February 2, 2009

Fraunhofer, a non-profit research group in north-eastern US, Newark, has received an US$8.7 million grant from the nation's largest foundation to continue development of a plant-based vaccine for bird flu.

The grant builds on a US$2.6 million award to Fraunhofer two years ago from the Bill & Melinda Gates Foundation to find potential flu vaccines.

Fraunhofer's executive director, Vidadi Yusibov said the latest grant shows the foundation believes Fraunhofer's technology, which makes vaccine materials by coaxing plants into producing certain proteins that can yield commercially viable vaccines.

Yusibov said the grant will help to establish all the processes of making a suitable product that can take into human trials.

Fraunhofer's research is targeting the H5N1 virus, and the group is working with commercial partner iBioPharma Inc., a Newark biotech firm that has an exclusive license on Fraunhofer's plant-based technology.

Gates Foundation senior program officer, Doug Holtzman said if successful, this project could help developing countries respond quickly to outbreaks of influenza and other infectious diseases to significantly limit their impact on vulnerable populations.

Yusibov said Fraunhofer will seek FDA's guidance on conducting toxicity studies in animals for its vaccine candidate which will be used to submit an investigational new drug application with the FDA.

If the application is approved, Fraunhofer could begin Phase 1 trials to test the vaccine candidate's safety in humans.

Yusibov expects the Gates Foundation grant to carry development to the end of Phase 1 trials, after which the research partners would look for a larger commercial partner with vaccine development experience to help take the product to market.

Bird flu is a contagious disease that has largely been confined to animals. WHO has tracked 403 human cases of a virulent flu strain known as H5N1, resulting in 254 deaths, most of those in Asia.

But the WHO warns that the virus could mutate and become as contagious as normal influenza, causing a pandemic of widespread illness and millions of deaths worldwide.