DGAP-News: New England Journal of Medicine Publishes Positive Data From Clinical Trial of Novavax' Vaccine Against H7N9 Avian Flu
(firmenpresse) - Novavax, Inc.
13.11.2013 23:01
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-- Data are industry's first from clinical trial of vaccine against A(H7N9)
strain of influenza
-- 81% of 5ug adjuvanted vaccine recipients had protective HAI levels
-- 97% of 5ug adjuvanted vaccine recipients had anti-neuraminidase antibody
responses
-- Protective levels achieved from vaccinations within 116 days of the
announced outbreak of novel lethal H7N9 virus
-- Dose-sparing formulation shows significant potential utility in the event
of a pandemic
-- Vaccine safety consistent with previously tested adjuvanted pandemic
vaccines
ROCKVILLE, Md., 2013-11-13 23:01 CET (GLOBE NEWSWIRE) -- Novavax, Inc.
(Nasdaq:NVAX) today announced that positive clinical data for the company's
virus-like particle (VLP) vaccine candidate against A(H7N9) influenza were
published online in the Correspondence section of The New England Journal of
Medicine. The correspondence can be found at:
http://www.nejm.org/doi/full/10.1056/NEJMc1313186 and will appear in the
December 26, 2013 print edition.
The study, conducted in 284 adult male and female subjects, examined the safety
and immunogenicity of two administrations of Novavax' A(H7N9) VLP vaccine
candidate on day 0 and day 21. Subjects were administered either placebo, 15 or
45 ug of vaccine alone, or 5 or 15ug of vaccine with either 30 or 60 ISCO(r)
units of the saponin-based ISCOMATRIX(r) adjuvant, developed by CSL Limited in
Australia. Serology was assessed at Days 0, 21 and 35 post-first immunization.
The Novavax A(H7N9) VLP vaccine candidate was generally well tolerated, and the
safety was in line with the company's previous findings with its influenza VLP
antigens using ISCOMATRIX(r) adjuvant. Overall, as with other adjuvanted
influenza vaccines, there was an increase in transient local and systemic
reactions in the adjuvanted in contrast to the non-adjuvanted formulations, but
there were no treatment-related SAEs in the active groups. The A(H7N9) VLP
vaccine candidate induced hemagglutination-inhibition (HAI) antibody titers of>=1:40 (seroprotection) and a four-fold HAI antibody rise (serconversion)
against H7N9 in 81% of subjects at the 5mg dose of A(H7N9) antigen with 60
ISCO(r) units of adjuvant, and 73% of subjects receiving 5mg dose of A(H7N9)
antigen with either adjuvant dose level. The vaccine also elicited
anti-neuraminidase (NA) antibodies against N9 in 92 to 97% of subjects
receiving 5mg with either adjuvant dose level.
The A(H7N9) influenza strain has emerged recently as a potential pandemic
concern. Less than ten (10) days after the Chinese Health authorities announced
an outbreak of this novel avian influenza in humans (137 total confirmed cases,
including 45 deaths, to date), Novavax obtained the genetic sequence of the
strain and commenced production of a recombinant vaccine. Clinical trial
material was manufactured and released in late June 2013 with the first doses
injected in humans in early July 2013. Less than four months after the novel
A(H7N9) virus had been identified and sequenced, Novavax' H7N9 VLP vaccine,
with the higher-dose of ISCOMATRIX(r) adjuvant, has achieved immune responses
likely to be protective in 81% of recipient subjects with as little as 5ug of
antigen.
'The production and testingof a vaccine for a novel, lethal influenza virus in
such a short time period validates the agility of Novavax' technology in
addressing pandemic threats,' said Dr. Lou Fries, the company's Vice President
of Clinical and Medical Affairs. 'The performance of our vaccine candidate is
particularly important in light of the speed with which pandemic outbreaks can
unfold. Often, an initial outbreak of a novel influenza virus is followed by a
more severe and widespread outbreak at the onset of the next fall and winter
respiratory virus season, as seen in 2009 with H1N1. Unfortunately, vaccine
makers in 2009 were unable to produce vaccine in advance of the second wave and
there was little impact of vaccine upon H1N1 disease in the first year. Past
H7-based vaccine candidates have been poorly immunogenic and thus could not be
advanced as viable vaccine candidates. This risk appears to have been overcome
by our H7N9 adjuvanted VLP vaccine.'
