Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, announced today that it has retained Summit Biosciences, a
world-wide leader in nasal spray pharmaceuticals, to manufacture a
metered nasal spray presentation of AdCOVID, its intranasal
COVID-19 vaccine candidate. AdCOVID is an adenovirus-vector vaccine
designed to stimulate a broad immune response following a single
vaccination that includes both systemic immunity (neutralizing
antibody) and local immunity (mucosal IgA and resident memory T
cells) in the nasal cavity and respiratory tract.
“As we continue to build our manufacturing
consortium and progress the development of AdCOVID, we are pleased
to partner with Summit Biosciences to manufacture AdCOVID in a
customized multidose nasal spray delivery device. We expect this
device may be a convenient and efficient option when vaccinating
patients in high-demand settings where our vaccine candidate’s
anticipated room temperature stability profile will also be
important,” said Vipin K. Garg, President and Chief Executive
Officer of Altimmune. “In addition, Altimmune will continue to
produce a single dose presentation of AdCOVID to provide
alternative forms of administration. Summit Biosciences has
expertise in intranasal product innovation, and we are excited to
align with their highly experienced team in our fight against
COVID-19.”
Gregory Plucinski, President and COO, Summit
Biosciences, said, “I am pleased that Altimmune, a recognized
leader in intranasal vaccine development, selected Summit in this
exciting endeavor. Summit has a proven track record in bringing
nasal spray medicines from concept to market with its
state-of-the-art capabilities that are ideal for this program.
Together, we will combine our respective expertise and capabilities
with the goal of ultimately introducing a potentially novel,
needle-free, nasal spray vaccine for the SARS-CoV-2 pandemic.”
AdCOVID is currently being evaluated in a Phase
1 clinical trial. The Phase 1 trial is evaluating the safety and
immunogenicity of AdCOVID in 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 data
readout from this Phase 1 trial in Q2 2021.
While traditional vaccines delivered by an
intramuscular injection can stimulate systemic immunity as measured
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, thereby potentially offering an important early 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.
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
preclinical efficacy studies, AdCOVID provided 100% protection
against lethal SARS-CoV-2 challenge and a 3-log reduction in viral
titer in the nasal cavity and respiratory tract.
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 Summit Biosciences
Founded in 2009, Summit Biosciences, Inc. of
Lexington, KY is a privately-held, specialized pharmaceutical
company focused on developing, manufacturing and commercializing
generic and innovative nasal spray medicines. It collaborates on
the development of products with its clients and manufactures them
at an industrial scale primarily for commercialization in the US
and Europe. For more information on Summit Biosciences, please
visit
www.Summitbiosciences.com.
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 for Altimmune
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.
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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