CRANBURY, NJ, May 18, 2009

What is VaxInnate doing to address the Swine Flu (H1N1 influenza A) outbreak?

VaxInnate has responded rapidly to develop a recombinant H1 Swine Flu Vaccine that could be available for animal testing by mid-June, in as little as 6 weeks. 

If preclinical testing is successful, the first doses of VaxInnate’s candidate Swine Flu Vaccine could be available within 12 weeks and enough vaccine to meet national needs could be manufactured using a bacterial fermentation process in a time frame of weeks instead of months.  No technology in use today or in development is faster.   

In addition, VaxInnate is also planning to evaluate our existing M2e Universal Flu Vaccine Candidate for activity against Swine Flu once we receive the M2e sequence of the swine flu we’ve requested from the Centers for Disease Control (CDC) and National Institutes of Health (NIH).  Our Universal Flu Vaccine Candidate has already completed Phase I safety and immunogenicity studies and is on track to begin Phase II studies this year.

Why are you so confident that you can develop a Swine Flu Vaccine in six weeks -- faster than other companies, including the highly experienced commercial influenza vaccine producers?

VaxInnate has already developed a candidate vaccine against another H1 flu strain – the circulating Swine Flu is an H1 strain -- going from antigen sequence to animal testing in just six weeks.  

We reported positive clinical data on that H1 seasonal flu vaccine candidate at the National Institute for Infectious Diseases’ (NFID) vaccine meeting in late April, coincidentally the same week that Swine Flu was declared a pandemic.  Those data showed that the candidate vaccine was highly potent at just one-tenth of the standard human dose for flu vaccines, as well as safe.

In addition, VaxInnate’s management and scientific team is composed of individuals with decades of collective experience in vaccine discovery and development, much of it at big pharmaceutical vaccine makers.  Their efforts led to many of the vaccines that are in wide use today.  These dedicated and highly experienced people are now focusing their efforts on speeding development of a Swine Flu Vaccine.

Why would VaxInnate’s prototype Swine Flu Vaccine be easier and faster to produce than vaccines made using eggs or cells? 

VaxInnate’s proprietary technology is based on a combination of toll-like receptor (TLR)-mediated immune enhancement and recombinant bacterial production of vaccine antigen. VaxInnate’s vaccines are pure, soluble proteins that require no adjuvants and are produced in E. coli bacteria, meaning that millions of vaccine doses can be manufactured in a time frame of weeks instead of months. 

In addition, due to its transferability and efficiency, vaccine could be produced regionally and manufactured at low cost using existing biotechnology facilities with microbial production capacity.  This enables us to rapidly address the needs of an emerging pandemic without impacting the supply of seasonal flu vaccine.

Comparatively, making flu vaccine using eggs is a laborious process that takes as long as 9 months and requires large, centralized manufacturing facilities.  Federally funded alternatives in development, such as cell-based production, take about 6 months, but that’s still too long. 

History has shown that pandemic flu spreads rapidly through the human population.  Time measured in months – the time it would take to produce flu vaccine using eggs or cells -- potentially translates into widespread illness, lost lives, and a further weakened global economy. 

Is VaxInnate working with U.S. health authorities on development of a Swine Flu Vaccine?

VaxInnate has been in close and frequent contact with the Office of Emergency Preparedness at the Centers for Disease Control (CDC).  We have obtained the necessary H1N1 influenza A virus stock, and we anticipate the convalescent antisera necessary for qualifying our proteins.  The Influenza Branch of the CDC is also aware of our ongoing efforts to develop a swine flu vaccine prototype, as is the National Institutes of Health (NIH).

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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Contact:          

Janet Skidmore

Office:  215-658-4915

Mobile:  215-429-2917

skidmorecomm@earthlink.net 

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