Vaxart, Inc. (VXRT), a clinical-stage biotechnology company
developing oral recombinant vaccines administered by tablet rather
than by injection, announced today that the results from its H1
influenza oral tablet vaccine challenge study were published in the
Lancet Infectious Diseases, January 21, 2020 and currently
available at doi.org/10.1016/S1473-3099(19)30584-5. Topline results
had been reported previously.
The study demonstrated a single dose with the Vaxart oral tablet
H1 influenza vaccine was well tolerated and provided statistically
significant protection against H1 influenza infection in the human
challenge model. Efficacy results trended favorably
when compared to Fluzone, an injectable quadrivalent influenza
vaccine (QIV) and the active comparator in the study.
“If the results of the oral H1N1 influenza vaccine in this
clinical trial can be reproduced with a quadrivalent mixture of
strains this would revolutionize immunization against influenza,
which after all is a mucosal disease,” said Stanley Plotkin,
MD.
Dr. Stanley A. Plotkin is Emeritus Professor of the University
of Pennsylvania and Adjunct Professor of the Johns Hopkins
University. Dr. Plotkin has developed several vaccines including
the rubella vaccine now in standard use throughout the world and a
recently licensed pentavalent rotavirus vaccine. He has also been
involved in other vaccine development programs including anthrax,
oral polio, rabies, varicella, and cytomegalovirus.
“These results provide clinical proof-of-concept for Vaxart’s
proprietary technology being able to make an oral vaccine that is
at least as protective as Sanofi’s Fluzone,” said Sean Tucker,
Ph.D., chief scientific officer of Vaxart. “The results of the
clinical study also demonstrated that our oral tablet vaccine
primarily protects through mucosal immunity, a potential key factor
for improving influenza vaccine performance.”
Data from the Phase 2 influenza A challenge study demonstrated
that Vaxart’s oral tablet influenza vaccine generated a 39 percent
reduction in clinical disease relative to placebo, compared to a 27
percent reduction by Fluzone. It also reduced infection
rates by 47 percent, compared to 43 percent by Fluzone. The
tablet vaccine showed a favorable safety profile, similar to
placebo.
“Influenza continues to be a serious public health problem
affecting all age groups and causing severe illness and sometimes
death in high-risk populations. A convenient and effective tablet
vaccine may significantly increase current vaccination rates,
generating important public health benefits for at-risk groups and
the population as a whole,” said Wouter Latour, M.D., M.B.A., chief
executive officer of Vaxart. “These results also confirm the value
of our oral vaccine platform, particularly for mucosal pathogens
such as flu, norovirus, RSV, as well as coronaviruses such as SARS,
MERS and the virus that recently emerged in China.”
The Phase 2 influenza A challenge trial was a randomized,
double-blind study consisting of three groups. Subjects received
either a single dose of the Vaxart oral tablet vaccine and a
placebo intramuscular injection, a QIV injection and a placebo
tablet, or a double placebo. Subjects were challenged intranasally
with homologous A strain influenza virus 90-132 days after
vaccination. The main objective of the study was to evaluate the
percentage of subjects protected by the Vaxart oral tablet vaccine
against influenza illness, measured as a reduction in clinical
symptoms and laboratory-confirmed homologous influenza A
infections, compared to QIV and placebo.
The Phase 2 study was completed with support from the Office of
Biomedical Advanced Research and Development Authority (BARDA).
Vaxart received a total of $15.7 million under a contract from
BARDA to support the advanced development of more effective
influenza vaccines to ultimately improve seasonal and pandemic
influenza preparedness.
This project has been funded in whole or in part with federal
funds from the Department of Health and Human Services’ Office of
the Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority under Contract No.
HHSO100201500034C.
About InfluenzaThe flu is a contagious
respiratory illness caused by influenza viruses that infect the
nose, throat and sometimes the lungs. It can cause mild to severe
illness, and at times, can lead to death. The best way to prevent
the flu is by getting a flu vaccine each year. While the impact of
flu varies, it places a substantial burden on the health of people
in the United States. The U.S. Centers for Disease Control and
Prevention (CDC) estimates that influenza has resulted in between
9.2 million and 60.8 million illnesses, between 140,000 and 710,000
hospitalizations and between 12,000 and 56,000 deaths annually
since 2010.
For further information on influenza, its burden on human health
and vaccine development, please visit the CDC website at
www.cdc.gov/flu/.
About VaxartVaxart 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’s
intention to continue its efforts to advance its oral tablet
seasonal flu vaccine; and Vaxart’s expectations with respect to the
important advantages it believes its oral vaccine platform can
offer over injectable alternatives, particularly for mucosal
pathogens such as norovirus, flu and RSV, as well as
coronaviruses such as SARS, MERS and the virus that recently
emerged in China. 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; that Vaxart may experience manufacturing
issues and delays; 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.
CONTACT:
Brant BiehnVaxart, Inc.(650) 550-3500bbiehn@vaxart.com
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