Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced that it entered into an agreement with
Lonza for the manufacturing of AdCOVID™, Altimmune’s
next-generation, single-dose intranasal vaccine candidate for
COVID-19. Lonza is a leading global biopharmaceutical manufacturing
company with facilities in Europe, North America, and South Asia.
Alberto Santagostino, SVP, Head of Cell and Gene
Technologies for Lonza, commented, “We are deeply committed to
fighting this global pandemic and deploying our expertise and
resources to help vaccine developers like Altimmune meet commercial
manufacturing requirements for novel and promising vaccine
candidates. Lonza is proud to be well-positioned to support these
companies in their mission to serve such critical public health
needs.”
“We are excited about the potential of our
AdCOVID vaccine candidate and are actively focused on expanding our
network of strategic manufacturing partners to ensure Altimmune’s
commercial readiness to supply vaccine in 2021 should our clinical
data support this advancement,” said Dr. Vyjoo Krishnan, Ph.D.,
Vice President of Product Development for Altimmune. “Lonza is a
tremendous partner in this mission, with deep expertise and
experience in vector manufacturing and global world class
facilities capable of manufacturing AdCOVID at commercial
scale.”
AdCOVID is a single-dose COVID-19 vaccine
candidate that has the potential to be conveniently administered
via an intranasal spray. In addition to activating systemic
immunity (neutralizing antibodies and T cell responses) AdCOVID
stimulates a type of localized immunity called mucosal immunity,
which can act to prevent both SARS-CoV-2 virus infection and
transmission. In preclinical studies, AdCOVID produced a 29-fold
increase in mucosal IgA, well above the level associated with
protection observed in several clinical studies from influenza,
another respiratory virus.
Based on clinical experience with Altimmune’s
vaccine platform technology, AdCOVID is expected to provide durable
immunity of up to a year or more following a single dose and to
have an excellent tolerability and stability profile. Vaccine
stability is critical for efficient vaccine deployment and AdCOVID
is expected to be shipped without cold chain and permit common
refrigerated storage conditions at community-based vaccination
centers without the need for specialized freezer storage.
“We strongly believe there is a compelling need
for next-generation COVID-19 vaccines and are rapidly advancing our
development program for AdCOVID to meet this demand,” said Dr.
Vipin K. Garg, President and CEO of Altimmune. “Our agreement with
Lonza expands on our current clinical and commercial manufacturing
strategy for AdCOVID, aligning us with leaders in vaccine
manufacturing and positioning Altimmune for commercial-readiness in
2021. We plan to commence a clinical study of AdCOVID in the fourth
quarter, with a data readout from this study anticipated in the
first quarter of 2021.”
About Lonza
At Lonza, we combine technological innovation
with world class manufacturing and process excellence. Together,
these enable our customers to deliver their discoveries in the
healthcare, preservation, and protection sectors.
We are a preferred global partner to the
pharmaceutical, biotech and specialty ingredients markets. We work
to prevent illness and promote a healthier world by enabling our
customers to deliver innovative medicines that help treat or even
cure a wide range of diseases. We also offer a broad range of
microbial control solutions, which help to create and maintain a
healthy environment.
Founded in 1897 in the Swiss Alps, Lonza today
operates in 120 sites and offices in more than 35 countries. With
approximately 15,500 full-time employees, we are built from
high-performing teams and of individual employees who make a
meaningful difference to our own business, as well as the
communities in which we operate. The company generated sales of CHF
5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion. Find out
more at www.lonza.com and follow us on Twitter @LonzaGroup or
Facebook @LonzaGroupAG.
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.
About AdCOVID
AdCOVID is a single dose intranasal vaccine for
COVID-19 designed to offer several important advantages over other
vaccine approaches, including a broad immune response that includes
both systemic immunity (neutralizing antibody) and local immunity
(mucosal IgA, resident memory T cells) in the respiratory tract, a
durable immune response of a year or more, and the ability to ship
and store the vaccine conveniently and inexpensively.
