Clover’s COVID-19 Vaccine Candidate Demonstrates Superior Booster Responses Compared to Inactivated Vaccine
September 05 2022 - 7:17PM
Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global
clinical-stage biotechnology company developing novel vaccines and
biologic therapeutic candidates, today announced positive data from
its ongoing Phase 3 study evaluating Clover’s SCB-2019 (CpG
1018/Alum) as a universal COVID-19 booster vaccine candidate. The
preliminary data showed that SCB-2019 elicited superior levels of
neutralizing antibodies against the original strain of SARS-CoV-2
and Omicron subvariants BA.1 and BA.2 when administered as a
heterologous third dose in participants who previously received two
doses of an inactivated vaccine compared to a third dose of the
inactivated vaccine.
“The positive booster data against Omicron
subvariants from this landmark Phase 3 heterologous booster study
represents a pivotal step in our efforts to develop our lead
COVID-19 vaccine candidate as a universal booster,” said
Dr. Nicholas Jackson, President of Global R&D of
Clover. “These results further validate our confidence in
SCB-2019 as a valuable COVID-19 prevention option, especially in
China and other countries and regions where inactivated vaccines
have played an important role in primary vaccination
campaigns.”
A booster dose of SCB-2019 in participants who
previously received two doses of the inactivated vaccine elicited
superior neutralizing immune responses against the original strain
and Omicron BA.1 and BA.2 compared to responses in participants
receiving a third dose of the inactivated vaccine. Preliminary
analyses in subjects with low pre-booster neutralizing antibody
levels (defined as baseline pre-booster neutralizing antibody
titers ≤100 using validated live SARS-CoV-2 neutralization assays)
showed that SCB-2019 elicited a 17-fold increase in neutralizing
antibodies against the original strain, with geometric mean titers
(GMT) of antibodies increasing from 44 at baseline (pre-booster) to
733 (14 days post-booster). This response was 12-fold higher than
the response to the inactivated vaccine, which elicited a 2-fold
increase (GMTs: 33 [baseline], 61 [post-booster]) in neutralizing
antibodies against the original strain. In the same population,
SCB-2019 elicited a 6-fold increase (GMTs: 33 [baseline], 193
[post-booster]) in neutralizing antibodies against Omicron BA.1 and
an 8-fold increase (GMTs: 51 [baseline], 410 [post-booster]) in
neutralizing antibodies against Omicron BA.2. This response was 5
and 6-fold higher, respectively, than the response to the
inactivated vaccine, which elicited a 1-fold increase (GMTs: 30
[baseline], 42 [post-booster]) against Omicron BA.1 and a 1-fold
increase (GMTs: 47 [baseline], 67 [post-booster]) against Omicron
BA.2. Additional results against Omicron BA.5 in these participants
are expected in the near future.
These heterologous booster responses are
consistent with prior observations for SCB-2019 (CpG 1018/Alum) as
a homologous booster against Omicron BA.1 (LINK) and BA.2 (LINK)
and in subjects with prior infection against Omicron BA.5 (LINK)
and the original strain and all other Variants of Concern
(LINK).
These results are part of a Phase 3,
double-blind, randomized and controlled study that is evaluating
the safety and immunogenicity of SCB-2019 administered as a booster
dose in individuals who received two doses of inactivated vaccine
compared to third, homologous booster dose of the inactivated
vaccine. Clover is also currently enrolling a subcohort evaluating
SCB-2019 as a fourth dose booster in individuals previously
receiving three doses of the inactivated vaccine compared to a
fourth, homologous booster dose of the inactivated vaccine. The
study has enrolled over 1,500 adult and elderly participants in the
Philippines to date.
This new study data adds to the growing body of
evidence evaluating SCB-2019 as a potential universal COVID-19
booster candidate. Clover remains focused on completing regulatory
submissions to the China National Medical Products Administration,
the European Medicines Agency, and the World Health Organization
for SCB-2019 in the second half of 2022, while concurrently
preparing for its commercialization in China and globally.
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 Twitter
and 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, 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:Albert LiaoExecutive Director,
Corporate Communicationsmedia@cloverbiopharma.com
Naomi EichenbaumVP, Investor
Relationsinvestors@cloverbiopharma.com
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