Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced positive results from a preclinical study
of AdCOVID in a SARS-CoV-2 challenge model of infection. In this
study, a single intranasal dose of AdCOVID provided sterilizing
immunity in the lungs of vaccinated mice, in contrast to the
development of dense pulmonary infection and disease in the lungs
of non-vaccinated mice following infection with SARS-CoV-2. AdCOVID
is a novel, single-dose intranasal vaccine candidate for COVID-19.
“These latest data are very exciting, as they
confirm and expand upon the numerous potential advantages of our
differentiated intranasal vaccine approach,” said Scot Roberts,
Ph.D., Chief Scientific Officer at Altimmune. “In the current
study, we found a heavy burden of infectious SARS-CoV-2 virus in
the lungs of non-vaccinated mice following challenge with the
virus. Importantly, no detectable levels of infectious virus were
observed in the lungs of AdCOVID-vaccinated animals.”
Dr. Roberts continued, “These data suggest that
a single intranasal vaccination with AdCOVID may provide
sterilizing immunity that neutralizes infectious virus, which is
believed to be the best way to block viral transmission. Blocking
transmission is critical for preventing spread of the virus and
preventing the emergence of new variants of concern, both of which
have the potential to prolong the pandemic. We continue to be
encouraged by the accumulating preclinical data for AdCOVID and
look forward to reporting the results of our ongoing Phase 1
clinical trial later this quarter.”
“Growing vaccine hesitancy, which is emerging as
a real problem in the fight against SARS-CoV-2, underscores the
importance of developing novel vaccine approaches like AdCOVID,
which is a needle-free, thermostable vaccine that may be delivered
in a single-dose and has the potential to prevent SARS-CoV-2
transmission. These attributes could foster vaccine acceptance,
both nationally and globally. In addition, intranasally delivered
AdCOVID could play a critical role in re-vaccination campaigns to
control future spread of the virus, and ultimately to help bring an
end to this devastating global pandemic,” said collaborator Frances
Lund, Ph.D., Charles H. McCauley Professor and Chair for the
Department of Microbiology at the University of Alabama at
Birmingham (UAB).
In the current study, performed in collaboration
with UAB, K18-hACE2 transgenic mice, which are highly permissive
for SARS-CoV-2 replication and considered one of the best models
for COVID-19, were vaccinated with a single intranasal dose of
AdCOVID and challenged one month later with live SARS-CoV-2
virus.
When the lungs of the mice were evaluated for
infectious SARS-CoV-2 virus, no detectable levels of infectious
virus were observed in the lungs of vaccinated mice, representing a
greater than one million-fold reduction of infectious virus
compared to the non-vaccinated controls. This demonstration of
sterilizing immunity is consistent with the stimulation of local
and systemic immunity by AdCOVID shown in previous animal studies,
including high serum neutralizing antibody and T cell responses,
and most importantly, mucosal IgA responses in the respiratory
tract.
In previously reported preclinical studies,
AdCOVID was associated with a 29-fold induction of spike-specific
IgA and resident memory T cell responses in the lungs of
experimental animals, as well as robust systemic serum neutralizing
antibody titers and T cell responses in the lung and spleen.
The ongoing AdCOVID Phase 1 clinical trial is
evaluating the safety and immunogenicity of AdCOVID following a
single dose or two intranasal doses administered one month apart
and is expected to report topline data in June 2021. The trial is
evaluating three different dose levels of AdCOVID and will measure
local mucosal IgA responses in the nasaopharyngeal cavity, systemic
serum immune responses, including serum neutralizing antibody
relative to COVID-19 convalescent serum, and T cell responses
directed against the spike protein receptor binding domain.
About AdCOVID
AdCOVID is a single-dose intranasal vaccine
candidate for COVID-19. It is designed to stimulate a broad immune
response including both systemic immunity (neutralizing antibody)
and local immunity (mucosal IgA, resident memory T cells) in the
nasal cavity and respiratory tract.
