Vaxart Announces Collaborative Funding from Leading Foundation to Study Its Norovirus Vaccine Candidate in Breastfeeding Mothers
December 01 2022 - 8:00AM
Vaxart, Inc. (Nasdaq: VXRT) today announced it will commence a new
study of Vaxart’s oral pill norovirus vaccine candidate focused on
protecting breastfeeding mothers and their infants.
The study will receive significant funding and
support from the Bill & Melinda Gates Foundation (“Gates
Foundation”). This funding follows Vaxart’s previous collaboration
with Duke University on a pre-clinical COVID-19 transmission study
also funded by the Gates Foundation.
“Currently, there are no approved vaccines that
prevent norovirus, which is responsible for a $10.5 billion annual
disease burden in the United States alone. Vaxart’s oral norovirus
vaccine pill may make it possible for mothers to protect their
infants against this highly contagious disease that has serious
health consequences,” said Dr. James Cummings, Vaxart’s Chief
Medical Officer. “We believe this is just one part of the broader
promise of our norovirus vaccine program, which could be of great
benefit to at-risk populations such as the elderly, children under
age 5, the military, first responders and healthcare workers, both
here in the U.S. and globally.”
The study will examine whether Vaxart’s vaccine
candidate induces antibodies in the breast milk of lactating
mothers and whether infants up to 6 months of age can acquire those
antibodies. Vaxart believes there are potential advantages to this
approach. Young children have an immature immune system that makes
them particularly susceptible to highly contagious diseases, and
direct immunization can be challenging. Passive transfer of
antibodies from mother to infant that are induced in milk may
protect breastfeeding infants from infectious pathogens.
“By triggering mucosal immunity in addition to
protecting those vaccinated, our vaccines may also reduce
transmission - the key mechanism by which viral infections spread,
further increasing their overall effect on the broader population.
This study investigates inducing mucosal immunity at an important
site that ultimately might result in positively impacting
transmission,” said Andrei Floroiu, Vaxart’s Chief Executive
Officer. “We are pleased with the funding and support from the
Gates Foundation, which will help realize the potential impact of
our vaccine technology on global public health.”
Norovirus sickens approximately 21 million
people in the United States each year, and 15% of children under
age 5 catch norovirus annually. This would translate into about 3
million sets of parents needing to take time from work
(approximately 2.2 days on average) to care for their children.
Globally, in countries that have adopted a rotavirus vaccine
program, norovirus has become the leading cause of pediatric
gastroenteritis in health care settings.1 Pediatric deaths in the
United States due to norovirus are rare, but much more common in
the developing world.
As a grant recipient, Vaxart has agreed to a
global access commitment for use of its vaccine candidate, if
proven effective and approved, in breastfeeding mothers from low-
and middle-income countries.
Vaxart is also currently studying its norovirus
vaccine candidate in a challenge study that will provide the
vaccine 30 days before exposure to actual norovirus, and then
determine whether people get infected or have severe
gastroenteritis.
1 Shah and Hall, Infect Dis Clin North Am. 2018 Mar; 32(1):
103-118.
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 pills that
can be stored and shipped without refrigeration and eliminate the
risk of needle-stick injury. Vaxart believes that its proprietary
pill 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
pill 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 preclinical 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,” “anticipate,” “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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