NIBIO signs collaboration agreement for clinical development of new mucosal TB vaccines

Japan's National Institute of Biomedical Innovation ("NIBIO"), Aeras and Create Vaccine Company, Ltd ("CREATE") announce today that they signed a collaboration agreement on December 26, 2013, on the preclinical and clinical development of new mucosal tuberculosis (TB) vaccines based on NIBIO's human parainfluenza type-2 (rhPIV2) vector technology.

"These will be important candidates; designed to target mucous membranes to keep TB from entering the lungs," said Tom Evans, MD, President and CEO of Aeras, a nonprofit biotech advancing TB vaccines globally. "This type of collaboration among global experts is exactly the approach needed to find an effective vaccine that will end tuberculosis in Japan and around the world."

The collaboration is supported through a generous grant from the Global Health Innovative Technology Fund (GHIT), a new partnership formed to facilitate international partnerships that enable Japanese technology, innovations, and insights to play a more direct role in reducing disparities in health between the rich and the poor of the world.

The vaccine platform was created by Tsukuba Primate Research Center at NIBIO. "Based on the promising results of early research and the improved safety profile of candidates using this rhPIV2 platform, we believe that this platform has great possibility," said Dr. Yasuhiro Yasutomi (Director of Tsukuba Primate Research Center, NIBIO). "Further studies contribute to the ultimate goal of establishing a new vaccine strategy that can definitely prevent TB."

CREATE is a joint venture company created by Dainippon Sumitomo Pharma and Japan BCG Laboratory to develop and market TB vaccines developed in partnership with NIBIO and Aeras.

The collaboration announced today will advance vaccine candidates based on the rhPIV2 technology through preclinical stages with a goal to advance to safety and immunogenicity testing in clinical trials. The partners will collaborate jointly to establish development criteria and assess progress through agreed upon development milestones. This will include the characterization of new vaccine constructs with a variety of antigens, the conduct of immunology studies to identify the most promising novel vaccines and the establishment of current good manufacturing practices (cGMP).

"Development of TB vaccines is a new challenge." said Koichi Kozuki, President of CREATE. "The exciting partnership among NIBIO, Aeras and CREATE will accelerate development efforts for clinical application of new TB vaccines to the patients who need it."

TB is one of the deadliest and most disabling diseases in the world today. Each year, more than 8.6 million people become sick with TB and 1.3 million people die of the disease. Although its burden is spread across all age groups, it exacts its greatest toll on individuals during their most productive years, from ages 15 to 44. The global emergence and spread of multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), now found in all countries surveyed worldwide, are confounding efforts to halt the spread of TB and are imposing enormous personal costs and a significant economic burden on national health systems. The cost of treating MDR-TB can be 200 times greater than for drug-susceptible TB. In Japan every year, more than 20,000 people contract TB and more than 2,000 die from the disease.