- Clover’s protein-based COVID-19 vaccine candidates adjuvanted
with either GSK’s pandemic adjuvant system or Dynavax’s CpG 1018
plus alum induced strong neutralizing immune responses in 150 adult
and elderly subjects from the Phase 1 clinical study.
- Clover’s vaccine candidates both demonstrated a favorable
safety and tolerability profile, and have also shown long-term
stability at 2-8oC, making them suitable for global
distribution.
- A global phase 2/3 trial evaluating the safety and efficacy of
the S-Trimer vaccine candidate in combination with GSK’s pandemic
adjuvant system is expected to begin in December 2020 funded by the
Coalition for Epidemic Preparedness Innovations (CEPI).
- A separate pivotal Phase 2/3 clinical trial of the S-Trimer
vaccine candidate in combination with Dynavax’s advanced CpG 1018
adjuvant plus alum is intended to start in the first half of 2021
to maximize the potential supply of more than 1 billion doses of
Clover’s COVID-19 vaccines to the world.
Clover Biopharmaceuticals, a global clinical-stage biotechnology
company committed to developing transformative biologics as
vaccines and therapeutics for the world’s most debilitating
diseases, today announced positive clinical data from its Phase 1
trial demonstrating that its protein-based COVID-19 S-Trimer
vaccine candidates in combination with adjuvants from either GSK
(London Stock Exchange: GSK) or Dynavax (Nasdaq: DVAX) induces
strong immune responses, including neutralizing antibodies and
cell-mediated immunity, as well as favorable safety and
tolerability profiles in 150 adult and elderly participants. The
manuscript describing the detailed results will be accessible on an
online preprint server shortly.
The Phase 1 trial was a randomized, observer-blind,
placebo-controlled study to assess the safety, reactogenicity and
immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine
candidates formulated with different antigen levels. No serious
adverse events related to the vaccine candidates studied were
reported. The majority of adverse events were mild and transient.
S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced
neutralizing antibody titers (seroconversion) in 100% of
participants at the selected 9 µg S-Trimer dose in both adult and
elderly groups, with geometric mean titers (GMT) greater than
1:1,800. CpG-1018/alum-adjuvanted S-Trimer induced neutralizing
antibodies in 100% of adult participants at the selected 30 µg
S-Trimer dose with GMT greater than 1:1,000, and seroconversion was
observed in 88% (7 out of 8) in elderly. Strong Th1 cell-mediated
immune responses were also observed for the vaccine candidates with
either adjuvant.
Preliminary results from stability studies have demonstrated
that S-Trimer is stable at 2-8o C for at least six months
(longer-term stability studies are ongoing) and stable at room
temperature and 40o C for at least one month, in line with the
adjuvants tested. Thus, the ability of Clover’s COVID-19 vaccine
candidates to be stored in standard refrigeration temperatures
makes them suitable for broad global distribution based on current
results.
Based on the positive Phase 1 results reported and the
unprecedented need for COVID-19 vaccines, Clover and its partners
are confident to enter late-stage clinical development for both
adjuvanted vaccines. A global Phase 2/3 efficacy study of the
S-Trimer vaccine candidate in combination with GSK’s pandemic
adjuvant system is expected to begin in December 2020. Clover
intends to initiate a separate pivotal clinical trial of the
S-Trimer vaccine candidate in combination with Dynavax’s advanced
CpG 1018 adjuvant plus alum in the first half of 2021.
Joshua Liang, Chief Executive Officer of Clover
Biopharmaceuticals, said, “With positive results from our Phase 1
clinical trial demonstrating strong neutralizing immune responses
and favorable safety profiles, we look forward to moving our
COVID-19 vaccines into the final stages of clinical development.
Combined with our ability to potentially produce more than one
billion doses of antigen annually and the stability of our vaccines
under standard refrigeration conditions, our adjuvanted COVID-19
S-Trimer vaccines are positioned to be well-suited for worldwide
distribution. We and our collaborators are steadfast in our
commitment to the development of safe, effective and accessible
COVID-19 vaccines for the global population.”
Thomas Breuer, Chief Medical Officer of GSK Vaccines, commented,
“We are delighted by the promising Phase 1 clinical data
underscoring the robust and rapid immune response elicited by GSK’s
pandemic adjuvant system combined with Clover’s antigen - in both,
adults and older adults and are looking forward to demonstrate the
public health value in the upcoming efficacy trial. These results –
in addition to results from the combination of our adjuvant with
other COVID-19 vaccine technologies - show GSK’s commitment to
provide scalable solutions to tackle the pandemic around the
globe.”
