VAXART ANNOUNCES IT ENTERED INTO AN AGREEMENT WITH EMERGENT BIOSOLUTIONS FOR THE DEVELOPMENT AND MANUFACTURING OF ORAL CORONA...
March 18 2020 - 6:31AM
Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company
developing oral recombinant vaccines administered by tablet rather
than by injection, announced today that it has entered into an
agreement with Emergent BioSolutions Inc. (NYSE: EBS), whereby
Emergent will deploy its molecule-to-market contract development
and manufacturing (CDMO) services to help develop and manufacture
Vaxart’s experimental oral vaccine candidate for coronavirus
disease (COVID-19). Vaxart’s oral recombinant vaccine
candidate is based on its proprietary VAAST™ platform.
“I’m pleased that we are joining forces with an experienced
manufacturer such as Emergent to help advance our oral COVID-19
vaccine to the clinic,” said Wouter Latour, MD, chief executive
officer of Vaxart. “We believe an oral vaccine administered
using a room temperature-stable tablet may offer enormous
logistical advantages in the roll-out of a large vaccination
campaign, and Emergent is a great partner to help in this
endeavor.”
Under the terms of the agreement, development services will
begin immediately, and upon Vaxart’s election, Emergent is expected
to produce bulk cGMP vaccine allowing Vaxart to initiate a Phase 1
clinical study early in the second half of 2020. Emergent
will provide development services out of its Gaithersburg, MD
location and manufacture drug substance at its Bayview facility in
Baltimore, MD, designated a Center for Innovation in Advanced
Development and Manufacturing (CIADM) by the U.S. Department of
Health and Human Services.
“Emergent is pleased to deploy our nimble CDMO expertise to
support fellow innovators, like Vaxart, and advance an experimental
COVID-19 vaccine candidate,” said Syed T. Husain, senior vice
president and CDMO business unit head at Emergent BioSolutions. “We
look forward to applying our broad molecule-to-market services,
including our ability to work with a multitude of delivery systems,
execute under expedited timelines, and meet Vaxart’s potential need
for future scalability and large-scale capacity for commercial
quantities.”
About CoronavirusThe 2019 Novel Coronavirus
(COVID-19) is a virus (more specifically, a coronavirus) identified
as the cause of an outbreak of respiratory illness first detected
in Wuhan, China. Early on, many of the patients in the outbreak in
Wuhan, China reportedly had some link to a large seafood and animal
market, suggesting animal-to-person spread. However, a growing
number of patients reportedly have not had exposure to animal
markets, indicating person-to-person spread is occurring. At this
time, it’s unclear how easily or sustainably this virus is
spreading between people. The latest situation summary
updates are available on CDC’s web page 2019 Novel Coronavirus,
Wuhan, China.
About VaxartVaxart is a clinical-stage
biotechnology company focused on developing oral recombinant
protein vaccines based on its proprietary oral vaccine platform.
Vaxart’s vaccines are designed to generate broad and durable immune
responses that protect against a wide range of infectious diseases
and may also be useful for the treatment of chronic viral
infections and cancer. Vaxart’s vaccines are administered using a
convenient room temperature-stable tablet, rather than by
injection. Vaxart believes that tablet vaccines are easier to
distribute and administer than injectable vaccines and have the
potential to significantly increase vaccination rates. Vaxart’s
development programs include oral tablet vaccines that are designed
to protect against norovirus, seasonal influenza and respiratory
syncytial virus (RSV), as well as a therapeutic vaccine for human
papillomavirus (HPV). For more information, please visit
www.vaxart.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. All statements, other
than statements of historical facts, included in this press release
regarding our strategy, prospects, plans and objectives, results
from preclinical and clinical trials, commercialization agreements
and licenses, beliefs and expectations of management are
forward-looking statements. These forward-looking statements may be
accompanied by such words as “believe,” “could,” “potential,”
“will” and other words and terms of similar meaning. Examples of
such statements include, but are not limited to, statements
relating to Vaxart’s expectations and plans with respect to its
product development programs (including plans with respect to the
proposed Coronavirus vaccine program); Vaxart’s ability to develop
and commercialize its product candidates and expectations with
respect to clinical results and trial data; and Vaxart’s
expectations with respect to the important advantages it believes
its oral vaccine platform can offer over injectable alternatives,
particularly for mucosal pathogens such as norovirus, flu and RSV,
as well as coronaviruses such as SARS, MERS and the virus that
recently emerged in China. Vaxart may not actually achieve the
plans, carry out the intentions or meet the expectations or
projections disclosed in our forward-looking statements and you
should not place undue reliance on these forward-looking
statements. Actual results or events could differ materially from
the plans, intentions, expectations and projections disclosed in
the forward-looking statements. Various important factors could
cause actual results or events to differ materially from the
forward-looking statements that Vaxart makes, including Vaxart’s
decision whether or not to proceed with the development program
after the initial evaluation phase; the success of the planned
development program; the timing of and ability to obtain and
maintain regulatory approvals by the FDA or non-U.S. regulatory
authorities for Vaxart’s product candidates; even if approved by
the FDA or non-U.S. regulatory authorities, Vaxart’s product
candidates may not achieve broad market acceptance; Vaxart may
experience manufacturing issues and delays; and other risks
described in the “Risk Factors” sections of Vaxart’s Quarterly and
Annual Reports filed with the SEC. Vaxart does not assume any
obligation to update any forward-looking statements, except as
required by law.
CONTACT:
Brant BiehnVaxart650 550 3500bbiehn@vaxart.com
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