Novavax Commences Clinical Testing of its Seasonal Influenza VLP Vaccine... (e virus; NA induces antibodies that prev...)

Novavax Commences Clinical Testing of its Seasonal Influenza VLP Vaccine Candidate

Date:9/16/2008

e virus; NA induces antibodies that prevent cell-to-cell transmission of virus down the respiratory tract, potentially reducing the severity of influenza disease; and cell mediated immune responses to M1 may lead to destruction of cells already infected. Further, the vaccine is made in cell culture rather than eggs, which permits an exact genetic match to the flu strains causing illness since there is no requirement for adapting the vaccine to grow in eggs.

"We are delighted to initiate our seasonal influenza vaccine program in Phase II human trials," said Dr. Rahul Singhvi, President and CEO of Novavax. "VLPs are a very promising approach against influenza as we recently demonstrated with the announcement of favorable results in a Phase IIa human clinical trial of our VLP based pandemic influenza vaccine. There are synergies to be gained in the development of our VLP pandemic and seasonal influenza vaccines that provide the Company unique advantages. For example, since both vaccines utilize the same manufacturing approach, safety information from either one of these influenza vaccine programs would compliment and support the other program which should reduce the overall development timeline for each program."

Novavax's novel manufacturing approach

Novavax's manufacturing process makes it possible to rapidly produce a vaccine that contains strains that are an exact genetic match to the strains circulating in the community causing influenza disease. Novavax's influenza VLPs are produced through recombinant technology in insect cell culture, utilizing a manufacturing process that will consist entirely of disposable, ready-to-use equipment. Current yields are 7 to 10 times higher than those of traditional egg-based or mammalian cell culture manufacturing. Because the Novavax process involves recombinant technology and does not require a live influenza virus, a matched vaccine for the first seasonal influenza clinical trial was manufactured within 1
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Novavax Commences Clinical Testing of its Seasonal Influenza VLP Vaccine...(e virus; NA induces antibodies that prev...)