- Update on RSV F
Vaccine Phase 3 Prepare(TM) trial for
infants via maternal immunization
- Results from Phase 1/2 trial of
NanoFlu vaccine demonstrating improved immune responses compared to
egg-based, high-dose flu vaccine
GAITHERSBURG, Md., April 02, 2018
(GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today announced it
will present on its two lead vaccine programs at the World Vaccine
Congress, April 2-5 in Washington, D.C. These presentations include
details from the Phase 3 Prepare(TM) trial of its RSV F vaccine for
infants via maternal immunization, as well as positive results from
the Phase 1/2 trial of NanoFlu recombinant influenza vaccine,
including its proprietary Matrix-M(TM) adjuvant, in older
adults.
"We look forward to sharing this
meaningful information and data from our key vaccine clinical
trials with the international infectious disease community next
week at the World Vaccine Congress," said Stanley C. Erck,
President and CEO, Novavax, Inc. "Our RSV F and NanoFlu vaccines
both have strong potential to have significant impact on global
public health. We look forward to continuing the advancement of the
NanoFlu program and to completing the RSV Prepare trial and
preparing the BLA for this program."
Details for the two
presentations are as follows:
Title: "The
RSV F nanoparticle vaccine for infants via maternal immunization in
Phase 3: rationale and update"
Date and Time: Wednesday, April
4, 11:40 a.m.
Presenter: Gregory M. Glenn,
M.D., President of Research and Development, Novavax
Title: "Novavax NanoFlu vaccine induced
improved immune responses against homologous and drifted A/H3N2
viruses in older adults compared to egg-based, high-dose, influenza
vaccine"
Date and Time: Wednesday, April
4, 3:55 p.m.
Presenter: Vivek Shinde, M.D.,
Director of Clinical Development, Novavax
About
RSV
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.2 Despite
the induction of post-infection immunity, repeat infection and
lifelong susceptibility to RSV is common.3 Currently,
there is no approved RSV vaccine available.
RSV F
Vaccine Maternal Immunization Program
In December 2017, Novavax
completed a successful informational analysis of the Phase 3
Prepare(TM) clinical trial of its RSV F Vaccine for infants via
maternal immunization. The analysis of data from 1,307 infants in
the per-protocol population indicate an observed vaccine efficacy
in the range of between 45% and 100%. The Company anticipates that
it will reach approximately 4,600 participants, including
approximately 3,000 actively vaccinated mothers, in the second
quarter of 2018, which will enable an interim efficacy analysis
with results reported in early 2019. This program continues to be
funded under an $89 million grant from the Bill and Melinda Gates
Foundation (BMGF), and has been granted Fast Track designation by
the U.S. Food and Drug Administration (FDA).
About
Influenza
Influenza is a world-wide
infectious disease that causes illness in humans with symptoms
ranging from mild to life-threatening or even death. Serious
illness occurs not only in susceptible populations such as infants,
young children and older adults, but also in the general population
largely because of infection by continuously evolving strains of
influenza which can evade the existing protective antibodies in
humans. An estimated one million deaths each year are attributed to
influenza.4 Current
estimates for seasonal influenza vaccine growth in the top seven
markets (U.S., Japan, France, Germany, Italy, Spain and UK), show a
potential increase from approximately $3.2 billion in 2015 to $5.3
billion by 2025.5
Nanoflu Phase 1/2 Clinical
Trial
Novavax conducted a randomized, observer-blind,
comparator-controlled trial of NanoFlu vaccine (in two trivalent
formulations: 45µg or 180µg total HA) against IIV3-HD in 330
healthy adults aged 60 years or older. Immunogenicity was measured
by hemagglutination inhibition (HAI) and neutralization antibody
responses against a panel of vaccine-homologous, and historically
and forward-drifted, influenza virus strains.
About NanoFlu(TM) and Matrix
M(TM)
NanoFlu vaccine is a recombinant hemagglutinin
(HA) protein nanoparticle influenza vaccine candidate produced by
Novavax in its Sf9 insect cell baculovirus system. NanoFlu vaccine
uses HA amino acid protein sequences that are substantially the
same as the recommended strain HA sequences. NanoFlu vaccine
contains Novavax' patented saponin-based Matrix-M adjuvant, which
has demonstrated a potent and well-tolerated effect by stimulating
the entry of antigen-presenting cells into the injection site and
enhancing antigen presentation in local lymph nodes.
About
Novavax
Novavax, Inc. (Nasdaq:NVAX) is a
clinical-stage biotechnology company committed to delivering novel
products to prevent infectious diseases. Our RSV and influenza
nanoparticle vaccine candidates are Novavax' most advanced clinical
programs and are at the forefront of the Company's efforts to
improve global health. Additional information about Novavax is
available on the Company's website, novavax.com.
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, 2017 as 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:
Investors
Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506
Media
Sam Brown
Mike Beyer
mikebeyer@sambrown.com
312-961-2502
1 https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv
2 Leader
S. Pediatr Infect Dis J. 2002 Jul;21(7):629-32
3 PLOS.
"How immunity to respiratory syncytial virus develops in childhood,
deteriorates in adults." ScienceDaily. 21 April 2016.
https://www.sciencedaily.com/releases/2016/04/160421145747.htm
4 Resolution
of the World Health Assembly (2003) WHA56.19.28
5 Influenza
Vaccines Forecasts. Datamonitor (2013)