Vaxart Announces Acquisition of Second GMP Manufacturing Facility
01 Dezembro 2021 - 10:00AM
Vaxart, Inc. (NASDAQ: VXRT) has entered into an agreement with
Kindred Bioscience, Inc. (“KindredBio”) for the purchase of
KindredBio’s manufacturing equipment and sublease of its GMP (Good
Manufacturing Practices) manufacturing facility in Burlingame,
California, giving Vaxart control of its second GMP manufacturing
facility.
The transaction closed Tuesday, Nov. 30, 2021,
and Vaxart expects the facility to be operational for GMP
production in Q1 2022.
“This acquisition gives us greater
flexibility to manage our manufacturing needs by allowing
Vaxart to exercise more control over our quality control program
and the timing of our manufacturing activities,” said Andrei
Floroiu, Vaxart’s Chief Executive Officer.
“Vaxart is developing not only COVID-19 oral
tablet and norovirus vaccines but also oral tablet vaccines for
other diseases using our proprietary delivery platform. With this
second plant, we expect to have the clinical-scale manufacturing
capacity necessary to rapidly develop our multiple programs in
parallel,” Floroiu said.
Vaxart’s existing South San Francisco GMP
manufacturing facility and the Burlingame facility will manufacture
materials for Vaxart’s COVID-19 and norovirus oral vaccine tablets.
Vaxart recently began a Phase II study of its COVID-19 vaccine
candidate and has several Phase I studies of its norovirus vaccine
candidate underway.
The Burlingame facility, which can produce
biologic drug substances at up to 500L bioreactor scale, has been
used by Vaxart since April 2020 to produce COVID-19 and norovirus
vaccine clinical trial materials. It will also provide GMP
manufacturing capacity to support the development of additional
candidates in Vaxart’s vaccine portfolio.
About Vaxart Vaxart is a
clinical-stage biotechnology company developing a range of oral
recombinant vaccines based on its proprietary delivery platform.
Vaxart vaccines are designed to be administered using tablets that
can be stored and shipped without refrigeration and eliminate the
risk of needle-stick injury. Vaxart believes that its proprietary
tablet vaccine delivery platform is suitable to deliver recombinant
vaccines, positioning the company to develop oral versions of
currently marketed vaccines and to design recombinant vaccines for
new indications. Vaxart’s development programs currently include
tablet vaccines designed to protect against coronavirus, norovirus,
seasonal influenza, and respiratory syncytial virus (RSV), as well
as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s
first immune-oncology indication. Vaxart has filed broad domestic
and international patent applications covering its proprietary
technology and creations for oral vaccination using adenovirus and
TLR3 agonists.
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 Vaxart's strategy, prospects, plans
and objectives, results from pre-clinical and clinical trials,
commercialization agreements and licenses, and beliefs and
expectations of management are forward-looking statements. These
forward-looking statements may be accompanied by such words as
"should," "believe," "could," "potential," "will," "expected,"
"plan," and other words and terms of similar meaning. Examples of
such statements include, but are not limited to, statements
relating to Vaxart's ability to develop and commercialize its
product candidates, including its vaccine booster products;
Vaxart's expectations regarding clinical results and trial data;
and Vaxart's expectations with respect to the effectiveness of its
product candidates. Vaxart may not actually achieve the plans,
carry out the intentions, or meet the expectations or projections
disclosed in the 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
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement,
and/or completion dates for clinical trials, regulatory submission
dates, regulatory approval dates, and/or launch dates, as well as
the possibility of unfavorable new clinical data and further
analyses of existing clinical data; the risk that clinical trial
data are subject to differing interpretations and assessments by
regulatory authorities; whether regulatory authorities will be
satisfied with the design of and results from the clinical studies;
decisions by regulatory authorities impacting labeling,
manufacturing processes, and safety that could affect the
availability or commercial potential of any product candidate,
including the possibility that Vaxart's product candidates may not
be approved by the FDA or non-U.S. regulatory authorities; that,
even if approved by the FDA or non-U.S. regulatory authorities,
Vaxart's product candidates may not achieve broad market
acceptance; that a Vaxart collaborator may not attain development
and commercial milestones; that Vaxart or its partners may
experience manufacturing issues and delays due to events within, or
outside of, Vaxart's or its partners' control; difficulties in
production, particularly in scaling up initial production,
including difficulties with production costs and yields, quality
control, including stability of the product candidate and quality
assurance testing, shortages of qualified personnel or key raw
materials, and compliance with strictly enforced federal, state,
and foreign regulations; that Vaxart may not be able to obtain,
maintain, and enforce necessary patent and other intellectual
property protection; that Vaxart's capital resources may be
inadequate; Vaxart's ability to resolve pending legal matters;
Vaxart's ability to obtain sufficient capital to fund its
operations on terms acceptable to Vaxart, if at all; the impact of
government healthcare proposals and policies; competitive factors;
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. Contacts
Vaxart Media
Relations: |
Investor
Relations: |
Mark Herr |
Andrew Blazier |
Vaxart, Inc. |
FINN Partners |
mherr@vaxart.com |
IR@Vaxart.com |
(203) 517-8957 |
(646) 871-8486 |
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