Novavax Reports Positive Preclinical Results on its Novel Vaccine for Pandemic Influenza

MALVERN, Pa. -- Novavax, Inc., a specialty biopharmaceutical company, today reported preclinical results on the company's novel Virus-Like Particle (VLP) influenza

vaccine. Novavax's biological group, led by Dr. Gale Smith, together with Dr. Tumpey and Dr. Bu from the Centers for Disease Control and Prevention (CDC), published the detailed results in the Aug. 15, 2005 online edition of the journal Vaccine. The study demonstrates that a H9N2 influenza virus (avian flu) vaccine produced with the company's proprietary VLP technology is effective in protecting animals when challenged with live H9N2 influenza virus.

"Our VLP technology, based on a scalable process with short production lead times, offers an attractive alternative to the existing egg-dependent and the newer cell-based methods for the manufacture of influenza vaccine and other urgently needed vaccines. These advantages address the challenge of producing large quantities of a pandemic flu vaccine within a short timeframe," said Rahul Singhvi, president and CEO of Novavax. "This publication demonstrates the value of Novavax's VLP vaccine pipeline. Our plan is to advance our VLP technology into clinical trials with both pandemic and seasonal versions of influenza VLP vaccines."

The work was completed in collaboration with the CDC. It involved VLP vaccines constructed from proteins (HA, NA, and M1) produced from genes cloned from avian H9N2 influenza virus by Novavax at the CDC. The animals, vaccinated with a low dose of VLP without the addition of an adjuvant, developed antibodies after the first subcutaneous immunization. Immune responses increased after booster inoculation, and were shown to be protective when challenged with the H9N2 influenza virus.

"VLP vaccines depend on human immune mechanisms which are highly effective at recognizing and mounting a response against particles the general size and structure of viruses. The nanometer size and structural similarity of VLP vaccines to a live virus enable efficient interaction at a cellular level. VLP vaccines safely imitate whole virus vaccines and can never cause infection since they do not contain genetic material from a virus. Our VLP vaccines for flu, HIV/AIDS and other diseases are proving to be effective at stimulating immunity even at low doses and without the addition of chemical adjuvants," said Dr. Gale Smith, vice president of vaccine development at Novavax.

The study was supported in part by a grant from the National Institute of Allergy and Infectious Disease (NIAID) of the National Institutes of Health (NIH) to develop avian flu vaccines using VLP technology.

Source: Novavax, Inc.