Clover Announces Positive Phase 2/3 Results in Adolescents for its COVID-19 Vaccine
August 25 2022 - 6:23AM
Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global
clinical-stage biotechnology company developing novel vaccines and
biologic therapeutic candidates, today announced positive data from
a global Phase 2/3 trial evaluating Clover's COVID-19 vaccine
candidate, SCB-2019 (CpG 1018/Alum), in adolescents (aged 12 to 17
years). The study successfully met the primary endpoint and
demonstrated that vaccination with SCB-2019 (CpG 1018/Alum)
elicited approximately 2-fold higher neutralizing antibody titers
in adolescents compared to young adults (aged 18 to 25 years), a
population where SCB-2019 (CpG 1018/Alum) had previously been
demonstrated to be highly protective against COVID-19. Clover plans
to submit the data and seek licensure in adolescents from global
regulatory authorities, in addition to its ongoing submissions to
the China National Medical Products Administration (NMPA), the
European Medicines Agency (EMA), and the World Health Organization
(WHO) for use in adults and elderly, to broaden the potential use
of SCB-2019 (CpG 1018/Alum) across age groups and as a universal
COVID-19 booster vaccine.
“We are highly encouraged by these positive
pivotal Phase 2/3 trial data in adolescents. This new data shows
that SCB-2019 (CpG 1018/Alum) elicits a robust immune response
combined with a favorable safety and reactogenicity profile in
younger populations, where tolerability is critically important,”
said Dr. Nicholas
Jackson, President of Global Research and
Development of Clover. “These latest findings support our
COVID-19 vaccine candidate’s pathway to licensure across age groups
and its potential integral role in the long-term protection against
SARS-CoV-2 in China and globally."
The Phase 2/3 trial in adolescents enrolled
1,278 participants and evaluated the immunogenicity, safety, and
efficacy of SCB-2019 (CpG 1018/Alum) vaccine, administered as 2
doses given 21 days apart. The double-blind, randomized study met
the primary endpoint and demonstrated a superior, approximately
2-fold higher neutralizing immune response in adolescents (aged 12
to 17 years) compared to young adults (aged 18 to 25 years). In the
adult population (≥18 years of age), SCB-2019 (CpG 1018/Alum)
(LINK) had previously demonstrated 100% efficacy in preventing
severe COVID-19 and 95% efficacy against hospitalizations
associated with COVID-19 caused by any SARS-CoV-2 strain at 5
months after vaccination.
SCB-2019 (CpG 1018/Alum) demonstrated a
favorable safety and reactogenicity profile. Adverse events were
mostly mild and transient, were balanced between vaccine and
placebo (saline) groups, and comparable to results observed in the
adult population.
These study results will contribute to the
SCB-2019 (CpG 1018/Alum) data package and the licensure pathway for
Clover’s COVID-19 vaccine candidate in adolescents. Clover remains
focused on completing regulatory submissions to China NMPA, the
EMA, and the WHO for SCB-2019 (CpG 1018/Alum) in the second half of
2022, while concurrently preparing for its commercialization in
China and globally.
The development of SCB-2019 (CpG 1018/Alum) is
funded by the Coalition for Epidemic Preparedness Innovations
(CEPI), which has awarded Clover up to US$397.4 million in funding
to enable equitable access to Clover’s vaccine candidate.
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:
Cindy MinSVP, Public Affairsmedia@cloverbiopharma.com
Naomi EichenbaumVP, Investor
Relationsinvestors@cloverbiopharma.com
Dynavax Technologies (NASDAQ:DVAX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Dynavax Technologies (NASDAQ:DVAX)
Historical Stock Chart
From Sep 2023 to Sep 2024