VaxInnate starts Phase 1 clinical trial to evaluate VAX2012Q for prevention of seasonal influenza

VaxInnate Corporation today announced that enrollment has commenced in a Phase 1 clinical trial to evaluate VAX2012Q, a recombinant quadrivalent vaccine in development for the prevention of seasonal influenza. VaxInnate is a biotechnology firm pioneering a breakthrough technology platform for the development of novel vaccines.

The VAX2012Q clinical trial is being funded in whole with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS), under Contract No. HHSO100201100011C. The trial, which is taking place at four sites in the United States, will evaluate the safety and immunogenicity of VAX2012Q.

VAX2012Q is a dose escalation study. Up to 320 healthy adults aged 18-40 will receive VAX2012Q by intramuscular injection. The subjects will be evaluated in the clinic 21 days and six months post-vaccination, and followed for one year. The study is expected to yield data that will enable VaxInnate to select the appropriate dose of VAX2012Q for further development. Results are anticipated by the end of 2014.

"We're pleased to advance VAX2012Q into clinical development with this study, which will enable VaxInnate to optimize the dose of this vaccine," said Wayne Pisano, President and CEO of VaxInnate. "We believe VAX2012Q has the potential to be an effective and much-needed option for the prevention of seasonal flu, which remains a significant public health problem."

Seasonal influenza viruses cause mild to severe illness, hospitalizations and deaths every year in the United States and the rest of the world. Certain populations are at greater risk for serious complications if they contract the flu, including the elderly, children under age five and pregnant women. Others at high risk of developing serious flu-related complications are people with certain health conditions, among them asthma, chronic lung diseases, heart disease, diabetes and weakened immune systems due to diseases such as cancer and HIV infection. Annual vaccination is the best way to prevent the flu.

Promising Technology Platform

VaxInnate's technology platform is based on proprietary Toll-like Receptor (TLR) technology, which potentiates the immune response. The TLR technology genetically fuses vaccine antigens to the bacterial protein flagellin, and this sequentially triggers the innate and adaptive immune systems.

Using this technology, vaccines can be produced using low-cost, highly-scalable, recombinant DNA techniques, thus avoiding many of the challenges of conventional vaccine production. This technology has the potential for production of significantly greater quantities of vaccine in extremely rapid timeframes, with very low infrastructure costs.