PRESS RELEASE: VaxInnate Initiates Phase I Clinical Study of M2e Universal Influenza Vaccine

VaxInnate Initiates Phase I Clinical Study of M2e Universal Influenza Vaccine

Company’s First Clinical Trial Studies Vaccine Based on New Vaccine Technology

Cranbury, NJ, September 25, 2007 – VaxInnate Corporation announced today that it has commenced its first Phase 1 clinical trial, testing its M2e universal influenza vaccine. The universal vaccine is designed to target the M2 ectodomain (M2e) portion of the flu virus, which is inherent regardless of virus strain. The study will provide investigators with important information on the vaccine’s safety and immunogenicity, a patient’s ability to generate an immune response. The study will also provide important information on VaxInnate’s toll like receptor (TLR) technology utilizing flagellin, which helps to strengthen the body’s immune response by triggering both of the major arms of immune defense – innate (non-specific) and adaptive (specific).

"This study represents an important milestone for VaxInnate – the launch of our first clinical trial," said Alan Shaw, chief executive officer of VaxInnate. “The M2e universal vaccine is designed to elicit a more potent response from the immune system, delivering a one-two punch by stimulating the innate immune response with flagellin, which in turn enhances an adaptive, antibody response against M2e. This strategy is particularly useful when targeting regions of the virus like M2e, which are conserved in all influenza strains.”

Shaw continued, "This study is part of a comprehensive influenza vaccine development program designed to develop recombinant hemagglutinin and M2e-based seasonal and pandemic influenza vaccines, utilizing a Toll-Like Receptor agonist, flagellin, and based on our already proven manufacturing technology. We anticipate beginning a clinical trial for our hemagglutinin-based seasonal and pandemic influenza vaccines in 2008.”

The M2e clinical trial is scheduled to enroll 60 volunteers in a double-blind, dose-escalating study of two doses injected 28 days apart. The placebo-controlled study is designed to assess the safety and immunogenicity of two doses of vaccine in healthy young adults in dosages of 10, 33, and 100 ug. Data are expected for this trial in spring 2008.

“We believe VaxInnate’s approach to vaccine development has the potential to provide developing countries and regions with influenza vaccines that are less expensive and more effective than currently available alternatives,” said the principal investigator for the grant, Professor Lawrence R. Stanberry, chairman of the UTMB Department of Pediatrics and director of the Sealy Center for Vaccine Development. “Both UTMB and VaxInnate are committed to furthering development of this vaccine which can be produced within just a few months, allowing for a quicker response to emerging flu strains.”

This study is supported by a $9.5 million grant from the Bill & Melinda Gates Foundation to UTMB to better control influenza epidemics in the developing world.

About the Approach and VaxInnate’s M2e Universal Vaccine
In developing traditional vaccines, first epidemiologists must predict which strains of the flu will be circulating the following fall and winter, and then scientists formulate a vaccine targeting the likeliest candidates. The selected flu virus strains are grown in live, fertilized chicken eggs, and then the viruses are harvested, purified and processed to recover viral antigens (proteins or fragments of the virus that elicit an immune response). Current egg-based vaccines take six to nine months to manufacture and release a year’s batch of vaccine – meaning that the process begins long before it is clear how much demand there will be for a specific vaccine, potentially making it hard to respond to public health emergencies. M2 is the influenza virus ion channel that helps the virus change its pH when it has entered a cell, a critical step in the infectious process. M2e is a conserved segment of the virus, projecting above the surface of the viral particle, making an ideal target for a flu vaccine as it would not require epidemiologists from having to identify and predict strain variants that emerge from year to year. VaxInnate’s proprietary technology attaches the antigen to Flagellin, a TLR agonist, triggering the innate immune system - an immediate response to an infection without being specific to the pathogen in question. The innate immune system, using a number of cell types and enzymes, is the more primitive of the body’s responses to infection. It also releases cytokines and other signals that stimulate a stronger adaptive immune response, including the production of antibodies that are specific to the pathogen. Physically linking flagellin to antigens leads to a more potent vaccine than just administering a mixture of the two unattached components. This method has been demonstrated to produce robust protective immune responses in animal models to several pathogens including West Nile Virus, Japanese Encephalitis Virus and Listeria, in addition to influenza.

VaxInnate’s M2e universal vaccine combines M2e with flagellin and is based on efficient recombinant antigen technology that has the potential to allow more rapid production of the vaccine and lower production costs. These features could permit influenza vaccination in large parts of the developing world that would otherwise not be vaccinated.

About VaxInnate
VaxInnate is a privately-held biotechnology company focused on developing novel, proprietary vaccines for both seasonal and pandemic 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 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 [1].