Vaxart Doses First Subject in Phase 1 Trial of Its Norovirus Vaccine Candidate in Lactating Mothers
November 02 2023 - 8:00AM
Vaxart, Inc. (Nasdaq: VXRT) today announced it has dosed the first
subject in its Phase 1 clinical trial evaluating Vaxart’s oral pill
bivalent norovirus vaccine candidate focused on lactating mothers.
“Initiating this study is an important step
toward Vaxart’s goal of developing a vaccine that may reduce the
significant global health threat norovirus poses to children under
5 years of age,” said Dr. James F. Cummings, Vaxart’s Chief Medical
Officer. “We believe an oral norovirus vaccine pill may make it
possible for mothers to protect their infants against this highly
contagious virus for which there currently is no approved
vaccine.”
Norovirus sickens approximately 21 million
people in the United States each year, and 15% of children under
age 5 contract 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 they are
much more common in the developing world.
About the VXA-NVV-108 Clinical
Trial
The Phase 1, multicenter, randomized,
double-blind, placebo-controlled single dose, dose-ranging study is
designed to evaluate the safety, tolerability, and immunogenicity
of orally administered bivalent GI.1/GII.4 norovirus vaccine in
healthy lactating females of at least 18 years of age and their
breast-feeding infants (aged 30 days to 11 months). The study is
expected to enroll approximately 76 subjects at seven sites in
South Africa. Subjects will be randomized into high- or low-dose
vaccine (N=30 for each arm) or placebo (N=16). The primary
endpoints are:
- Frequency, duration and severity of
solicited symptoms of reactogenicity (local and systemic) for one
week following study drug dose;
- Frequency, duration and severity of
unsolicited treatment-emergent adverse events (TEAEs), serious AEs
(SAEs), adverse events of special interest (AESIs) and new onset of
chronic illness (NOCIs) through the active period (four weeks post
dose);
- Serum VP1-specific (GI.1 and GII.4)
IgA on Day 1 (baseline), Day 8 and Day 29 (four weeks post last
dose);
- Breastmilk VP1-specific (GI.1 and
GII.4) IgA on Day 1 (baseline), Day 8 and Day 29 (four weeks post
last dose).
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 and the timing of such results, 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 the timing of
receiving and reporting such 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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