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VaxInnate Awarded NIH Funding for Collaborative Dengue Fever Vaccine Development

-- Award based on TLR technology platform’s application in developing vaccines for Flavivirus and other infectious diseases --

Media Inquiries Krystle Ficco Feinstein Kean Healthcare 617-761-6702 Krystle.Ficco@fkhealth.com

Cranbury, NJ, July 23, 2007 – VaxInnate announced today that it has been awarded a 2-year, $597,000 Small Business Innovation Research (SBIR) grant from the National Institutes of Health to support the development of a tetravalent Dengue virus vaccine in collaboration with scientists at the University of Texas Medical Branch at Galveston (UTMB). This SBIR grant award is the result of proof of principle studies completed in a West Nile Virus (WNV) collaboration and recently published in the Journal of Infectious Diseases.

“This grant is yet another significant milestone for VaxInnate, as our technology continues to demonstrate wide-reaching applicability across disease indications in addition to our lead program in influenza vaccines,” said Alan Shaw, President and Chief Executive Officer of VaxInnate. “Strong financial support, such as the grant we have received from the NIH, ensures that we are able to continue to develop vaccine programs that will meet global health needs in a very practical and effective way.”

“In the past, researchers have faced difficulties in developing a vaccine for Dengue virus, given the four different serotypes of the virus,” added Dr. William McDonald, Group Leader of Biochemistry at VaxInnate and Principal Investigator on the grant award. “Protection against one serotype may render the host more susceptible to subsequent infection by another serotype, a situation which may lead to life-threatening Dengue Hemorrhagic Fever. Thus, it is imperative that a vaccine induce protection against all four serotypes of Dengue virus.”

According to the Centers for Disease Control and Prevention (CDC), Dengue Fever is the most important mosquito-borne viral disease affecting humans. Dengue virus geographic distribution is similar to that of malaria, and an estimated 2.5 billion people live in areas at risk for epidemic transmission. Currently, there is no available vaccine for Dengue virus infection. People living in Dengue-endemic areas can have more than one dengue infection during their lifetime. Dengue Fever can result in a wide range of symptoms and illnesses ranging from a nonspecific viral syndrome to severe and fatal hemorrhagic disease.

"Dengue fever is the largest cause of hemorrhagic fever in many geographic regions, including the Asia Pacific region and South America. The need to develop a tetravalent vaccine that induces protective immunity simultaneously against the four dengue serotypes has made it quite difficult with currently used technologies to develop an effective vaccine," said David Beasley, Principal Investigator at the University of Texas Medical Branch.

Jeff Powell, Vice President of Research at VaxInnate, added, “The proof of concept studies in the West Nile virus model confirm that our TLR technology has applications in a number of Flavivirus diseases, including Dengue. This funding enables us to utilize this technology to formulate the correct ratio of the different serotypes of Dengue virus proteins to develop a tetravalent vaccine that is effective in controlling a disease that has plagued various parts of the world for decades.”

The SBIR grant will be used to support additional pre-clinical research on a Dengue virus vaccine based on the company’s TLR platform, as applied to known Dengue virus antigens. VaxInnate’s TLR technology platform links vaccine antigen to bacterial flagellin, a component of the long hair-like tails that help bacteria swim and an example of a molecular pattern recognized by TLRs. The vaccines are extremely immunogenic, triggering an innate immune response through the interaction of flagellin with TLR5, which then stimulates a vigorous adaptive immune response to the linked antigen. The method produces robust immune responses in animal models of human and avian influenza virus, West Nile virus, Japanese encephalitis virus, malaria, and other diseases. In addition, recombinant expression of flagellin fusion proteins in standard microbial fermentation platforms allows for large-scale, rapid and efficient vaccine production.

About VaxInnate

VaxInnate is a privately-held biotechnology company focused on developing novel, proprietary vaccines for both pandemic and seasonal influenza. The company's Toll-like receptor (TLR) technology platform allows for genetic engineering of the vaccines using recombinant DNA techniques. This technology physically links TLR agonists to vaccine antigens, which allows the conjugated vaccine to trigger an adaptive immune response. VaxInnate is using its TLR platform technology to enhance the immunogenicity of a series of antigens which will be combined into a number of different influenza products. The technology platform is also being investigated for development of vaccines for other diseases. For more information on VaxInnate, please visit http://www.vaxinnate.com.

The project described was supported by Grant Number R43AI074612 from the National Institute of Allergy and Infectious Diseases. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health.