Vaxart Announces Publication of the Phase 1 Results of its Oral Norovirus Tablet Vaccine in Journal of Clinical Investigation...
July 12 2018 - 9:00AM
Business Wire
Vaxart, Inc. (Nasdaq:VXRT), a clinical-stage biotechnology
company developing oral recombinant vaccines that are administered
by tablet rather than by injection, today announced publication of
the comprehensive results of the previously disclosed Phase 1
clinical trial with its norovirus oral tablet vaccine in the
Journal of Clinical Investigation Insight.
The paper by Leesun, Kim, et al., “Safety and immunogenicity of
an oral tablet norovirus vaccine, a phase 1 randomized,
placebo-controlled trial”, highlights the benign safety profile of
the Vaxart vaccine and describes the generation of robust systemic
and mucosal immune responses, including mucosal IgA, memory B
cells, and serum blocking antibody titers (BT50), all potential
correlates of protection.
“Our oral tablet vaccine elicited a substantial serum antibody
response as well as a strong local intestinal immune response as
measured by mucosal homing B-cells and a greater than tenfold
increase in fecal IgA antibodies,” said Sean Tucker, Ph.D., founder
and chief scientific officer of Vaxart. “Local immunity in the gut
is likely to be a key factor in protection against norovirus
infection, and this data confirms our vaccine is uniquely
positioned to generate this type of response.”
The primary immunological endpoint of the study, an increase in
BT50 titers, was met in the high dose group with 78% of subjects
showing a greater than or equal to twofold rise after a single
immunization (P=0.0003). In addition, more than 80% of recipients
of the high dose vaccine developed mucosally-primed norovirus
specific circulating antibody secreting cells, IgA positive memory
B cells expressing the α4β7 gut homing receptor, and fecal IgA.
“Norovirus causes substantial morbidity and mortality all across
the globe, impacting populations of all ages in all walks of life.
We believe our tablet vaccine could provide an optimal solution to
help reduce the burden of disease in vulnerable populations such as
the elderly and the very young, as well as people at-risk in the
healthcare, travel and food industry,” said David Taylor, M.D.,
chief medical officer of Vaxart. “We look forward to initiating our
Norovirus vaccine Phase 1 safety and immunogenicity bivalent study
and Phase 2 monovalent challenge study in the coming months.”
About Norovirus
Norovirus is recognized as a leading cause of acute
gastroenteritis. It is a common intestinal infection that typically
lasts three to five days and is marked by watery diarrhea,
vomiting, abdominal cramps, nausea and sometimes fever. Symptoms
can be more severe in older adults and young children and may lead
to serious complications including death. Norovirus causes frequent
and widespread outbreaks in the military, food industry, travel
industry, child care facilities, elderly homes and healthcare
facilities.
The U.S. Centers for Disease Control and Prevention (CDC)
estimates that norovirus causes 19 to 21 million illnesses in the
United States each year, resulting in 56,000 to 71,000
hospitalizations and 570 to 800 deaths. In a recent John Hopkins
University study, researchers estimated healthcare costs of
norovirus at $4.2 billion and lost productivity costs at $56.2
billion globally. Currently there are no norovirus vaccines
approved by the U.S. Food and Drug Administration.
About Vaxart
Vaxart 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 the Vaxart’s ability to develop and commercialize its
product candidates and clinical results and trial data,. 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, 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; and the risks described in the
“Risk Factors” sections of Vaxart’s Quarterly Report filed on Form
10-Q for the quarter ended March 31, 2018 and of Vaxart’s other
periodic reports filed with the SEC. Vaxart does not assume any
obligation to update any forward-looking statements, except as
required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180712005178/en/
Stern Investor RelationsCarl Mauch,
212-362-1200vaxart@sternir.com
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Apr 2023 to Apr 2024