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™ 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™ 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™ 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™ and Matrix M™
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:
InvestorsWestwicke PartnersJohn
Woolfordjohn.woolford@westwicke.com443-213-0506
MediaSam BrownMike Beyermikebeyer@sambrown.com312-961-2502
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)
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