By utilizing Altimmune’s proprietary intranasal
vaccine technology, AdCOVID has the potential to activate multiple
arms of the immune system as shown in recent preclinical studies
where potent serum neutralizing antibody and T cell responses were
induced in addition to a robust induction in mucosal immunity
against the spike protein of the virus. Importantly, the mucosal
immunity was characterized by IgA antibody and resident memory T
cell responses in the respiratory tract, both are believed to be
important in fighting infection.
Because intranasal dosing can stimulate local
mucosal immunity, AdCOVID is expected to guard the respiratory
tract from viral invasion and provide downstream protection against
viral spread. Local mucosal immunity may be essential for creating
sterilizing immunity that eliminates the last traces of viral
infection in the nasal cavity. Recent studies have shown that in
the absence of mucosal immunity, the nasal cavity may become a
reservoir for the coronavirus, potentially prolonging infection
while allowing for disease transmission. Importantly, nasal mucosal
immunity can only be achieved by administering a vaccine
intranasally.
AdCOVID also provides an easier route of
administration than an injection eliminating the need for
administration by trained medical personnel and may even allow for
self-administration. Finally, based on data from Altimmune’s other
platform vaccines (NasoVAX™ and NasoShield™) AdCOVID is
expected to have extended stability at room temperature allowing
for cold chain-free distribution of the vaccine where it can then
be stored in the common refrigerators found in community-based
doctor’s offices and pharmacies for two years or more. The simple
and convenient handling requirements may greatly increase the
number of people willing to take the vaccine.
Altimmune anticipates submitting an IND with
the U.S. Food and Drug Administration and commencing a
Phase 1 safety and immunogenicity trial of AdCOVID in the fourth
quarter of 2020.
Additional Information and
Disclaimer for Lonza
Lonza Group Ltd has its headquarters in Basel,
Switzerland, and is listed on the SIX Swiss Exchange. It has a
secondary listing on the Singapore Exchange Securities Trading
Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s
continuing listing requirements but remains subject to Rules 217
and 751 of the SGX-ST Listing Manual.
Certain matters discussed in this news release
may constitute forward-looking statements. These statements are
based on current expectations and estimates of Lonza Group Ltd,
although Lonza Group Ltd can give no assurance that these
expectations and estimates will be achieved. Investors are
cautioned that all forward-looking statements involve risks and
uncertainty and are qualified in their entirety. The actual results
may differ materially in the future from the forward-looking
statements included in this news release due to various factors.
Furthermore, except as otherwise required by law, Lonza Group Ltd
disclaims any intention or obligation to update the statements
contained in this news release.
Forward-Looking Statement of
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 initiation and timing of
the AdCOVID Phase 1 clinical trial in Q4 2020 and data readout in
Q1 2021, the potential immunization effects of AdCOVID, the
shipping and storage requirements for AdCOVID, our ability to
manufacture AdCOVID beginning this year, our ability to achieve
commercial-readiness for AdCOVID in 2021 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 secure
regulatory approval for its AdCOVID investigational new drug
application submission to the U.S. Food and Drug Administration,
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 March 31, 2020 filed with the SEC, which are available at
www.sec.gov.
Altimmune Contact Details:
Will BrownChief Financial OfficerPhone:
240-654-1450wbrown@altimmune.com
Stacey JurchisonSenior Director, Investor Relations &
Corporate CommunicationsPhone:
410-474-8200sjurchison@altimmune.com
Warren RizziSard Verbinnen & Co.Phone:
212-687-8080altimmune-svc@sardverb.com
Lonza Contact
Details:
Dr. Sanna FowlerHead of External
CommunicationsLonza Group LtdTel +41 61 316
8929sanna.fowler@lonza.com
Dirk OehlersInvestor RelationsLonza Group LtdTel
+41 79 421 1609dirk.oehlers@lonza.com
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