|[January 09, 2014]
Vaxart's Oral H1N1 Influenza Vaccine Generates Protective Immunity
SAN FRANCISCO --(Business Wire)--
Vaxart, a privately held company developing recombinant vaccines that
are administered by tablet rather than by injection, today announced
positive safety and immunogenicity data from a phase Ib clinical
dose-ranging study with its oral H1N1 seasonal influenza vaccine
candidate. This study follows a phase I study, the positive results of
which were announced in June 2013.
In this latest study, the Vaxart oral H1N1 influenza vaccine induced
anti-hemagglutinin antibody responses in 88 percent of subjects.
Four-fold increases in neutralizing antibodies as determined by
hemagglutination inhibition assay (HAI) and microneutralization (MN)
assay were detected in 45 and 55 percent of subjects, respectively.
"These results demonstrate that the Vaxart oral vaccine can protect
against flu and represent a significant milestone on our way to the
world's first oral seasonal flu vaccine," said Vaxart CEO Wouter Latour,
MD. "We are accelerating the program and look forward to the day when
the 'flu shot' can be administered conveniently as a simple tablet at
the work place, the ocal pharmacy, or even at home after receiving
Vaxart's room temperature stable tablet vaccine by mail."
In its next step toward developing a complete oral quadrivalent seasonal
influenza vaccine, Vaxart plans to conduct further clinical studies in
2014 with its tablet vaccines for H1N1 influenza A, H3N2 influenza A and
"The success of public vaccination programs depends to a large extent on
logistics, and each year the annual flu vaccination campaign puts the
system to the test," said Vaxart chief medical officer David Liebowitz,
MD, PhD. "Currently, about 45 percent of more than 300 million eligible
Americans are vaccinated against flu each year, according to recent
figures from the CDC. A tablet vaccine would remove multiple bottlenecks
in distribution and dramatically improve access and acceptance."
Vaxart's H1N1 influenza vaccine candidate has demonstrated an excellent
safety profile in all studies to date, with no vaccine-related
significant adverse events. Adverse events that did occur were all mild.
Vaxart produces its influenza vaccine tablets utilizing
industry-standard cell-culture and solid-dose manufacturing processes,
which enable manufacturing and distribution of the annually updated
vaccine to the public considerably faster than egg-based influenza
vaccine manufacturing technologies.
Vaxart is a privately owned company developing oral recombinant vaccines
based on its proprietary delivery platform. The Vaxart platform is
suitable to deliver any protein vaccine antigen such as those used in
currently marketed influenza, hepatitis B and human papilloma virus
(HPV) blockbuster vaccines. Care Capital of Princeton is the lead
investor in the company and its largest shareholder. For more
information, please visit www.vaxart.com.
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