Altimmune Announces FDA Clearance of AdCOVID™ IND Application
February 17 2021 - 7:02AM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced that the U.S. Food and Drug Administration
(FDA) has cleared the Company’s Investigational New Drug (IND)
application for its Phase 1 clinical trial of AdCOVID, a novel,
single-dose, intranasal COVID-19 vaccine candidate. Altimmune
expects to commence patient enrollment in the Phase 1 clinical
trial in the coming week.
“We believe deployment of intranasal vaccines
like AdCOVID will be essential to a successful global response to
the pandemic,” said Vipin K. Garg, President and Chief Executive
Officer of Altimmune. “FDA clearance of the IND marks an important
step in developing a safe and effective vaccine designed to
stimulate mucosal as well as systemic immunity following intranasal
administration. Developing vaccines that can effectively prevent
transmission is a growing imperative to block the spread of disease
and combat the emergence of new variants. We look forward to the
data from this trial in the coming weeks.”
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. Volunteers 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.
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 initiation and timing of
the AdCOVID Phase 1 clinical trial in the coming week, the timing
of the data readout for the AdCOVID Phase 1 clinical trial, 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, 2019 and quarterly
report on Form 10-Q for the quarter ended September 30, 2020 filed
with the SEC, which are available at www.sec.gov.
Investor & Media Contacts:
Will
Brown |
Stacey
Jurchison |
Chief Financial Officer |
Sr. Dir, Investor Relations |
Phone: 240-654-1450 |
Phone : 410-474-8200 |
wbrown@altimmune.com |
sjurchison@altimmune.com |
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