Stanley C. Erck, President and Chief Executive Officer of Novavax, added, 'As
evidenced by our correspondence in The New England Journal of Medicine, this is
a critical accomplishment for pandemic preparedness. Building on the positive
clinical results with our H5N1 VLP vaccine candidate from last October, these
recently gathered data from our A(H7N9) influenza vaccine give further
confirmation that the Novavax vaccine platform deserves to play a key role in
addressing evolving pandemic threats. We have used recombinant VLP technology
to demonstrate that timely responses are possible, and we are proud to be the
first company to produce a viable H7N9 vaccine. Furthermore, we are pleased
that HHS-BARDA has recognized this achievement and asked us to focus our
pandemic vaccine development under our HHS-BARDA contract on our H7N9 vaccine
candidate.'
About H7N9 Avian Flu
Following recognition of the first human infections with avian-origin influenza
A(H7N9) and their attendant severity in March 2013, public health officials
from around the world called for immediate and preemptive development of
surveillance, diagnostic and clinical intervention tools in the event that the
A(H7N9) virus becomes transmissible among humans. According to Keiji Fukuda of
the WHO, there is high concern over potential for A(H7N9) to gain sustainable
person-to-person transmissibility. He noted that over a two-month period in
China, as many H7N9 cases occurred as caused by H5N1 cases over 10 years.
Additionally, molecular genetic changes occurred, suggesting adaptation of the
virus to humans. After a quiescent period during the summer months, four new
cases of human A(H7N9) disease have been reported since October 7, prompting
concerns and expectations over the virus reemerging in human populations in the
coming winter season.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company
creating novel vaccines and vaccine adjuvants to address a broad range of
infectious diseases worldwide. Using innovative proprietary recombinant protein
nanoparticle vaccine technology, the company produces vaccine candidates to
efficiently and effectively respond to both known and newly emergent diseases.
Novavax is involved in several international partnerships, including
collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea,
PATH and recently acquired Isconova AB, a leading vaccine adjuvant company
located in Sweden. Together, Novavax' network supports its global
commercialization strategy to create real and lasting change in the
biopharmaceutical and vaccinology fields. Additional information about Novavax
is available on the company's website, novavax.com.
About ISCOMATRIX(r) adjuvant
ISCOMATRIX(r) adjuvant is made from saponin, cholesterol and phospholipid which,
under defined conditions, form cage-like structures typically 40-50nm in
diameter. The optimized ISCOMATRIX(r) adjuvant is well defined, has minimal
impurities and does not use any materials of animal origin. Additionally,
improvements have been made to the manufacturing processes to ensure it can be
reproduced on a large scale. ISCOMATRIX(r) adjuvant is currently manufactured at
commercial scale at CSL's facility in Kankakee, Illinois.
Forward-Looking Statements
Statements herein relating to the future of Novavax and the ongoing development
of its vaccine and adjuvant products are forward-looking statements. Novavax
cautions that these forward looking statements are subject to numerous risks
and uncertainties, which could cause actual results to differ materially from
those expressed or implied by such statements. These risks and uncertainties
include those identified under the heading 'Risk Factors' in the Novavax Annual
Report on Form 10-K for the year ended December 31, 2012,and Form 10-Q for the
period ended June 30, 2013, both filed with the Securities and Exchange
Commission (SEC). We caution investors not to place considerable reliance on
the forward-looking statements contained in this press release. You are
encouraged to read our filings with the SEC, available at sec.gov, for a
discussion of these and other risks and uncertainties. The forward-looking
statements in this press release speak only as of the date of this document,
and we undertake no obligation to update or revise any of the statements. Our
business is subject to substantial risks and uncertainties, including those
referenced above. Investors, potential investors, and others should give
careful consideration to these risks and uncertainties
CONTACT: Barclay A. Phillips
Senior Vice President, Chief Financial Officer
Novavax, Inc.
240-268-2000
David Schull or Andrea Flynn, Ph.D.
Russo Partners, LLC
212-845-4271
David.schull(at)russopartnersllc.com
Andrea.flynn(at)russopartnersllc.com
News Source: NASDAQ OMX
13.11.2013 Dissemination of a Corporate News, transmitted by DGAP -
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Language: English
Company: Novavax, Inc.
United States
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