Novavax, Inc. today announced that Gale Smith, Ph.D., Vice President of Vaccine Development at Novavax, presented at the 8th Vaccine and ISV Conference in Philadelphia on Sunday, October 26. Dr. Smith's presentation was titled: 2014 Guinea Ebola Virus Recombinant Glycoprotein (GP) Nanoparticle Vaccine was Highly Immunogenic and Cross-Neutralized 1976 Virus GP Pseudovirus.
Dr. Smith reported on Novavax' Ebola GP recombinant nanoparticle vaccine candidate (EBOV GP Vaccine), which is based on the 2014 Guinea Ebola strain that is responsible for the current Ebola disease epidemic in West Africa. In preclinical models, the EBOV GP Vaccine induced antibody titers against the homologous 2014 Guinea Ebola GP in the range of 103 to 104 (ELISA EC 90). Aluminum phosphate as an adjuvant resulted in a modest adjuvant effect; however, the Company's proprietary adjuvant Matrix-M™ enhanced anti-Ebola GP responses by 10 to 100 fold, inducing Ebola GP antibody titers of 105 to 106 (ELISA EC90). Importantly, EBOV GP vaccine plus Matrix-M induced serum cross-neutralization to the older Ebola 1976 (Mayinga) GP-VSV pseudotype. The EBOV GP Vaccine, adjuvanted with Novavax' Matrix-M adjuvant, induced anti-GP ELISA and neutralizing antibody levels well within ranges reported to protect against Ebola viruses in rodent and non-human primate models.
"We are developing our recombinant Ebola GP vaccine using the same platform we used to develop vaccine candidates against several pathogens including respiratory syncytial virus (RSV), seasonal and pandemic influenza, and Middle Eastern Respiratory Syndrome (MERS)," said Stanley C. Erck, President and CEO. "Our proprietary platform allows us to quickly develop, and manufacture an Ebola vaccine candidate at large scale, which we believe can provide a necessary tool to fight this global health crisis."
Novavax has recently initiated a non-human primate study and expects to initiate a Phase 1 clinical trial in December 2014 to evaluate the safety and immunogenicity of the EBOV GP Vaccine in ascending doses, with and without the Matrix-M adjuvant, in approximately 150 subjects. Plans to demonstrate the safety and efficacy in a large-scale global clinical trial will be developed based on data from the Phase 1 trial and in collaboration with global regulatory authorities and world health agencies.
"We used the recently published Guinea 2014 Ebola strain genetic sequence to create a highly purified, correctly folded, Ebola GP Vaccine in only a few weeks," said Gregory Glenn, M.D., SVP, Research and Development at Novavax. "The data presented today provides scientific validation that our technology platform can respond to emerging viral threats in an extremely efficient and effective manner. We look forward to the results of our non-human primate study and the initiation of a Phase 1 clinical trial in the near future."