Novavax Shares Edge Higher as the New England Journal of Medicine Has Published Data on Co.'s Bird Flu Vaccine

Novavax, Inc.

today announced that positive clinical data for the company's virus-like particle (VLP) vaccine candidate against A(H7N9) influenza were published online in the Correspondence section of The New England Journal of Medicine. The correspondence can be found at: http://www.nejm.org/doi/full/10.1056/NEJMc1313186 and will appear in the December 26, 2013 print edition. The study, conducted in 284 adult male and female subjects, examined the safety and immunogenicity of two administrations of Novavax' A(H7N9) VLP vaccine candidate on day 0 and day 21. Subjects were administered either placebo, 15 or 45 µg of vaccine alone, or 5 or 15µg of vaccine with either 30 or 60 ISCO^® units of the saponin-based ISCOMATRIX^® adjuvant, developed by CSL Limited in Australia. Serology was assessed at Days 0, 21 and 35 post-first immunization. The Novavax A(H7N9) VLP vaccine candidate was generally well tolerated, and the safety was in line with the company's previous findings with its influenza VLP antigens using ISCOMATRIX^® adjuvant. Overall, as with other adjuvanted influenza vaccines, there was an increase in transient local and systemic reactions in the adjuvanted in contrast to the non-adjuvanted formulations, but there were no treatment-related SAEs in the active groups. The A(H7N9) VLP vaccine candidate induced hemagglutination-inhibition (HAI) antibody titers of ≥1:40 (seroprotection) and a four-fold HAI antibody rise (serconversion) against H7N9 in 81% of subjects at the 5mg dose of A(H7N9) antigen with 60 ISCO^® units of adjuvant, and 73% of subjects receiving 5mg dose of A(H7N9) antigen with either adjuvant dose level. The vaccine also elicited anti-neuraminidase (NA) antibodies against N9 in 92 to 97% of subjects receiving 5mg with either adjuvant dose level. The A(H7N9) influenza strain has emerged recently as a potential pandemic concern. Less than ten (10) days after the Chinese Health authorities announced an outbreak of this novel avian influenza in humans (137 total confirmed cases, including 45 deaths, to date), Novavax obtained the genetic sequence of the strain and commenced production of a recombinant vaccine. Clinical trial material was manufactured and released in late June 2013 with the first doses injected in humans in early July 2013. Less than four months after the novel A(H7N9) virus had been identified and sequenced, Novavax' H7N9 VLP vaccine, with the higher-dose of ISCOMATRIX® adjuvant, has achieved immune responses likely to be protective in 81% of recipient subjects with as little as 5µg of antigen.