Novavax Announces Positive Data From Phase 2 Trial of Quadrivalent Seasonal Influenza VLP
July 30 2015 - 8:31AM
GAITHERSBURG, Md., July 30, 2015
(GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage
vaccine company focused on the discovery, development and
commercialization of recombinant nanoparticle vaccines and
adjuvants, today announced positive top-line data from a Phase 2
clinical trial of its recombinant quadrivalent seasonal influenza
virus-like particle (VLP) vaccine candidate (Seasonal Influenza
VLP). This project has been funded in whole or in part with Federal
funds from the Office of the Assistant Secretary for Preparedness
and Response, Biomedical Advanced Research and Development
Authority, Department of Health and Human Services under the
Company's contract with HHS-BARDA (HHSO100201100012C). The trial
demonstrated that the Seasonal Influenza VLP vaccine candidate was
well-tolerated with no vaccine-related serious adverse events. The
trial met its immunogenicity targets and demonstrated potential to
meet the Center for Biological Evaluation and Research (CBER)
criteria for accelerated approval.
Novavax' technology platform enables
the creation of recombinant, strain-specific VLPs. Novavax'
Seasonal Influenza VLP consists of VLPs representing four different
strains of influenza virus, each expressing strain-specific
hemagglutinin and neuraminidase antigens. This dose-ranging
clinical trial was designed to evaluate the safety and
immunogenicity of the Seasonal Influenza VLP in 400 healthy
adults. The primary outcomes of the trial assessed safety and
tolerability of the Seasonal Influenza VLP and quantified immune
responses to each of the four influenza strains based on
hemagglutination-inhibiting antibody titers. The secondary outcomes
evaluated neuraminidase-inhibiting antibody titers for all four
influenza strains.
"Titers of antibodies that inhibit
hemagglutination by the influenza virus - called
hemagglutination-inhibiting or HAI antibodies - remain the
best-accepted correlates of the protection provided by influenza
vaccines. We were very pleased to see that our Seasonal Influenza
vaccine candidate elicited increases in HAI titers for all four
viral strains that would allow our vaccine to fulfill CBER's
criteria for accelerated approval," said Louis F. Fries III, M.D.,
Chief Medical Officer, Novavax. "Novavax has made a concerted
effort to improve the antigens in our Seasonal Influenza vaccine.
In particular, for the two viral strains (out of the four) for
which we had sought immunogenic improvement, we showed robust HAI
titer responses, approximately 50% greater than those in our prior
phase 2 trial. Further, we measured neuraminidase-inhibiting (NAI)
antibody responses against seasonal influenza viruses for the first
time, and were able to detect significant NAI antibody responses to
all four influenza strains, including strong responses against the
B virus strains."
Novavax President and CEO, Stanley C.
Erck, said, "These positive topline data from the Phase 2 trial of
our Seasonal Influenza vaccine candidate represent an important
achievement in this program. We look forward to a complete review
of these data with our partner BARDA to determine next steps in the
development of this product. Our collaboration with BARDA also
includes the development of our novel H7N9 Influenza vaccine
candidate in combination with Matrix-M(TM). We expect the next
steps in our collaboration will be the initiation of a Phase 2
clinical trial of the H7N9 vaccine candidate in the adult
population in the first quarter of 2016."
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a
clinical-stage vaccine company committed to delivering novel
products to prevent a broad range of infectious diseases. Our
recombinant nanoparticles and Matrix-M(TM) adjuvant technology are
the foundation for groundbreaking innovation that improves global
health through safe and effective vaccines. Additional information
about Novavax is available on the Company's
website, novavax.com.
Contact:
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Novavax, Inc. via Globenewswire
HUG#1942354
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From Apr 2023 to Apr 2024