Vaxxinity Initiates Rolling Submission for UB-612 COVID-19 Vaccine with MHRA (UK)
September 12 2022 - 8:00AM
Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the
development of a new class of immunotherapeutic vaccines, today
announced that it has initiated a rolling submission to the
Medicines and Healthcare products Regulatory Agency (MHRA) in the
United Kingdom for conditional marketing authorization of its
UB-612 COVID-19 vaccine as a heterologous boost to authorized
primary series vaccines. UB-612 is currently being assessed in a
Phase 3 pivotal trial as a booster vaccine for subjects who have
received primary immunization with mRNA, adenovirus vector, or
inactivated virus vaccines. Vaxxinity reiterates its plan to have a
topline readout of the Phase 3 trial in the fourth quarter of 2022.
“Authorizations by stringent regulatory authorities such as the
MHRA could open the pathway for UB-612 to reach countries with high
unmet needs,” said Mei Mei Hu, CEO of Vaxxinity. “Because so many
low and middle income (LMIC) countries look to stringent
regulators' decisions as a reference, we anticipate that MHRA
authorization, if achieved, could ultimately enable Vaxxinity to
market UB-612 in a number of LMIC countries across the globe, which
is the heart of Vaxxinity’s mission. Additionally, this
authorization is a pathway to grant WHO emergency use listing
(EUL), which would provide another option for getting UB-612 to
countries through the COVAX program.”
About UB-612
UB-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 directed against
multiple structural viral antigens. 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 humoral and T-cell
immunity, and a strong booster memory recall inducing high levels
of neutralizing antibodies against Delta, Omicron, and other
SARS-CoV-2 variants. UB-612 is now in a pivotal Phase 3 trial. More
details on the trial can be found at clinicaltrials.gov using
Identifier NCT05293665.
About Vaxxinity
Vaxxinity, 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.
For more information about Vaxxinity, Inc., visit
http://www.vaxxinity.com and follow us on social media
@vaxxinity.
Forward-looking Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. The use of certain words, including “could,” “anticipate,”
“would,” "potentially," and "will" and similar expressions, are
intended to identify forward-looking statements. These
forward-looking statements involve substantial risks and
uncertainties, and are based on the current expectations and
assumptions of Vaxxinity’s management. Forward-looking statements
include statements about the development of immunotherapeutic
vaccines 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 and other reports we file
with the Securities and Exchange Commission. 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.
Investor ContactBenjamin
Matonebenm@vaxxinity.com
Press ContactKaren Chasemedia@vaxxinity.com
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