Medicago Vax Heads to Phase III

The revolutionary flu vaccine being developed by Medicago for production in its nearly completed Research Triangle Park manufacturing facility is behaving just as the company hoped.

The company disclosed today that the experimental vaccine, made from virus-like particles (VLP) grown in the cells of tobacco leaves, had a positive outcome from a Phase II human clinical trial, showing its safety and helping to establish optimal dosing in varying patient populations. So the H5N1 avian influenza (so-called bird flu) preventive will enter Phase III trials in the next few months.

"These positive Phase II clinical trial results continue to demonstrate that our rapid plant-based vaccine technology produces VLP vaccines that are safe and among the most effective of the industry," said Andy Sheldon, Medicago president and CEO. "We soon expect to have the capacity to commercially produce these vaccines as our U.S. vaccine facility in North Carolina will be operational this fall.”

The $42 million facility, with its specialized greenhouses, received some $21 million in federal funding from the Department of Defense. Medicago will employ some 85 people at the site.

Faster to market with pieces and parts

Medicago believes VLPs have several advantages over traditional flu vaccines.

• They are made to look like a virus, allowing them to be recognized readily by the body's immune system, but they lack the core genetic material of a virus, making them non-infectious and unable to replicate.
• Medicago's technology only requires the genetic sequence of a viral strain and not the live influenza virus. So the company can crank out a vaccine against a pandemic flu strain within a month after health officials identify the infection, rather than the six to nine months required for traditional vaccine development in chicken eggs.

Though its corporate headquarters is in Quebec City, Medicago has quickly integrated into the innovative and business-friendly North Carolina life-science scene with its RTP campus.

For example, the company is a platinum-level sponsor of the North Carolina Pavilion at the BIO 2011 international convention in Washington, D.C.

Medicago is the newest in a globally significant group of vaccine manufacturers that has made North Carolina a world leader in the field.

Its technology also contributes to North Carolina's fast-growing leadership in agriceuticals -- therapeutics grown in plant cells.