Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the
development of a new class of immunotherapeutic vaccines, announced
today that its next generation UB-612 COVID-19 vaccine, when
administered as a single heterologous booster dose, elicited strong
neutralizing antibodies against SARS-CoV-2 when compared
head-to-head to three globally authorized platform vaccines
administered as homologous boosters, confirming success in meeting
the primary and key secondary immunogenicity endpoints of its
pivotal global Phase 3 trial.
When delivered as a heterologous booster in three separate
substudies in populations previously vaccinated with
Pfizer-BioNTech’s BNT162b2, AstraZeneca’s ChAdOx1-S, or Sinopharm’s
BIBP, UB-612 was shown to generate neutralizing antibody titers 28
days after administration that were:
- Statistically
non-inferior* to, and directionally higher than, BNT162b2: 1.04 GMR
against Wuhan (95% CI: 0.89, 1.21; p=0.6147), 1.11 GMR against
Omicron BA.5 (95% CI: 0.94, 1.31; p=0.2171)
- Statistically
superior to ChAdOx1-S: 1.92-fold higher geometric mean titers
against Wuhan with UB-612 (GMR=1.92; CI: 1.44, 2.56; p<0.0001),
2.85-fold higher against Omicron BA.5 (GMR=2.85; CI: 2.00, 4.05;
p<0.0001)
- Statistically
superior to BIBP: 5.77-fold higher geometric mean titers against
Wuhan with UB-612 (GMR=5.77; CI: 4.62, 7.20; p<0.0001),
5.93-fold higher against Omicron BA.5 (GMR=5.93; CI: 4.60, 7.65;
p<0.0001)
“We have tested UB-612 head-to-head against three of the major
global market COVID-19 vaccine platforms, collectively administered
to over 3.5 billion people in over 180 countries, and achieved
superior or non-inferior results in each instance. Given these
Phase 3 topline results, and UB-612’s generally lower cost
structure and ease of distribution, we believe UB-612 has the
potential to serve as an optimal choice for boosting, especially in
developing countries, as COVID-19 enters an endemic stage,” said
Mei Mei Hu, CEO of Vaxxinity. “After multiple clinical trials, we
have consistently shown that UB-612 is well tolerated, continues to
elicit broad coverage against emerging variants, and generates a
durable neutralizing antibody titer. It’s the vaccine that I’d give
to my loved ones. These results also serve as further validation of
our technology and our ability to rapidly design and develop
vaccines to address major diseases on a global basis.”
Vaxxinity intends to complete rolling submissions with the
Medicines and Healthcare products Regulatory Agency (MHRA) in the
United Kingdom, and the Therapeutic Goods Administration (TGA) in
Australia, to support potential conditional and provisional
marketing authorizations, respectively, of UB-612 in the first half
of 2023. Vaxxinity expects that achieving authorizations in these
high income countries will open up the door to authorizations in
low and middle income countries and to the WHO’s Emergency Use
Listing (EUL), both of which align with Vaxxinity’s mission of
democratizing health across the globe.
Topline data from the Phase 3 trial also indicate that
seroconversion rates at day 29 (SCR, defined as ≥4-fold increase of
neutralizing antibody titers from baseline) of UB-612 were
statistically non-inferior** to and directionally higher than
BNT162b2, statistically superior to ChAdOx1-S, with 1.9-fold higher
SCR against Wuhan (23.6% absolute difference, p=0.0009) and
2.0-fold higher SCR against Omicron BA.5 (29.2% absolute
difference, p<0.0001), and statistically superior to BIBP, with
8.3-fold higher SCR against Wuhan (56.8% absolute difference,
p<0.0001) and 5.8-fold higher SCR against Omicron BA.5 (58.0%
absolute difference, p<0.0001).
Preliminary safety data show that UB-612 continues to be
generally well tolerated; no serious adverse events were reported.
The study is ongoing, and the long-term safety profile continues to
be evaluated.
