Clover Doses First Participants in Phase 3 Trial Evaluating SCB-2019 as a Heterologous COVID-19 Booster Following Prior Vaccination with Inactivated, mRNA or Viral Vector Vaccines
June 13 2022 - 8:11PM
Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global
clinical-stage biotechnology company developing novel vaccines and
biologic therapeutic candidates, today announced the first
participants have been dosed in a Phase 3 study evaluating the
safety and immunogenicity of Clover’s SCB-2019 (CpG 1018/Alum)
vaccine candidate as a COVID-19 booster in individuals who
previously vaccinated with CoronaVac™ (Sinovac Inactivated
Vaccine), Comirnaty® (Pfizer mRNA Vaccine), or Vaxzevria®
(AstraZeneca Viral Vector Vaccine).
“Building on the strength of our promising
booster results to-date demonstrating that SCB-2019 (CpG 1018/Alum)
can significantly boost broad neutralization against Omicron and
other variants, we are delighted to initiate this Phase 3 study to
advance the development of SCB-2019 as a potential universal
COVID-19 booster candidate,” said
Dr. Nicholas Jackson,
Ph.D., President of Global Research and
Development of Clover. “As Omicron and new subvariants
continue to challenge existing vaccine immunity necessitating
booster vaccines that can elicit potent and broad protection, we
believe that SCB-2019 could play an important role in supporting
the increased demand for a universal COVID-19 booster vaccine.”
The Phase 3 trial is a double-blind, randomized,
controlled study that will evaluate the safety and immunogenicity
of SCB-2019 (CpG 1018/Alum) administered as a booster dose in
individuals who received two doses of CoronaVac™, Comirnaty®, or
Vaxzevria®. Individuals receiving a homologous booster dose of
CoronaVac™, Comirnaty®, or Vaxzevria®, will be used as controls
compared to the heterologous SCB-2019 (CpG 1018/Alum) booster dose.
Initial data for the key third dose booster groups (CoronaVac™,
Comirnaty®) are expected in Q3-2022, and third dose booster data in
the Vaxzevria® group is expected in Q4-2022. Clover also plans to
initiate a subcohort evaluating SCB-2019 (CpG 1018/Alum) as a
fourth dose booster in individuals previously receiving three doses
of CoronaVac™ with initial results expected in Q4-2022. The
study will enroll over 1,200 adult & elderly participants in
the Philippines.
This new study will add to the growing body of
evidence evaluating SCB-2019 (CpG 1018/Alum) as a potential
universal COVID-19 booster candidate. Data from another study
announced in April 2022 showed that a heterologous booster dose of
SCB-2019 (CpG 1018/Alum) administered in individuals previously
receiving two doses of AstraZeneca’s COVID-19 vaccine elicited a
more rapid response and higher levels of neutralizing antibodies
against the prototype virus and variants of concern (including
Omicron) compared to individuals receiving three doses of
AstraZeneca’s COVID-19 vaccine. The company plans to include these
universal COVID-19 booster data in its regulatory submissions when
available.
About SCB-2019 (CpG
1018/Alum)Employing the Trimer-Tag™ technology platform,
Clover developed the SCB-2019 antigen, a stabilized trimeric form
of the S-protein (referred to as S-Trimer™) based on the original
strain of the SARS-CoV-2 virus. Clover created its COVID-19 vaccine
candidate by combining SCB-2019 with Dynavax’s (Nasdaq: DVAX) CpG
1018 advanced adjuvant and aluminum hydroxide (alum).
About Clover BiopharmaceuticalsClover
Biopharmaceuticals is a global clinical-stage biotechnology company
committed to developing novel vaccines and biologic therapeutic
candidates. The Trimer-Tag™ technology platform is a product
development platform for the creation of novel vaccines and
biologic therapies. Clover leveraged the Trimer-Tag™ technology
platform to become a COVID-19 vaccine developer and created
SCB-2019 (CpG 1018/Alum) to address the COVID-19 pandemic caused by
SARS-CoV-2.
For more information, please visit Clover’s
website: www.cloverbiopharma.com and follow the company
on LinkedIn.
Clover Forward-looking StatementsThis 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
participant 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. Participant 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.
Clover Biopharmaceuticals:
Cindy MinSVP, Public Affairsmedia@cloverbiopharma.com
Naomi EichenbaumVP, Investor
Relationsinvestors@cloverbiopharma.com
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