Clover’s Bivalent COVID-19 Vaccine Candidate Demonstrates Broad Neutralization Against Omicron and Other Variants of Concern
05 Maio 2022 - 08:00AM
Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global
clinical-stage biotechnology company developing novel vaccines and
biologic therapeutic candidates, today announced new promising data
from a preclinical study on Clover’s bivalent vaccine candidate,
which combines the trimeric spike antigens from the original
SARS-CoV-2 strain and the Omicron variant. The bivalent vaccine
candidate elicited broad neutralization against all Variants of
Concern (VoC), including Omicron, in both primary vaccination and
booster settings in a preclinical study. The manuscript
“
Cross-Protection to VOCs by Bivalent S-Trimer COVID19
Vaccine” is available for pre-print on bioRxiv and will be
submitted for peer-review publication in a scientific journal.
“Given the SARS-CoV-2 virus is expected to continue changing,
development of a broadly protective COVID-19 vaccine that can
potently neutralize existing and potential future variants is
critical to preparing for the next chapter of COVID-19. We are
excited by the emerging data demonstrating broad neutralization for
our new bivalent COVID-19 vaccine candidate, and we believe the
breadth observed is a result of combining spike proteins from two
strains at diverse ends of the mutation universe, namely the
original strain and the Omicron variant,” said
Dr. Nicholas Jackson, President of Global Research and
Development of Clover. “Importantly, our bivalent
candidate also utilizes the same Trimer-Tag™ platform as our
prototype COVID-19 vaccine, SCB-2019 (CpG 1018/Alum), which has
previously demonstrated a favorable safety profile and significant
field efficacy against COVID-19 in a global Phase 2/3 trial. Thus,
we believe there is a potential licensure pathway for the bivalent
candidate based on clinical immuno-bridging to SCB-2019 (CpG
1018/Alum). We look forward to continued development of this
exciting new candidate and providing a new tool for the world in
this ongoing fight against COVID-19.”
In the pre-clinical study, the bivalent COVID-19 vaccine
candidate was comprised of the trimeric spike proteins from the
original strain (SCB-2019) and the Omicron variant (SCB-2022B). In
mice immunized in both the primary vaccination setting and the
booster setting (previously vaccinated with two doses of prototype
vaccine), the bivalent COVID-19 vaccine candidate demonstrated
potent neutralization of all VoCs including the Omicron variant.
Importantly, compared to the monovalent Omicron variant vaccine
(SCB-2022B) alone, the bivalent COVID-19 vaccine demonstrated
higher levels of neutralization against most of the variants tested
and comparable levels against Omicron.
Based on these findings, Clover intends to advance development
of the bivalent COVID-19 vaccine candidate into clinical
development. Clover also expects to initiate a Phase 1 trial in the
second quarter of this year evaluating SCB-2020S (a prototype and
beta-variant chimeric vaccine candidate) to demonstrate
proof-of-concept for variant strain change utilizing the
Trimer-Tag™ platform. Clover remains focused on completing
regulatory submissions to the NMPA, the EMA, and the WHO for
SCB-2019 (CpG 1018/Alum) as well as preparing for commercialization
in China and around the world as the highest priorities, given that
the clinical results to-date suggest that SCB-2019 (CpG 1018/Alum)
as a booster vaccine can significantly increase immune responses
against Omicron.
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 Bivalent Candidate Employing the
Trimer-Tag™ technology platform, Clover has developed a bivalent
vaccine candidate based upon the prototype vaccine candidate
SCB-2019 (CpG 1018/Alum) and SCB-2022B antigen, a stabilized
trimeric form of the S-protein (referred to as S-Trimer™) based on
the Omicron strain of the SARS-CoV-2 virus. Clover has developed
the Bivalent candidate by combining SCB-2019, SCB-2020B, and
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 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, 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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