GAITHERSBURG, Md., June 7, 2017 /PRNewswire/ -- Novavax, Inc.,
(Nasdaq:NVAX) today announced that data from the second of two
Phase 2 trials of its RSV F protein recombinant nanoparticle
vaccine candidate (RSV F Vaccine) in women of child bearing age
have been published in the journal Vaccine (the data
contained in this publication have been shared in prior scientific
conferences). The Company previously announced top line results
from this trial in April 2014.
Novavax is developing the RSV F Vaccine with the goal of protecting
infants from RSV disease.
The manuscript describes the randomized, observer-blinded,
placebo-controlled dose-ranging trial which evaluated the safety
and immunogenicity of the RSV F Vaccine with and without varying
doses of aluminum-phosphate adjuvant. The trial enrolled 720 women
of child bearing age (18-35 years) at 10 clinical trial sites in
the United States who received
either one or two intramuscular injections of vaccine (at 60 or 120
µg doses) or placebo at study days 0 and 28.
The manuscript documents the significant antibody response
elicited by the RSV F Vaccine, including 11.6 to 12.7-fold
increases in anti-F IgG responses in women receiving a single dose
of 120 µg RSV F Vaccine with 0.2 or 0.4 mg of aluminum. These
antibody responses peaked 14 days post-vaccination and persisted at
significantly elevated levels for the 3 month period during which
immunogenicity was evaluated. Palivizumab-competing antibody (PCA)
levels were low or undetectable at day 0 but increased to 341-423
µg/mL on day 14 for the 120 µg 1-dose regimens. While baseline
levels of RSV/A and RSV/B microneutralizing titers did not vary in
the placebo group, they more than doubled at day 28 against both
RSV strains for the 120 µg, 0.4 mg aluminum formulation, which the
Company selected for further development.
Importantly, confirming results from the Company's prior trial
in a similar population, serologic evidence of a new RSV infection
by Western Blot was present in 21% (18/84) of placebo recipients,
compared to only 10% (36/352) of vaccinees, a 52% (p=0.009) overall
reduction of infection.
"The Western Blot finding from this trial, which demonstrates a
reduction in recent RSV infections of approximately 52% in the
vaccine relative to the placebo arms, is consistent with the
Western Blot data we reported from a comparable trial and
population in September of 2015. Together, these data suggest
that the RSV F Vaccine provided protection against RSV infection in
controlled trials of over 1,000 women," said Gregory Glenn, M.D., President, Research and
Development. "The results from this trial not only demonstrate
significant increases in anti-F IgG, PCA and microneutralizing
antibody titers in response to a 120 µg dose of the RSV F Vaccine
with 0.4 mg aluminum, the same dose and regimen used in our global
Phase 3 trial, Prepare, they are consistent with the immunogenicity
results reported in our prior trial in women of child bearing age.
While it was not the primary endpoint in the trial, the Western
Blot data suggest the potential to protect both the pregnant
mothers and their infants from RSV disease."
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biotechnology
company committed to delivering novel products to prevent a broad
range of infectious diseases. Our recombinant nanoparticles and
Matrix-M™ 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.
About Prepare™
Prepare is a global pivotal Phase 3 clinical trial of RSV F
Vaccine candidate for the protection of infants via maternal
immunization. The Prepare trial is a randomized, observer-blinded,
placebo-controlled trial in healthy pregnant women.
Participants are being vaccinated at a number of global
clinical sites in advance of each region's RSV season. Novavax
previously announced it was awarded a grant of up to $89 million from the Bill & Melinda Gates
Foundation to support development of this RSV F Vaccine, which
includes Prepare, product licensing efforts and World Health
Organization ("WHO") prequalification of our RSV F Vaccine.
About RSV
Respiratory syncytial virus (RSV) is the most common cause of
lower respiratory tract infections and the leading viral cause of
severe lower respiratory tract disease in infants and young
children worldwide, with estimated annual infection and mortality
rates of 64 million and 160,000, respectively.1 In the
US, RSV is the leading cause of hospitalization of infants, and
globally, is second only to malaria as a cause of death in children
under 1 year of age. 2,3 Despite the induction of
post-infection immunity, repeat infection and lifelong
susceptibility to RSV is common.4,5 Currently, there is
no approved RSV vaccine available.
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, 2016 and Report on
Form 10-Q for the period ended March 31,
2017 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:
Investor Relations
Novavax, Inc.
Andrea N. Flynn, Ph.D.
Director, Investor Relations
ir@novavax.com
240-268-2000
Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506
Media
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
212-845-4271
1 Nair, H., et al., (2010) Lancet.
375:1545 - 1555
2 Hall, C.B. et al. (2013) Pediatrics;
132(2):E341-348
3 Oxford Vaccine Group: http://www.ovg.ox.ac.uk/rsv
4 Glezen, W.P. et al. (1986) Am J Dis Child;
140:543-546
5 Glenn, G.M. et al. (2016) JID;
213(3):411-12
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SOURCE Novavax, Inc.