CRANBURY, NJ, June 17, 2009

WASHINGTON, D.C., June 17, 2009 – VaxInnate Corporation today reported positive preclinical results for a recombinant swine flu vaccine it developed in less than three weeks, making it one of the first companies in the world to begin testing a vaccine that could help halt the spread of the swine flu pandemic. 

Preclinical studies in mice suggest that VaxInnate’s recombinant swine flu vaccine could provide protection against the pandemic H1N1 influenza A swine flu strain, VaxInnate CEO Alan Shaw, PhD told attendees at the 7th Annual Biodefense Vaccines and Therapeutics meeting taking place here.  Further preclinical testing of the vaccine is already underway.

“Using our novel vaccine technology, VaxInnate was able to rapidly develop and begin testing a vaccine that could be a useful weapon against the pandemic flu,” Dr. Shaw said. “We’re encouraged by our results to date and are moving forward with further preclinical testing. 

“In doing so, VaxInnate is hoping to partner with the U.S. government on further development of our swine flu vaccine,” he added. “The federally-funded vaccine technologies in development cannot produce vaccines as rapidly and efficiently as VaxInnate can, and we want the opportunity to demonstrate our capabilities.”

Dr. Shaw said VaxInnate is also seeking international partners for the development of this and other pandemic vaccines to meet global needs.  VaxInnate’s announcement comes less than a week after the World Health Organization (WHO) declared the first flu pandemic in 41 years.

Promising Results and Technology

VaxInnate’s swine flu vaccine elicited hemagglutinin (HA)-inhibiting antibody in mouse studies at levels that are generally considered to be protective.  HA is the key protective component used in flu vaccines for many years. Results were similar to those seen with VAX 125, VaxInnate’s HA-flagellin vaccine for seasonal flu that generated positive Phase I clinical results.  

The swine flu vaccine was produced using VaxInnate’s proprietary combination of toll-like receptor-mediated (TLR) immune enhancement and recombinant bacterial production of vaccine antigen. 

VaxInnate’s swine flu vaccine genetically fuses the protective subunit of the HA molecule to the TLR agonist, flagellin.  Flagellin is a bacterial protein that interacts with the immune system’s TLRs to enhance immunological potency.  The proprietary recombinant protein vaccine is produced in bacteria and triggers TLR-mediated enhancement of the immune response. 

The ability to produce a recombinant vaccine in a bacterial expression system means that VaxInnate’s technology has significant speed and volume advantages, enabling production of many millions of vaccine doses -- sufficient to protect all 300 million Americans, for example -- in a time frame of weeks instead of months.

The vaccine must undergo review and licensure by the U.S. Food and Drug Administration (FDA) before it could become available in the United States. Similarly, regulatory agencies in other countries or regions must license the vaccine before it can be used in those areas.

Conventional means of making flu vaccines using eggs takes 6-9 months. While the federal government is funding alternative cell-based production, vaccine production using cell culture takes about six months compared to the weeks it takes using VaxInnate’s technology.

In addition, due to its transferability and efficiency, dedicated new vaccine factories would not be needed with VaxInnate’s technology. Instead, vaccine could be produced in regional international facilities and manufactured using existing biotechnology facilities with microbial production capacity. 

In addition to developing its swine flu vaccine, VaxInnate hopes to evaluate the use of its existing M2e universal vaccine candidate against the emerging swine flu.  This vaccine has completed Phase I human studies and is slated to enter Phase II human studies this year.

About VaxInnate

VaxInnate is a privately-held biotechnology company in Cranbury, NJ that is pioneering breakthrough technology for use in developing novel and proprietary vaccines.  VaxInnate’s technology has the potential to dramatically improve the potency, manufacturing capacity and cost-effectiveness of vaccines. 

VaxInnate’s first vaccines focus on infectious diseases, including seasonal and pandemic flu, malaria, dengue, human papillomavirus and respiratory syncytial virus.  In 2008 and 2009, VaxInnate generated positive Phase I clinical data for its first two vaccines, a universal flu vaccine and a seasonal flu vaccine.  For more information about VaxInnate, please visit http://www.vaxinnate.com.

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Janet Skidmore

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