The Coalition for Epidemic Preparedness Innovations (CEPI) and
Vaxxinity, Inc. (Nasdaq: VAXX), a US company pioneering the
development of a new class of immunotherapeutic vaccines, today
announced that they will co-fund the ongoing global pivotal Phase 3
clinical trial of Vaxxinity’s next generation UB-612 COVID-19
vaccine candidate as a heterologous – or ‘mix-and-match’ – booster
dose. CEPI will provide up to $9.25m in funding.
The Phase 3 trial, which began in the US earlier this year, is
evaluating the ability of UB-612 to boost COVID-19 immunity against
the original strain and multiple variants of concern including
Omicron - in people aged 16 years or older, who have been
previously immunized with an authorized COVID-19 vaccine. Prior to
joining the trial, participants will have received a primary
regimen of one of the vaccines developed by Oxford- AstraZeneca,
Pfizer-BioNTech, Sinopharm, or Sinovac, all of which are being
distributed by COVAX, which primarily supplies to low- and
middle-income countries (LMICs). Participants are being assessed
for safety and immunogenicity after a single booster dose of
UB-612, or a homologous booster (i.e., a booster dose of the same
vaccine the participant has received before), enabling comparisons
between UB-612 and other regimens. Details on the Phase 3
UB-612-305 clinical trial can be found at clinicaltrials.gov using
Identifier NCT05293665.
Approximately 1,000 healthy adults will take part in the
Vaxxinity-sponsored multi-center international trial, with the
first subjects already dosed in the US. The primary immunogenicity
analyses will be available in the second half of 2022. If
successful, this trial may enable global authorizations, including
in high income countries and LMICs.
Data on mix-and-match combinations of vaccines – like those
being assessed in this trial - will contribute to the design of
flexible vaccination strategies aimed at controlling COVID-19 and
combatting emerging SARS-CoV-2 variants. UB-612 can be manufactured
at scale and data generated so far support storage conditions that
potentially make it especially suitable for use in LMICs. In line
with CEPI’s Equitable Access Policy, all data from the clinical
trial will be shared through open-access publications and via
scientific meetings to ensure that all can benefit from the
research, and that the data can be used to inform the
recommendations of policy makers and regulatory authorities on the
use of COVID-19 vaccines.
Dr Richard Hatchett, CEO of CEPI, said:
“As we strive to stay one step ahead of COVID-19, mix-and-match
boosters could play an important role in protecting people against
new variants by improving the strength and breadth of immune
responses. This CEPI-supported trial will generate additional
evidence to inform booster strategies in people previously
vaccinated with vaccines distributed through COVAX, including
against variants of concern.”
Mei Mei Hu, Co-Founder and CEO of Vaxxinity,
said:
“We greatly appreciate the support from CEPI at this critical
time in the pandemic. As we reach majority vaccination levels in
high income countries, we must remember that LMICs lag far behind.
With our mission to democratize health, we strive to deliver
transformational science-led innovation that is not only safe,
well-tolerated and accessible to all but is intended to be
variant-ready and may protect against new SARS-CoV-2 variants.”
Expanding access to COVID-19 vaccines by filling R&D
gaps
This is the latest programme to be funded in response to a CEPI
Call for Proposals launched in January 2021 which aims to address
current gaps in our clinical knowledge of vaccine performance both
now and in the long term, in order to expand access to COVID-19
vaccines as part of the global vaccination rollout. Examples of
such gaps include assessment of the safety and effectiveness of
COVID-19 vaccines in pregnant women, infants and children, and
immunocompromised populations, as well as studies on booster doses,
length of vaccine efficacy, mix-and-match strategies, and dosing
intervals. In response to this Call for Proposals, CEPI is also
funding a study of COVID-19 vaccines in immunosuppressed and
transplant patients, a project to expand access to BBIBP-CorV in
Africa, a clinical trial of mix-and-match combinations of vaccines
in Pakistan, and a mix-and-match booster study in Taipei. In
addition, CEPI has previously announced funding to support a
mix-and-match study led by the University of Oxford, and is
supporting trials to evaluate fractional COVID-19 booster shots in
multiple countries.
