Medicago is a clinical-stage biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs). Medicago’s VLP manufacturing technology is based on a transient expression system which produces recombinant vaccine antigens in non-transgenic plants. This technology has the potential to offer speed and cost advantages over competitive technologies. It can deliver a vaccine for testing in less than a month after the identification and reception of genetic sequences from a pandemic strain. This production time frame has the potential to allow vaccination of the population before the first wave of a pandemic strikes and to supply large volumes of vaccine antigens to the world market. Medicago’s VLPs resemble a virus, allowing them to be recognized readily by the immune system however they lack the core genetic material, making them non-infectious and unable to replicate. The Company is using tobacco leaves to produce pandemic and seasonal influenza VLP vaccines for clinical testing. Medicago is also developing non-influenza vaccine candidates using this innovative plant-derived VLP platform.
Medicago recently reported positive results from its Phase II clinical trial with its avian flu H5 pandemic vaccine candidate. The vaccine was found to be safe, well tolerated and the results were among the most effective of the industry. Medicago also reported positive results from a U.S. Phase I human clinical trial with its seasonal influenza vaccine candidate. All vaccine doses were found to be safe, well tolerated and also induced a solid immune response that met the CHMP criteria, even with a single dose of 5 µg. Based on these results and subject to regulatory approval, Medicago intends to proceed with a U.S. Phase IIa trial for its seasonal trivalent vaccine with the recommended H1N1, H3N2 and B influenza strains.
Medicago operates a 24,000-square-foot production facility located in the Technology Park in Quebec City, Canada. This facility includes a Biosafety level 2 greenhouse, an extraction and purification unit, and is cGMP compliant. Medicago is producing the preclinical and clinical lots required for the development of its influenza vaccines from its existing facility.
Medicago U.S.A., a wholly owned subsidiary of Medicago Inc., has commenced the construction of its cGMP facility in Research Triangle Park (RTP), North Carolina. This vaccine facility will include a fully automated greenhouse and a state of the art extraction and purification unit. The 97,000-square-foot cGMP facility will have the capacity to produce more than 40 million doses of seasonal influenza vaccine or 120 million doses of pandemic influenza vaccine a year. The facility is scheduled to be complete in 2011.