In published preclinical studies
(www.biorxiv.org/content/10.1101/2020.10.10.331348v1) conducted in
collaboration with the University of Alabama at Birmingham, potent
serum neutralizing antibody responses, T cell responses, and a
robust induction in mucosal immunity were observed in mice
following a single intranasal dose of AdCOVID. Mucosal immunity was
characterized by IgA antibody and resident memory T cell responses
in the respiratory tract, both of which are believed to be
important in fighting infection, and importantly, transmission. In
other preclinical studies, AdCOVID provided 100% protection against
lethal SARS-CoV-2 challenge.
Based on data from Altimmune’s other intranasal
platform vaccine candidates, AdCOVID is expected to have extended
stability at room temperature that would allow for cold chain-free
shipment of the vaccine. If demonstrated, AdCOVID could be stored
in the common refrigerators found in community-based doctors’
offices and pharmacies for two years or more. The Company believes
that these simple and convenient handling requirements, together
with the potential ability to block SARS-CoV-2 transmission, could
position AdCOVID as a leading intranasal COVID-19 vaccine.
About Altimmune
Altimmune is a clinical stage biopharmaceutical
company focused on developing intranasal vaccines, immune
modulating therapies and treatments for liver disease. Our diverse
pipeline includes proprietary intranasal vaccines for COVID-19
(AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an
intranasal immune modulating therapeutic for COVID-19 (T-COVID™);
and next generation peptide therapeutics for NASH (ALT-801) and
chronic hepatitis B (HepTcell™). For more information on Altimmune,
please visit www.altimmune.com.
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Forward-Looking Statement
Any statements made in this press release
relating to future financial or business performance, conditions,
plans, prospects, trends, or strategies and other financial and
business matters, including without limitation, the timing of key
milestones for our clinical assets, the timing of the data readout
from the AdCOVID Phase 1 clinical trial in Q2 2021, the potential
immunization effects of AdCOVID, the potential of AdCOVID to block
SARS-CoV-2 transmission, the shipping and storage requirements for
AdCOVID, the prospects for regulatory approval, our ability to
manufacture AdCOVID for our clinical trials and commercial needs,
and commercializing or selling any product or drug candidates, are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. In addition, when or if
used in this press release, the words “may,” “could,” “should,”
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,”
“predict” and similar expressions and their variants, as they
relate to Altimmune, Inc. (the “Company”) may identify
forward-looking statements. The Company cautions that these
forward-looking statements are subject to numerous assumptions,
risks, and uncertainties, which change over time. Important factors
that may cause actual results to differ materially from the results
discussed in the forward looking statements or historical
experience include risks and uncertainties, including risks
relating to: potential impacts due to the COVID-19 pandemic such as
delays in regulatory review, manufacturing and supply chain
interruptions, access to clinical sites, enrollment, adverse
effects on healthcare systems and disruption of the global economy;
the reliability of the results of studies relating to human safety
and possible adverse effects resulting from the administration of
the Company’s product candidates; the Company’s ability to
manufacture clinical trial materials and commercial supply on the
timelines anticipated; the Company’s ability to secure
manufacturing approval from its SARS-CoV-2 cell licensor on the
timelines anticipated; and the success of future product
advancements, including the success of future clinical trials.
Further information on the factors and risks that could affect the
Company's business, financial conditions and results of operations
are contained in the Company’s filings with the U.S.
Securities and Exchange Commission, including under the heading
“Risk Factors” in the Company’s annual report on Form 10-K for the
fiscal year ended December 31, 2020 filed with
the SEC, which is available at www.sec.gov.
Altimmune Investor & Media Contacts:
Will
BrownChief Financial OfficerPhone:
240-654-1450wbrown@altimmune.com |
Stacey
JurchisonSr. Dir, Investor RelationsPhone :
410-474-8200sjurchison@altimmune.com |
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