This work forms part of CEPI’s next 5-year plan, published in
March 2021, which aims to reduce or even eliminate the future risk
of pandemics and epidemics. As part of this plan CEPI is working to
strengthen our defences against COVID-19 and reduce the risk of
future coronavirus pandemics, by optimizing our current vaccines,
addressing variants of concern, developing next-generation COVID-19
vaccines, and initiating the development of broadly protective or
universal coronavirus vaccines.
About CEPICEPI is an innovative
partnership between public, private, philanthropic, and civil
organizations, launched at Davos in 2017, to develop vaccines
against future epidemics. Prior to COVID-19 CEPI’s work focused on
developing vaccines against Ebola virus, Lassa virus, Middle East
Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever
virus and Chikungunya virus – it has over 20 vaccine candidates
against these pathogens in development. CEPI has also invested in
new platform technologies for rapid vaccine development against
unknown pathogens (Disease X).
During the current pandemic, CEPI initiated multiple programmes
to develop vaccines against SARS-CoV-2 and its variants with a
focus on speed, scale and access. These programmes leverage the
rapid response platforms developed by CEPI’s partners prior to the
emergence of COVID-19 as well as new collaborations. The aim is to
advance clinical development of a diverse portfolio of safe and
effective COVID-19 vaccine candidates and to enable fair allocation
to these vaccines worldwide through COVAX.
CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress
vaccine development timelines to 100 days, develop a universal
vaccine against COVID-19 and other Betacoronaviruses, and
create a “library” of vaccine candidates for use against known and
unknown pathogens. The plan is available
at: https://endpandemics.cepi.net/.
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About UB-612UB-612 is the first multitope
subunit protein/peptide-based vaccine candidate for SARS-CoV-2,
which is designed to activate both B and T-cell arms of the immune
system. Phase 1 and Phase 2 trials of UB-612 conducted in ~4000
participants have shown UB-612 to be well tolerated with no
vaccine-related serious adverse events. The most striking findings
were induction of long-lasting virus neutralizing antibodies, broad
T-cell immunity against SARS-CoV-2 variants and a strong booster
memory recall inducing high levels of neutralizing antibodies
against Delta, Omicron and other variants. UB-612 is now in a
pivotal Phase 3 trial.
About VaxxinityVaxxinity, Inc. is a
purpose-driven biotechnology company committed to democratizing
healthcare across the globe. The company is pioneering a new class
of synthetic, peptide-based immunotherapeutic vaccines aimed at
disrupting the existing treatment paradigm for chronic disease,
increasingly dominated by monoclonal antibodies, which suffer from
prohibitive costs and cumbersome administration. The company’s
proprietary technology platform has enabled the innovation of novel
pipeline candidates designed to bring the efficiency of vaccines to
the treatment of chronic diseases, including Alzheimer’s,
Parkinson’s, migraine, and hypercholesterolemia. The technology is
also implemented as part of a COVID-19 vaccine program. Vaxxinity
has optimized its pipeline to achieve a potentially historic,
global impact on human health.
Forward-looking StatementThis press release
includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. The use of
certain words, including "believe," "may," “continue,” “advancing,”
“aim,” “strive,” “intend,” "will" and similar expressions, are
intended to identify forward-looking statements. These
forward-looking statements involve substantial risks and
uncertainties, including statements that are based on the current
expectations and assumptions of Vaxxinity’s management about the
development of a new class of immunotherapeutic vaccines, the
potential outcome and findings of Phase 3 trials for UB-612 and the
innovation and efficacy of Vaxxinity’s product candidates. Various
important factors could cause actual results or events to differ
materially from those that may be expressed or implied by our
forward-looking statements. Additional important factors to be
considered in connection with forward-looking statements are
described in the "Risk Factors" section of the Company's Annual
Report on Form 10-K filed with the Securities and Exchange
Commission on March 24, 2022. The forward-looking statements are
made as of this date and Vaxxinity does not undertake any
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
required by law.
CEPI Media ContactsEmail: press@cepi.netPhone: +44 7387
055214Vaxxinity Media Contacts:Investor ContactClaudia
Styslingervaxxinity@argotpartners.com
Press ContactPhilip Cowdellmedia@vaxxinity.com
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