The Phase 3 international, randomized, active-controlled
platform trial compares the safety and immunogenicity of a booster
dose of UB-612 in people who have received primary immunizations
with BNT162b2, ChAdOx1-S, or BIBP head-to-head against those of a
homologous boost. The trial recruited 944 participants aged 16
years and older across seven centers in the U.S., Panama, and
Philippines. The primary endpoints of the trial are safety,
tolerability, and live virus neutralizing antibody titers against
the Wuhan strain of SARS-CoV-2 at day 29. Secondary immunogenicity
endpoints include neutralizing antibody titers against Omicron at
day 29, seroconversion rates at day 29, and kinetics of
neutralizing and RBD binding IgG antibody responses through 12
months.
The Coalition for Epidemic Preparedness Innovations (CEPI) is
co-funding this trial, which will conclude in the second half of
2023, with additional long term follow up data on safety, T-cell
immunity, and durability of immune responses.
Dr. Melanie Saville, Executive Director of R&D at CEPI,
said, “COVID-19 is with us for the long term, so the world
continues to need a range of vaccine options to combat the virus
and its variants. We at CEPI are proud to support this clinical
trial to generate valuable evidence to inform booster strategies
for those previously vaccinated with shots distributed through
COVAX.”
The topline Phase 3 data support findings from Phases 1 and 2
that UB-612 elicits neutralizing antibodies against a broad array
of SARS-CoV-2 variants: data from Phases 1 and 2 suggest a UB-612
booster stimulated broadly reactive antibodies to the RBDs of 14
divergent variants including Alpha, Beta, Gamma, and Delta, and
were published in the Journal of Infectious Diseases. UB-612 is
formulated with an RBD protein, a key antigen target for
neutralizing antibodies, and peptide antigens which contain
epitopes that have remained highly conserved across variants.
UB-612-generated antibodies have a half-life of 6 months, longer
than the published half-lives of antibodies generated by mRNA,
adenovirus vector, and inactivated virus vaccines, suggesting that
immunity from UB-612 may last longer against emerging variants.
* GMR (geometric mean ratio) non-inferiority defined by lower
bound of 95% confidence interval > 0.67.**SCR non-inferiority
defined by lower bound of 95% confidence interval for UB-612 SCR –
comparator SCR difference > -10%.
About UB-612
UB-612 is the first multitope subunit protein/peptide-based
vaccine candidate for SARS-CoV-2, 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 >4,250 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. The pivotal Phase 3 trial of UB-612, co-funded
by the Coalition for Epidemic Preparedness Innovations (CEPI), is
designed to evaluate the ability of UB-612 to boost COVID-19
immunity in people immunized with one of three authorized COVID-19
vaccines. 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 “look forward,” “if,”
“plan,” “may,” “could,” “expect,” “potentially,” “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 a new class of
immunotherapeutic vaccines; the innovation, safety and potential
efficacy of Vaxxinity’s product candidates; and the anticipated
outcomes from the studies we are conducting or will conduct for our
product candidates.
Drug development and commercialization involve a high degree of
risk and only a small number of research and development programs
result in commercialization of a product. Results in early-stage
clinical trials may not be indicative of full results or results
from later stage or larger scale clinical trials and do not ensure
regulatory approval. You should not place undue reliance on these
statements, or the scientific data presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including without limitation, uncertainty of
success in the development and potential commercialization of
Vaxxinity’s product candidates; unexpected concerns may arise from
additional data, analysis or results of clinical studies of
Vaxxinity’s product candidates; regulatory authorities may require
additional information or further studies, or may fail or refuse to
approve or may delay approval of Vaxxinity’s drug candidates,
including UB-312, UB-313, VXX-401 and UB-612; the occurrence of
adverse safety events; the risks of other unexpected costs or
delays; failure to protect and enforce intellectual property and
other proprietary rights and uncertainties relating to intellectual
property claims and challenges; third party collaboration risks;
and the direct and indirect impacts of general economic, political,
demographic and business conditions. The foregoing does not list
all of the factors that could cause actual results to differ from
Vaxxinity’s expectations in any forward-looking statement.
Investors should consider this cautionary statement as well as the
risk factors identified in Vaxxinity’s most recent annual or
quarterly report and in other reports Vaxxinity has filed with the
U.S. 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 ContactJon Yumedia@vaxxinity.com
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