Vaxart Reports Positive Preliminary Data from the Phase 1b Trial of its Oral Norovirus Vaccine Candidates in Elderly Adults
June 02 2022 - 8:30AM
Vaxart (NASDAQ: VXRT) today reported positive preliminary data from
its recently completed Phase 1b trial of its oral vaccine candidate
in subjects aged 55 – 80 years (NCT04854746).
Results of the trial show a robust immune response across all
doses, with a dose-dependent production of IgA antibody secreting
cells (ASCs), consistent with previous studies conducted in younger
populations. The results also demonstrate that the vaccine
candidate was well tolerated with a favorable safety profile.
These data support the continued development of Vaxart’s oral
norovirus vaccine candidate in adult populations, including elderly
adults, and add to the growing body of evidence supporting its
clinical utility. Vaxart is conducting a Phase 2 clinical challenge
study of its norovirus vaccine candidate in adult volunteers.
Norovirus is the leading cause of acute gastroenteritis that
produces vomiting and diarrhea among people of all ages. The World
Health Organization’s (WHO) Product Development for Vaccines
Advisory Committee has identified norovirus as a priority disease
for vaccine development.
The virus causes up to 21 million cases, 109,000
hospitalizations and 900 deaths annually in the United States.
Adults over the age of 65 years are especially vulnerable to
norovirus infection, with 7.5% of this population infected
annually. Norovirus also has a negative health economic impact,
which has been estimated to cost $10.6 billion annually in the
United States alone.
“Our norovirus vaccine candidate, the only investigational
norovirus vaccine formulated for oral administration, is optimized
for delivery to the gastrointestinal system, which is the site at
which norovirus enters the body,” said James F. Cummings, MD, Chief
Medical Officer at Vaxart. “The data reported today add to a
growing body of preclinical and clinical evidence demonstrating the
efficacy and safety of this approach in addressing the unmet and
critical need for an approved norovirus vaccine.”
Key findings from the Phase 1b study in elderly patients
include:
- Robust immune response across all doses, with a dose dependent
IgA ASC response
- IgA ASC responses were consistent with previous studies in
younger subjects
- All solicited adverse events were mild or moderate with
generally similar rates of events between the vaccine groups and
placebo
Vaxart is also reporting preliminary data from a Phase 1
boosting regimen of its norovirus vaccine candidate. These data
show that the candidate was able to successfully boost antibody
responses, with antibody responses trending better with
administration spread out over 3 months versus a shorter interval.
Vaxart has previously reported that booster administration at a
year post first dose was able to return antibody titers to levels
similar to what was observed after the first dose.
“The results reported today support the potential of our
Norovirus vaccine candidate in key patient populations and in a
variety of boosting schedules,” said Andrei Floroiu, Vaxart’s Chief
Executive Officer. “We are making progress in our Phase 2 trial,
which is designed to provide additional evidence validating the
safety and efficacy of our norovirus vaccine candidate. The data we
have generated across our clinical program increases our confidence
that our norovirus vaccine candidate may demonstrate first- and
best-in-class potential.”
References
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 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 Mark Herr Vaxart,
Inc. mherr@vaxart.com(203) 517-8957
Investor RelationsAndrew BlazierFINN
Partners IR@Vaxart.com(646) 871-8486
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