Novavax Announces Initiation of Ebola Vaccine Phase 1 Clinical Trial Supported by Non-Human Primate Challenge Data and Documented Rapid Manufacturing Capabilities
Initiation of Enrollment of Phase 1 Clinical Trial of Ebola GP Vaccine
Non-Human Primate Challenge Data Signal Breakthrough in
Ebola Vaccine Development
Rapid Manufacturing Process of Ebola GP Vaccine Published in
The Ebola GP Vaccine clinical trial, which is being conducted in
The Phase 1 clinical trial initiation is supported by significant immunogenicity and efficacy data demonstrating that the Ebola GP Vaccine is the first subunit Ebola GP-based vaccine to provide protection in non-human primates. Non-human primates received two injections of a 5µg dose of the Ebola GP Vaccine with the Matrix-M adjuvant, and were challenged with a lethal dose of Ebola virus. As expected, the challenge was lethal for the control animal whereas, in sharp contrast, 100% of the immunized animals were protected. Additionally, the Ebola GP Vaccine induced Ebola Makona strain GP antibody titers of 106 (ELISA EC90) after two doses and 104, after a single dose, both results well above the range reported to provide protection in non-human primate models and reported in recent Ebola Phase 1 clinical trials.
"The strong immune responses observed in our animal immunogenicity models and the protection observed in the non-human primate challenge models, confirm that our Ebola GP Vaccine is an important candidate for consideration. The use of a sequence reflecting the current circulating Makona strain of Ebola virus, along with the observed dose-sparing and enhanced antibody quality by the addition of our Matrix-M adjuvant, compelled the company to move to clinical testing," said
The rapid progression to a Phase I clinical trial is further supported by
Ebola virus, formerly known as Ebola hemorrhagic fever, is a severe, often fatal illness in humans. Five strains of Ebola virus have been identified, the most recent of which, the 2014 Makona strain, is associated with a case fatality rate of between 50 and 90%. There are currently no licensed immunological or therapeutic treatments proven to neutralize the virus, although a range of blood, immunological vaccine and drug therapies are under development.
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Barclay A. PhillipsSVP, Chief Financial Officer and Treasurer Novavax, Inc.240-268-2000 David Schullor Andrea Flynn, Ph. D. Russo Partners, LLC212-845-4271 David.email@example.com Andrea.firstname.lastname@example.org