Novavax Announces Positive Top-Line Data From RSV F Vaccine Phase 1 Clinical Trial in Pediatrics
September 29 2015 - 04:02PM
Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company
focused on the discovery, development and commercialization of
recombinant nanoparticle vaccines and adjuvants, today announced
positive top-line data from a Phase 1 clinical trial of its RSV
F-protein recombinant nanoparticle vaccine candidate (RSV F
Vaccine) in healthy children.
The trial was a randomized, observer-blinded,
Phase 1 study to evaluate the safety and immunogenicity of the RSV
F Vaccine, with one or two doses, with or without aluminum
phosphate adjuvant, in healthy pediatric participants two to six
years of age. The trial's primary goal was to evaluate safety in
this population and immunogenicity as measured by concentrations of
serum IgG antibodies to the RSV fusion, or F-protein,
palivizumab-competing antibody (PCA) titers and RSV
microneutralization titers. Novavax concluded this trial’s
enrollment with a smaller than planned cohort so dosing could be
completed ahead of the 2014-2015 RSV season.
Of the 32 total children enrolled, serum samples
were collected from a subset of 18 children in the per-protocol
population at 14, 28 and 56 days. All RSV F Vaccine formulations
and regimens were well-tolerated and highly immunogenic. Consistent
with prior trials, anti-F IgG and PCA titers increased rapidly at
day 14, peaked at day 28 and remained at elevated levels through
day 56; the last time point currently analyzed. There were greater
than 10-fold increases in both anti-F IgG and PCA antibody titers
in the adjuvanted group and greater than 6-fold increases in anti-F
IgG and PCA antibody titers in the unadjuvanted group.
“Given the seasonality of RSV and the fact that
infection could confound interpretation of the data, we closed out
the trial prior to the initiation of the RSV season. Despite the
small population, we were able to observe that the vaccine has the
potential to be both safe and immunogenic in young children,” said
Gregory Glenn, M.D., Senior Vice President, Research and
Development. “The strength of these data clearly support advancing
the RSV vaccine into a Phase 2 pediatric trial.”
“Our RSV F Vaccine has now elicited a robust
immune response in all three of our target populations: older
adults, infants via maternal immunization and pediatrics. We are
evaluating this data in the context of our RSV F Vaccine overall
clinical development program and look forward to providing an
update in the next several months on our path forward in the
pediatric population,” said Stanley C. Erck, President and CEO. “It
should not be lost on those interested in Novavax that this
announcement is the fifth positive clinical trial readout provided
during the third quarter of this year, a pivotal achievement for
the Company made possible by the power of our recombinant
nanoparticle platform technology and this dedicated and experienced
team.”
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, respectively1. In the
US, RSV is the leading cause of hospitalization of infants2.
Despite the induction of post-infection immunity, repeat infection
and lifelong susceptibility to RSV is common3,4. Currently, there
is no approved RSV vaccine available. Palivizumab is a monoclonal
antibody, licensed and sold by MedImmune as Synagis®, that targets
the RSV F protein and is used for prophylaxis against RSV disease
in high risk infants.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage
vaccine 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.
References:
1. Nair, H. et al.
Global burden of acute lower respiratory infections due to
respiratory syncytial virus in young children: a systematic review
and meta-analysis. Lancet, 2010; 375: 1545-1555.
2. Hall, C.B. et al. Respiratory
Syncytial Virus-Associated hospitalizations Among Children Less
Than 24 Months of Age. Pediatrics, 2013; 132(2): E341-348.
3. Glezen, W.P. et al. Risk of
primary infection and reinfection with respiratory syncytial virus.
Am J Dis Child, 1986; 140:543-546. 4.
Glenn GM, et al. Modeling maternal fetal RSV F vaccine induced
antibody transfer in guinea pigs. Vaccine, 2015; In press.
http://dx.doi.org/10.1016/j.vaccine.2015.08.039.
Contact:
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
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