Altimmune Commences Enrollment in Phase 1 Clinical Trial of AdCOVID™ -- a Needle-Free, Single-Dose Intranasal COVID-19 Vac...
February 25 2021 - 7:03AM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced that it has commenced enrollment in a
Phase 1 clinical trial of AdCOVID, a single-dose intranasal
COVID-19 vaccine candidate. AdCOVID is an adenovirus-vector vaccine
designed to stimulate a broad immune response including both
systemic immunity (neutralizing antibody) and local immunity
(mucosal IgA and resident memory T cells) in the nasal cavity and
respiratory tract.
The Phase 1 clinical trial will evaluate the
safety and immunogenicity of AdCOVID in up to 180 healthy adult
volunteers between the ages of 18 and 55. Subjects will receive
AdCOVID at one of three dose levels administered as a nasal spray.
In addition to the primary study endpoint of safety and
tolerability, the immunogenicity of AdCOVID will be evaluated by
serum IgG binding and neutralizing antibody titers, mucosal IgA
antibody from nasal samples, and T cell responses. Altimmune
anticipates having a full data readout from this Phase 1 study in
Q2 2021.
“The commencement of our Phase 1 clinical trial
of AdCOVID is an important milestone for our company and the global
healthcare community in our fight against the SARS-CoV-2 virus,”
said Dr. Scott Harris, Chief Medical Officer of Altimmune. “We
believe that our expertise in intranasal vaccine development will
help us bring to market a novel intranasal COVID-19 vaccine with
important attributes that could potentially help prevent further
transmission of the virus. Delivering vaccine directly to the nasal
cavity may stimulate a specialized type of immunity called ‘mucosal
immunity,’ which has been shown in a preclinical study to provide
sterilizing immunity, that is, complete clearance of the virus from
the respiratory tract. As the rise of new variants of the
SARS-CoV-2 virus is particularly troubling, to stop mutations of
the virus we must stop replication and transmission, and we believe
AdCOVID could play an essential role in this endeavor.”
While traditional vaccines delivered by an
intramuscular injection can stimulate systemic immunity in the
blood, they have not been shown to induce mucosal immunity in the
nasal cavity, which may be critical for blocking transmission of
the virus. AdCOVID is designed to deliver vaccine directly to the
site of viral entry and replication to stimulate mucosal and
cellular immunity in the nasal cavity and respiratory tract –
potentially offering a first line of defense against the SARS-CoV-2
virus. The ability to stimulate mucosal and resident T cell
immunity in the respiratory tract would be a key differentiator for
AdCOVID and may play a critical role in blocking transmission of
the SARS-CoV-2 virus.
“While the roll out of currently available
vaccines is an important first step in our efforts to slow the
pandemic, there remains a critical need for vaccines that provide
mucosal immunity,” said Scot Roberts, Ph.D., Chief Scientific
Officer of Altimmune. “As pioneers in intranasal vaccine
development, we believe AdCOVID has the potential for many
advantages over currently available vaccines, including, intranasal
dosing and ease of distribution and storage, if the product is
shown to have extended stability at room temperature, in addition
to the potential ability to block transmission of the virus.”
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 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.
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.
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, and the prospects for regulatory approval, 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 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.
Investor & Media Contacts:
Will
BrownChief Financial OfficerPhone:
240-654-1450wbrown@altimmune.com |
Stacey
JurchisonSr. Dir, Investor RelationsPhone :
410-474-8200sjurchison@altimmune.com |
Photos accompanying this announcement are available
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