Full Press Release Details
SVP, Chief Financial Officer and
Announces Positive Top-Line Results from Phase 1 Clinical Trial of
RSV Vaccine Candidate in Elderly
Rockville, MD (July 2, 2013)-/GlobeNewswire,
Inc. /-Novavax, Inc. (NASDAQ: NVAX) today announced positive top-line safety and immunogenicity data for its respiratory syncytial
virus (RSV) vaccine candidate from a dose-ranging Phase 1 study in elderly adults. All subject groups receiving the recombinant
fusion (F) protein nanoparticle vaccine candidate exhibited antibody responses against RSV at 28 and 56 days post-immunization,
with rises in serum anti-F immunoglobulin G (IgG) antibody levels. The highest response rates and greatest increases in antibody
levels were observed in groups receiving RSV F antigen with aluminum phosphate as an adjuvant. All subjects simultaneously received
a licensed seasonal trivalent influenza vaccine to ensure coverage over the influenza season. Local and systemic safety were monitored
and together with the interim immunogenicity are provided here as top line data through Day 56.
The study examined the immunogenicity and
safety of Novavax's RSV F nanoparticle vaccine in 220 healthy elderly adults ( 60 years of age, mean age of 68 years of
age). Subjects received either 60 g or 90 g of the RSV F vaccine candidate, with or without adjuvant, or a placebo.
The vaccine was well tolerated with no meaningful differences in the frequencies of adverse events (AEs) between the placebo (70%)
and active vaccine groups (58-75%), and no dose-related trends in AEs. The adjuvant groups had a higher incidence rate of injection
site AEs (43%) compared to placebo (23%), but all such AEs were reported as mild or moderate in severity. There were no vaccine-related
serious AEs, and no subject withdrawals due to AEs.
Highlights of the interim immunogenicity
results of the RSV F vaccine in elderly adults include:
data provide further evidence that our RSV F nanoparticle vaccine is well-tolerated and immunogenic," said Gregory Glenn,
Chief Medical Officer of Novavax. "As seen in our previous trials in younger subjects, the vaccine induced an important
functional immune response in the palivizumab-like antibodies, as well as enhancing microneutralization antibodies to levels that
are in excess of the range expected to reduce hospitalizations resulting from RSV. In addition, the co-administration of
the RSV F vaccine candidate with a licensed seasonal influenza vaccine did not appear to negatively impact or interfere with induction
of immunity in the influenza vaccine."
"Protecting the elderly from respiratory
ailments is an important part of both our RSV and our seasonal influenza vaccine development programs," noted Stan Erck,
President and CEO of Novavax. "These data suggest a path forward for a Novavax combination RSV and seasonal influenza vaccine
to improve the coverage for respiratory infections in elderly and high-risk adults."
respiratory pathogen in infants, children, and adults. RSV infections in adults represent re-infections and are generally mild
to moderate in severity, except in persons with high-risk conditions including the elderly and adults with underlying chronic cardiac
or pulmonary disease. It is estimated that between 11-17,000 adults die of RSV infection annually in the U.S., with and up to 180,000
admitted to hospital with respiratory symptoms. Currently, there is no approved RSV prophylactic vaccine available.
About VLPs and Novavax' Vaccine
VLPs are self-assembling protein structures
that resemble the external structure of viruses, elicit broad and strong antibody and cellular immune responses but lack the live
genetic material that causes viral replication and infection. VLPs contain three of the major structural virus proteins that are
important for fighting influenza: hemagglutinin and neuraminidase, both of which stimulate the body to produce antibodies that
neutralize the influenza virus and prevent its spread through the cells in the respiratory tract, and matrix 1, which stimulates
cytotoxic T lymphocytes to kill cells that may already be infected. VLPs can be designed quickly to match individual viral strains
and be produced efficiently using portable recombinant cell-culture technology. Novavax' VLP-based vaccine candidates are
produced more rapidly than egg-based vaccines because of our cell-culture technology platform combined with single-use bioprocessing
technology employed strategically throughout the manufacturing process.
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage
biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant
nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat
diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections.
Novavax is committed to using its technology platform to create geographic-specific vaccine solutions and is therefore involved
in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea
and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have the global reach to
create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's
website, www.novavax.com.
Forward-Looking Statements
Statements herein relating to the future
of Novavax and Novavax's vaccine 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 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 www.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.