Vaxart oral tablet vaccine provided 39% reduction in flu illness
compared to 27% for Fluzone®
Strong β7+ plasmablasts response in Vaxart
vaccinees was highly correlated with protection
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Oct. 4, 2018--
Vaxart, Inc., a clinical-stage biotechnology company developing oral
recombinant vaccines that are administered by tablet rather than by
injection, announced it will present new data from the Phase 2 Challenge
Study of its H1 influenza oral tablet vaccine at IDWeek 2018 in San
Francisco on Saturday, October 6, 2018.
“These latest results show that our vaccine elicited a significant
expansion of mucosal homing receptor α4β7+ (β7+)
plasmablasts to approximately 60% of all activated B cells, while
Fluzone only maintained baseline levels of 20%. We believe these β7+
plasmablasts are a key indicator of a protective mucosal immune response
and a unique feature of our oral recombinant vaccines,” said Sean Tucker
Ph.D., chief scientific officer of Vaxart. “Further analysis of the data
also confirm that, while our vaccine also generated protective
hemagglutinin inhibition (HAI) antibodies in serum like conventional
injectable flu vaccines, it primarily protected through the mucosal
mechanism, providing a robust 39% reduction in illness versus placebo
overall. In contrast, Fluzone, the market-leading injectable
quadrivalent influenza vaccine, only provided a 27% reduction in illness
versus placebo, while protecting primarily through HAI antibodies.”
Vaxart previously reported only 37% of study participants receiving the
Vaxart vaccine developed influenza infection after challenge, compared
to 44% of those receiving Fluzone and 71% of those receiving placebo.
The new Phase 2 data to be presented at IDWeek 2018 showed that the
Vaxart vaccine generated a strong increase in mucosal homing antibody
secreting cells, or β7+ plasmablasts. In protected study
participants, the percentage of β7+ plasmablasts in
recipients of the Vaxart vaccine nearly doubled, whereas the percentage
of β7+ plasmablasts in Fluzone recipients remained unchanged.
“In all our studies to date, we have seen both systemic and mucosal
immune responses, and this latest data provides solid evidence that our
vaccines indeed protect through mucosal immunity, the first line of
defense against mucosal infections,” said Wouter Latour, M.D., chief
executive officer of Vaxart. “We believe this clearly differentiates our
oral vaccines from conventional injectable vaccines, and strongly
suggests that vaccines based on Vaxart’s proprietary vector adjuvant
system could be optimal to protect against mucosal pathogens, including
some of the major public health threats such as flu, norovirus, RSV and
many others.”
The Phase 2 study was completed with support from Biomedical Advanced
Research and Development Authority (BARDA). Vaxart received a $13.9
million contract from BARDA in September 2015 to support the advanced
development of more effective influenza vaccines to ultimately improve
seasonal and pandemic influenza preparedness. The contract was increased
to $15.7 million in 2017.
The 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 Influenza
The 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. 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 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, clinical results and trial data,
Vaxart’s ability to obtain and maintain regulatory approval of its
product candidates and Vaxart’s reliance on third party funding and
grants. 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
the Registration Statement on Form S-4 (file no. 333-222009) and of
Vaxart’s 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/20181004005175/en/
Source: Vaxart, Inc.
Carl Mauch
Stern Investor Relations
212-362-1200
vaxart@sternir.com
