New Data from Phase 2 Flu Challenge Study Demonstrates Vaxart’s Oral H1 Flu Vaccine Generated Protective Mucosal Immunity
October 04 2018 - 8:00AM
Business Wire
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
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/
Carl MauchStern Investor Relations212-362-1200vaxart@sternir.com
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Sep 2023 to Sep 2024