Phase IIb proof of concept trial planned for Kenya, India and South Africa
Aeras, a non-profit TB vaccine biotech, has signed a novel research and resource-sharing agreement with GlaxoSmithKline Vaccines (GSK) jointly to advance the clinical development of an investigational tuberculosis (TB) vaccine containing GSK's proprietary M72 antigen and AS01E* adjuvant.
The 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. Aeras and GSK will each provide resources to run a multicentre 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.
‘This partnership signals our commitment to building innovative collaborations to develop and deliver new TB vaccines,’ said Jim Connolly, president and CEO of Aeras. ‘We will never reverse the spread of the global TB epidemic without new vaccines as part of the solution.
‘Working in partnership with GSK – sharing resources, capabilities and know-how – affords us the opportunity to conduct this pivotal, multicountry 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. BCG prevents some forms of TB in infants but does not prevent pulmonary TB, which accounts for the majority of infections and deaths among adolescents and adults. The GSK vaccine candidate developed under this new agreement is being designed to be used in addition to BCG.
Contains QS-21 Stimulon adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus.