Clover’s COVID-19 Vaccine Candidate Demonstrates Strong Cross-Neutralization Against Omicron as a Homologous Booster
27 Junho 2022 - 07:04AM
Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global
clinical-stage biotechnology company developing novel vaccines and
biologic therapeutic candidates, today announced new positive
clinical data in individuals vaccinated with a third dose of
SCB-2019 (CpG 1018/Alum) as a homologous booster against the
Omicron variant. A homologous booster dose of SCB-2019 (CpG
1018/Alum) demonstrated a significant, 19-fold increase in
neutralizing antibody levels against the Omicron BA.2 variant
compared to pre-booster levels among baseline seronegative
participants.
“This highly encouraging homologous booster data against Omicron
represents a key milestone on Clover’s path to developing SCB-2019
for primary vaccination and as a universal COVID-19 booster vaccine
to protect individuals in need, regardless of previous vaccination
technology or infection history,” said Joshua Liang, Chief
Executive Officer and Executive Director of
Clover. “With the ongoing surges of COVID-19 cases
driven by Omicron, there is an urgent need for boosting with safe
and effective COVID-19 vaccines in China and globally, and we
believe the data demonstrate that SCB-2019 is a premium COVID-19
vaccine candidate.”
In this study, a homologous booster dose of SCB-2019 (CpG
1018/Alum) in individuals who previously received two doses of
SCB-2019 (CpG 1018/Alum) induced a robust and rapid neutralizing
antibody immune response in this preliminary analysis. A cohort
comprised of individuals who were baseline seronegative
(individuals with no evidence of natural infection using anti-N
antibody testing and observed waning neutralizing antibody levels
after the second dose and prior to the booster dose) demonstrated a
robust 19-fold increase against the Omicron BA.2 variant and a
12-fold increase in neutralizing antibodies against the Omicron
BA.1 variant compared to pre-booster levels.
“Combining these promising data with the positive heterologous
booster data in individuals previously vaccinated with a viral
vector COVID-19 vaccine or in previously infected individuals,
further strengthens our confidence that our lead COVID-19 vaccine
can play a pivotal role in broadly boosting protection against
Omicron and other variants of concern, with a favorable safety and
tolerability profile,” said Dr. Nicholas Jackson, President
of Global Research and Development of Clover. “As part of
our universal booster development for SCB-2019, we look forward to
sharing additional clinical data, including top line head-to-head
data comparing SCB-2019 as a heterologous, 3rd booster dose against
homologous 3rd booster doses of CoronaVac™ and Comirnaty® in Q3
2022.”
This double-blind, randomized, controlled study
evaluated the immunogenicity and safety of SCB-2019 (CpG 1018/Alum)
as a homologous booster dose administered approximately six months
following a two-dose primary vaccination with SCB-2019 (CpG
1018/Alum). In total, 3,755 participants were recruited in Brazil,
the Philippines and Columbia. Clover will further evaluate study
participants for immunogenicity, durability, and safety, and
intends to make data available in a manuscript for peer-review
publication when available.
Clover remains focused on completing regulatory
submissions to the China NMPA, the EMA, and the WHO for SCB-2019
(CpG 1018/Alum) in the second half of 2022, while concurrently
preparing for global commercialization.
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 Biopharmaceuticals
Clover 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
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forward-looking statements relate to the future, they are
participant to inherent uncertainties, risks and changes in
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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
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rules and regulations, we undertake no obligation to update any
forward-looking statement, whether as a result of new information,
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contained in this document are qualified by reference to this
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Clover
Biopharmaceuticals:
Cindy MinSVP, Public
Affairsmedia@cloverbiopharma.com
Naomi EichenbaumVP,
Investor Relationsinvestors@cloverbiopharma.com
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