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2015-09-15

Novavax, Inc.: Novavax RSV F Vaccine is Highly Immunogenic With Robust Transplacental Antibody Transfer in Preclinical Maternal Immunization Model

GAITHERSBURG, Md., Sept. 15, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc.,
(Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery,
development and commercialization of recombinant nanoparticle vaccines and
adjuvants, today announced its RSV F-protein recombinant nanoparticle vaccine
candidate (RSV F Vaccine) was shown to be highly immunogenic in a guinea pig
model of maternal immunization. The preclinical study was published in the
journalVaccine
.1

Direct immunization of infants is complicated by their immature immune systems
which are unable to fight off viral infection early in life when infants are
most vulnerable to RSV. In mammals, the passage of maternal antibodies to
offspring is largely achieved either byin utero
transplacental transfer of immunoglobulin G antibodies (IgG) or by postpartum
breast-feeding of colostral milk containing high levels of IgG and sIgA.2For
human infants, maternally-derived IgG appears to be provided entirelyin utero
, via transplacental Fc receptor-mediated antibody transfer.2The protective
effects of human serum IgG, transferred from mothers to infants in
utero,2against a number of infections, including influenza and pertussis, has
been well-described.3-5

Presumptive pregnant guinea pigs were immunized with the RSV F Vaccine on
gestational days 25 and 46. The vaccine induced high levels of anti-F IgG
antibodies, palivizumab-competing antibodies (PCA) and microneutralizing
titers. The peer-reviewed manuscript also demonstrates transfer of placental
anti-RSV antibodies, as measured by a number of immunoassays, at days 15 and
30 postpartum.

"RSV is the leading cause of infant hospitalizations in the U.S. and a
significant unmet need in full-term infants," said Gregory M. Glenn, M.D.,
Senior Vice President, Research and Development at Novavax. "The placental
architecture in guinea pigs reflects the anatomy found in humans, making them
an appropriate model to evaluate placental transfer of antibodies. These
preclinical data further support our RSV F Vaccine maternal immunization
program, and we look forward to announcing data from our Phase 2 clinical
trial to protect infants via maternal immunization this quarter."

Copies of this paper are available to credentialed journalists upon request;
please contact Elsevier's Newsroom atnewsroom@elsevier.comor +31 20 4853564.

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.6In the US, RSV is responsible for approximately 57,000
hospitalizations of children under five years of age annually, the vast
majority of which occur in infants less than one year old, and especially
those under six months of age.7-11Despite the induction of post-infectious
immunity, repeat infection and lifelong susceptibility is common.12Currently,
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 Vaccine

Vaccine is the pre-eminent journal for those interested in vaccines and
vaccination. It is the official journal of The Edward Jenner Society, The
International Society for Vaccines and The Japanese Society for Vaccinology
and is published by Elsevier.www.elsevier.com/locate/vaccine

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(TM) 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 "Modeling Maternal Fetal RSV F Vaccine Induced Antibody Transfer in Guinea
Pigs," by Gregory M. Glenn, Louis F. Fries, Gale Smith, Eloi Kpamegan,
Hanxin Lu, Mimi Guebre-Xabier, Somia P. Hickman, and David Flyer.
DOI:10.1016/j.vaccine.2015.08.039. It appears inVaccine , In Press, 2015,
published by Elsevier.
2 "Comparative placental structure," by A.C. Enders, T.N. Blankenship.Adv
Drug Delivery Rev , 38 (1999), pp. 3-15.
3 "The protective role of maternally derived antibodies against Bordetella
pertussis in young infants," by U. Heininger et al.Pediatr Infect Dis J ,
32 (2013), pp. 695-698.
4 "Influenza vaccination of pregnant women and protection of their infants,"
by S.A. Madhiet al. N Engl J Med , 371 (2014), p. 2340.
5 "Neonatal outcomes after influenza immunization during pregnancy: a
randomized controlled trial." by M.C. Steinhoffet al. CMAJ 184 (2012), pp.
645-653.
6 "Global burden of acute lower respiratory infections due to respiratory
syncytial virus in young children: a systematic review and meta-analysis,"
by Nair, H.et al. Lancet , 2010; 375: 1545-1555.
7 "Respiratory syncytial virus-associated hospitalizations among infants and
young children in the United States, 1997-2006," by L.J. Stockmanet al.
Pediatr Infect Dis J , 2012; 31:5-9.
8 Centers for Disease Control and Prevention, update May 5, 2015. Respiratory
Syncytial Virus Infection. Trends and
Surveillance.http://www.cdc.gov/rsv/research/us-surveillance.html
9 "Rates of hospitalization for respiratory syncytial virus infection among
children in Medicaid," by T.G. Boyceet al. J Pediatr , 2000; 137:865-870.
10 "The Burden of Respiratory Syncytial Virus Infection in Young Children," by
C.B. Hall Hallet al. N Engl J Med , 2009; 360(6): 588-98.
11 "Respiratory Syncytial Virus-Associated hospitalizations Among Children
Less Than 24 Months of Age." by C.B. Hallet al. Pediatrics , 2013; 132(2):
E341-348.
12 "Risk of primary infection and reinfection with respiratory syncytial
virus," by W.P. Glezenet al. Am J Dis Child , 1986; 140:543-546.

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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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novavax, Inc. via Globenewswire

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