Vaxart Announces Publication of the Phase 1 Results of its Oral Norovirus Tablet Vaccine in Journal of Clinical Investigation Insight

SOUTH SAN FRANCISCO, Calif.–(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
”, 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

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.


Stern Investor Relations
Carl Mauch, 212-362-1200