end of 2021, supplying the COVAX Facility
and countries directly via government procurement and/or bilateral
supply agreements.
"Throughout the development of our COVID-19 vaccine candidate,
Dynavax has been an invaluable partner with a shared goal of
maximizing our collective impacts in fighting the unprecedented
COVID-19 pandemic. We look forward to the continued partnership as
we accelerate large-scale production of SCB-2019 (CpG 1018/Alum)
for potential commercial supply to communities in need around the
globe," stated Joshua Liang, Chief
Executive Officer of Clover Biopharmaceuticals.
Ryan Spencer, Chief Executive
Officer of Dynavax commented, "Dynavax is excited for the
opportunity to expand our partnership with Clover into an important
commercial supply agreement to provide significant amounts of CpG
1018 for combatting the ongoing pandemic. We are proud to support
the ongoing development and the potential near-term
commercialization of SCB-2019 (CpG 1018/Alum)."
About SCB-2019 (CpG 1018/Alum)
SCB-2019 (CpG 1018/Alum), Clover's COVID-19 vaccine candidate,
is anticipated to be one of the first commercialized protein-based
COVID-19 vaccines globally through the COVAX Facility. Employing
the Trimer-Tag© technology platform, Clover developed
the SCB-2019 antigen, a stabilized trimeric form of the S-protein
(S-Trimer) based on the original strain of the SARS-CoV-2 virus.
Clover's COVID-19 vaccine candidate is the combination of SCB-2019
and two adjuvants, Dynavax's CpG 1018 advanced adjuvant and
aluminum hydroxide (alum).
Clover is currently advancing SPECTRA, a global pivotal Phase
2/3 clinical trial evaluating the efficacy, safety, and
immunogenicity of SCB-2019 (CpG 1018/Alum), and expects interim
data for vaccine efficacy around the middle of 2021. Pending
positive interim data, Clover plans to submit conditional
regulatory approval applications to the EMA, the NMPA and the WHO
in the second half of 2021, and plans to commence product launch by
the end of 2021.
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global clinical-stage
biotechnology company committed to developing novel vaccines
and biologic therapeutic candidates to address the world's most
life-threatening diseases and public health threats. The
Trimer-Tag© technology platform is a product development
platform for the creation of novel vaccines and
biologic therapies. We have leveraged the
Trimer-Tag© technology platform to become a
COVID-19 vaccine developer and potentially one of the first
companies to commercialize a protein-based COVID-19 vaccine
globally through the COVAX Facility. For more information, please
visit our website: www.cloverbiopharma.com and follow
the company on LinkedIn.
Clover Forward-looking Statements
This press release contains certain forward-looking statements
and information relating to us and our subsidiaries that are based
on the beliefs of our management as well as assumptions made by and
information currently available to our management. When used in
this [document], the words "aim," "anticipate," "believe," "could,"
"estimate," "expect," "going forward," "intend," "may," "might,"
"ought to," "plan," "potential," "predict," "project," "seek,"
"should," "will," "would" and the negative of these words and other
similar expressions, as they relate to us or our management, are
intended to identify forward-looking statements.
Forward-looking statements are based on our current expectations
and assumptions regarding our business, the economy and other
future conditions. We give no assurance that these expectations and
assumptions will prove to have been correct. Because
forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks and changes in circumstances that
are difficult to predict. Our results may differ materially from
those contemplated by the forward-looking statements. They are
neither statements of historical fact nor guarantees or assurances
of future performance. We caution you therefore against placing
undue reliance on any of these forward-looking statements. Any
forward-looking statement made by us in this document speaks only
as of the date on which it is made. Factors or events that could
cause our actual results to differ may emerge from time to time,
and it is not possible for us to predict all of them. Subject to
the requirements of applicable laws, rules and regulations, we
undertake no obligation to update any forward-looking statement,
whether as a result of new information, future events or otherwise.
All forward-looking statements contained in this document are
qualified by reference to this cautionary statement.
About CpG 1018
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)
and the European Commission. 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'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 as a premier
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 to develop a COVID-19
vaccine containing CpG 1018, the timing and amount of potential
sales to Clover and the timing of regulatory approvals. 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 initiating
clinical trials and completing development, whether CpG 1018 plus
aluminum combined with Clover's protein subunit vaccine will prove
to be beneficial in clinical trials, whether and when the vaccine
will be approved for use, whether CEPI will continue to fund the
Clover program through development and licensure, whether or how
much Gavi or other commercial customers purchase from Clover, and
whether sufficient quantities of CpG 1018 will be able to be
manufactured, 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, 2020, 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.
Clover Biopharmaceuticals:
Cindy Min
Vice President, Public Affairs
media@cloverbiopharma.com
Naomi Eichenbaum
Vice President, Investor Relations
investors@cloverbiopharma.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
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SOURCE Clover Biopharmaceuticals