Rob Janssen, Chief Medical Officer of Dynavax, commented, “We
are pleased with the strong immune responses and an outstanding
safety profile of Clover’s S-Trimer vaccine adjuvanted with
Dynavax’s advanced CpG 1018 adjuvant plus alum. We are encouraged
by the high level of neutralizing antibodies in combination with
the strong Th1 response which we believe could play an important
role in controlling infection. We are proud to be partnered with
Clover in our endeavors to develop a safe and effective COVID-19
vaccine that will be readily accessible around the world to combat
this ongoing pandemic.”
The Phase 1 clinical trial was funded by the Coalition for
Epidemic Preparedness Innovations (CEPI). “This is very promising
Phase 1 data which warrants further clinical development of
Clover’s S-Trimer vaccine candidate, “ Dr. Richard Hatchett, Chief
Executive Officer of CEPI commented, “This vaccine candidate has
the potential to be manufactured at scale and stored in a regular
refrigerator which makes it suitable for use around the globe,
including in low-resource settings. Through our partnership with
Clover we hope to make hundreds of millions of doses of this
vaccine globally accessible through COVAX, if it is proven to be
safe and effective.”
About COVID-19 S-Trimer Vaccine
Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer
is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine
candidate. Similar to other enveloped RNA viruses such as HIV, RSV
and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric
spike (S) protein on its viral envelope. The trimeric S protein of
SARS-CoV-2 is responsible for binding to host cell surface receptor
ACE2 and subsequent viral entry, making it the primary target
antigen for vaccine development. S-Trimer resembles the native
trimeric viral spike protein and is produced via a rapid mammalian
cell-culture based expression system. S-Trimer is intended to be
adjuvanted.
About Trimer-Tag© Technology
Trimer-Tag© is an innovative drug development platform which
allows the production of novel, covalently-trimerized fusion
proteins. Many major disease targets are trimerization-dependent
such as the tumor necrosis factor (TNF) superfamily (involved in
extrinsic apoptosis, immune co-stimulation and inflammation) as
well as enveloped RNA virus antigens responsible for entry into
host cells. Clover is using its Trimer-Tag© technology with global
IP position to develop recombinant trimerized fusion proteins that
are able to effectively target these previously undruggable
pathways.
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global, clinical-stage,
research-based biotechnology company focused on discovering,
developing and commercializing transformative biologic therapies,
with a focus on oncology and autoimmune diseases, as well as viral
vaccines. Having raised more than USD $350 million in total capital
since 2016, Clover is utilizing its proprietary Trimer-Tag©
technology platform to develop novel biologics targeting
trimerization-dependent pathways. Additionally, Clover is
leveraging its in-house GMP biomanufacturing capabilities to
support large-scale production of its biologic therapies. For more
information, please visit our website:
www.cloverbiopharma.com.
About GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. GSK is
the leading manufacturer of vaccines globally. For further
information please visit https://www.gsk.com/en-gb/about-us/
About Dynavax
Dynavax is a commercial stage biopharmaceutical company
developing and commercializing novel vaccines. The Company launched
its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine
(Recombinant), Adjuvanted], in February 2018, following U.S. FDA
approval for prevention of infection caused by all known subtypes
of hepatitis B virus in adults age 18 years and older. Dynavax is
also advancing CpG 1018 as an advanced vaccine adjuvant through
research collaborations and partnerships. For more information,
visit www.dynavax.com
About CEPI
CEPI is an innovative partnership between public, private,
philanthropic, and civil organizations, launched at Davos in 2017,
to develop vaccines to stop future epidemics. CEPI has moved with
great urgency and in coordination with WHO in response to the
emergence of COVID-19. CEPI has initiated nine partnerships to
develop vaccines against the novel coronavirus. The programs will
leverage rapid response platforms already supported by CEPI as well
as new partnerships.
Before the emergence of COVID-19 CEPI’s priority diseases
included Ebola virus, Lassa virus, Middle East Respiratory Syndrome
coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus.
CEPI also invested in platform technologies that can be used for
rapid vaccine and immunoprophylactic development against unknown
pathogens (Disease X).
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version on businesswire.com: https://www.businesswire.com/news/home/20201204005142/en/
Clover Biopharmaceuticals: Cindy Min Vice President,
Public Affairs cindy.min@cloverbiopharma.com +86 010-82022601
Media Contact: Alison Chen LifeSci Communications
achen@lifescicomms.com +1 646-876-4932
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