Cranbury, NJ, Dec. 8, 2014 (GLOBE NEWSWIRE) -- VaxInnate Corporation, a biotechnology firm pioneering a
breakthrough vaccine technology platform, today announced the
initiation of a double-blind, randomized, placebo-controlled Phase
1b/2 study of
VAX2012Q in healthy adults 65-75 years of age.
VAX2012Q is the Company's seasonal quadrivalent influenza
vaccine candidate, which incorporates a bacterial flagellin protein
designed to enhance the adaptive immune response to the vaccine.
This Phase 1b/2 study will evaluate the vaccine's safety and
immunogenicity in this elderly population. The Biomedical Advanced
Research and Development Authority (BARDA), part of the U.S.
Department of Health and Human Services, has funded the production
of VAX2012Q for use in this clinical study under contract No.
HHSO100201100011C.
"We believe our novel, differentiated vaccine platform and
production scalability is particularly well-suited to develop
vaccines for the elderly, whose immune systems typically require
greater stimulation, often in the form of increased antigen, to
generate a protective response. In this seasonal influenza trial,
we will evaluate several doses of VAX2012Q to determine the dose of
antigen for future development, and expect top-line data in the
second quarter of 2015," commented Wayne Pisano,
VaxInnate's president and chief executive officer.
"Traditional egg-based vaccine manufacturers have been
historically challenged to produce adequate supply as influenza
vaccine demand grows globally, and the added increase in antigen
needed for a high-dose elderly product further taxes production,"
Pisano continued. "We believe our recombinant manufacturing
technology and the dose-sparing attributes of our vaccine will
allow us to produce VAX2012Q in significantly greater quantities
and in less time than is possible with current vaccine production
methods, which will give us a strong advantage in this segment of
the market."
VAX2012Q is comprised of four seasonal influenza strains, each
fused to a flagellin protein, which acts as a toll-like
receptor (TLR) ligand. The TLR class of proteins is known
to activate the innate immune system, which in turn enhances the
adaptive immune response to vaccines. In a previous clinical study,
VAX125, a vaccine comprised of one seasonal influenza H1N1 strain,
was shown to elicit a robust immune response in the
elderly.1
This Phase 1b/2 study will enroll up to 200 healthy adults 65-75
years of age, who will be administered either VAX2012Q or placebo.
In addition to safety, which is the trial's primary objective, the
study will also assess the dose levels necessary to produce a
robust immune response in the majority of study participants.
Individuals will be monitored for one year following their
vaccination to assess long-term safety.
VAX2012Q recently
reported positive top-line results from a Phase 1 study of 316
healthy adults 18-40 years of age, showing that doses as low as 2
mcg per component were immunogenic, with mean seroprotection rates
exceeding 90% for each of the four vaccine components at the
day 21 clinic visit. The vaccine was generally well-tolerated,
with mild to moderate arm pain the most commonly reported adverse
event.
Powerful Vaccine Technology
Platform
VaxInnate's technology platform is based on proprietary
toll-like receptor (TLR) technology, which potentiates the immune
response. The TLR technology genetically fuses vaccine antigens to
the bacterial protein flagellin, and this sequentially triggers the
innate and adaptive immune systems. Using this technology, vaccines
can be produced using low-cost, highly scalable recombinant DNA
techniques, thus avoiding many of the challenges of conventional
vaccine production. This technology has the potential for
production of significantly greater quantities of vaccine in
extremely rapid timeframes, with very low infrastructure costs.
About VaxInnate
VaxInnate is a privately held biotechnology company in Cranbury,
NJ that is pioneering a breakthrough technology platform for use in
developing novel and proprietary vaccines. Influenza vaccines
manufactured using this technology have demonstrated excellent
immunogenicity in the elderly population, a group that is typically
less responsive to influenza vaccines. VaxInnate's vaccines focus
on infectious diseases, including seasonal and pandemic influenza,
Clostridium difficile and dengue. VaxInnate's ongoing studies of
seasonal and pandemic flu vaccines are significantly funded under
Contract No. HHSO100201100011C with the Office of the Assistant
Secretary for Preparedness and Response, Biomedical Advanced
Research and Development Authority (BARDA), Department of Health
and Human Services (HHS).
To learn more about VaxInnate and to explore the company's
technology platform, please visit the website at www.vaxinnate.com.
Note:
1) Taylor, DN et al. Induction of a potent immune response in
the elderly using the TLR-5 agonist, flagellin, with a recombinant
hemagglutinin influenza-flagellin fusion vaccine (VAX125, STF2.HA1
SI). J.Vaccine; 29 (2011) 4897-4902.
CONTACT: Christine C. Mayer
VaxInnate Corporation
info@vaxinnate.com
Aline B. Schimmel
Scienta Communications
aschimmel@scientapr.com
