Aeras, a fully-integrated tuberculosis (TB) vaccine development organization, has signed an agreement with global healthcare company GlaxoSmithKline to jointly advance the clinical development of an investigational TB vaccine containing GSK's proprietary M72 antigen and AS01E adjuvant.
The new agreement comes after promising results from early stage clinical trials showed that the GSK TB vaccine candidate known as M72/AS01E has an acceptable safety and reactogenicity profile and demonstrated an immune response. Under the agreement, Aeras and GSK will each provide resources to run a multi-center proof of concept clinical trial to test the vaccine candidate in healthy adults between 18 and 50 years of age.
The phase IIb trial is scheduled to begin in Kenya, India and South Africa next year pending approvals from authorities.
"When considering the massive public health impact and costs to society of neglected diseases including tuberculosis, global financing for R&D remains critically low in this area," said Jim Connolly, president and CEO, Aeras. "Working in partnership with GSK—sharing resources, capabilities and know-how—affords us the opportunity to conduct this pivotal, multi-country proof of concept trial, getting us that much closer to potentially one day having a TB vaccine that could protect adolescents and adults from one of the world's deadliest infectious diseases."
TB continues to kill 1.4 million men, women and children annually, despite the widespread use of the currently available TB vaccine, Bacille Calmette-Guerin (BCG), in TB endemic countries. The GSK vaccine candidate developed under this new agreement is being designed to be used in addition to BCG.