- Phase 2 data in older adults (E205)
demonstrate adjuvants and 2-dose regimens significantly increase
the magnitude, duration and quality of the RSV F Vaccine immune
response
- New data demonstrate that Novavax'
construct is a stable prefusogenic RSV F antigen, distinctive from
other candidates, that elicits potent neutralizing antibody
responses to multiple key epitopes
- Path forward for a Phase 2 efficacy
trial in 2018 based on signal in COPD population identified in
prior older adult clinical trials
- Phase 3 Prepare(TM) trial
accelerating and now includes 80 sites across 11 countries allowing
continuous enrollment across global seasons
GAITHERSBURG, Md., July 24, 2017
(GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced
positive topline data from its Phase 2 safety and immunogenicity
trial of the RSV F Vaccine in older adults, new preclinical data on
its RSV F Vaccine construct, additional findings from the prior
Phase 2 and Phase 3 clinical trials in older adults (E201 and
E301), and an operational update on the Phase 3 clinical trial of
the RSV F Vaccine for infants via maternal immunization, known as
Prepare(TM). The Company anticipates initiating a Phase 2 efficacy
trial in older adults in 2018.
Topline data from the Phase 2
older adult safety and immunogenicity trial (E205) demonstrate the
benefit of adjuvant formulations and two-dose regimens. The
objective of the Phase 2 randomized, observer-blinded,
placebo-controlled trial was to assess safety and immunogenicity of
one and two-dose regimens of the RSV F Vaccine, with and without
aluminum phosphate or Novavax' proprietary Matrix-M(TM) adjuvant,
in 300 older adults. Participants were enrolled and
vaccinated outside of the RSV season to best assess immunogenicity
of the treatment arms. Immunogenicity outcomes indicate both
aluminum phosphate and Matrix-M adjuvants significantly increased
the magnitude, duration and quality of the immune response relative
to a control of 135 microgram dose of the RSV F antigen alone (the
formulation used in the prior Phase 3 older adults efficacy study).
Similarly, two-dose regimens significantly increased immune
responses and suggests two doses of the RSV F Vaccine with adjuvant
may augment durability of the immune response to the vaccine. The
data strongly support the inclusion of adjuvanted formulations of
the RSV F Vaccine in future older adult trials. All
formulations and regimens were safe and well-tolerated.
Recent scientific advances in
protein structure imaging and immune measures have led to new
insights about the structure and immune responses elicited by the
Novavax RSV F antigen. These new findings identify Novavax'
vaccine construct as a stable prefusogenic RSV F protein
nanoparticle. In addition, new analyses have confirmed and
expanded the data, demonstrating that the vaccine induces a
repertoire of broadly neutralizing RSV F antibodies in humans that
are more potent than palivizumab (Synagis®). These new structural
and immunological analyses validate the RSV F Vaccine as a highly
immunogenic antigen with the potential to provide protection
against RSV disease.
Older adult Phase 3 trial data in
a recent post-hoc analysis indicate the RSV F Vaccine was
associated with a 61% reduction in hospitalizations due to chronic
obstructive pulmonary disease (COPD) exacerbations. Review of the
E201 database showed a similar signal supporting this finding. COPD
exacerbations represent an unmet medical need and a significant
healthcare cost burden. Novavax plans to initiate a Phase 2
efficacy trial in older adults in 2018, that will evaluate COPD
exacerbations as a prospective endpoint.
Prepare, the Phase 3 trial of the
RSV F Vaccine for infants via maternal immunization, conducted in
collaboration with the Bill and Melinda Gates Foundation, continues
its momentum into the third global season of enrollment. Prepare's
global footprint has grown from 16 sites in five countries in its
first global RSV season of enrollment to 80 sites in 11 countries.
The clinical trial infrastructure and experience developed over the
last two seasons establish the foundation to efficiently enroll and
execute this first of its kind global maternal immunization
clinical trial.
"Since September, we have worked
to confirm that our RSV F Vaccine elicits a broadly neutralizing
antibody response. Through our E205 trial, we have demonstrated
adjuvant strategies that magnify and enrich the quality of that
underlying antibody response. When combined with the COPD data seen
in both E301 and E201, we believe protecting individuals from COPD
exacerbation presents a very exciting path forward in older
adults," said Gregory Glenn, M.D., President of R&D.
"The new data that further
characterizes the RSV F Vaccine and the benefit of adjuvants,
combined with the hospitalization data in the COPD population,
places us in a strong position to partner our RSV program," said
Stanley C. Erck, President and CEO. "We also look forward to
continued momentum in Prepare trial enrollment and to developing
our plans for the next steps in our RSV older adult program over
the next 12 months."
Conference
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Monday, July 24, 2017 |
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4:30 p.m. U.S. Eastern Time
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(877) 212-6076
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54820069 |
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Conference call and webcast
replay:
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Starting at 7:30 p.m. ET, July
24, 2017, until 7:30 p.m. ET, October 24, 2017 |
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(855) 859-2056 (Domestic) or
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54820069 |
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www.novavax.com, "Investors"/
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About
Prepare(TM)
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.
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. Its
recombinant nanoparticles and Matrix-M(TM) adjuvant technology are
the foundation for groundbreaking innovation that improves global
health through safe and effective vaccines.
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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