The Bill & Melinda Gates Medical Research Institute (Gates MRI) and the Bill & Melinda Gates Foundation (Gates Foundation) announced that GSK has licensed its M72/AS01E(3) tuberculosis disease (TB) vaccine candidate to the Gates MRI, paving the way for continued development and potential use of the vaccine candidate in countries with high TB burdens.
“Clinical trial results to date suggest that the M72/AS01E vaccine candidate could play a significant role in protecting vulnerable populations around the world from developing active TB. If that proves true, it could transform the fight against humanity’s deadliest infectious disease,” said Penny M. Heaton, M.D., CEO of the Gates MRI.
There is no approved vaccine capable of preventing pulmonary TB disease in adolescents and adults, who accounted for 89% of people who fell ill with TB in 2018. The live attenuated vaccine, Bacille Calmette-Guerin (BCG), has been in use for nearly a century, and while it is effective in preventing severe TB disease in infants and young children, it provides limited protection against pulmonary TB in adolescents and adults. The Gates Foundation and the Gates MRI are also exploring an expanded use of the BCG vaccine to prevent TB in healthy adolescents in a separate clinical program.
“Right now, we don’t have all of the tools we need to accelerate global progress against TB,” said Trevor Mundel, President of Global Health at the Gates Foundation. “Discovering and developing a new TB vaccine is a Gates Foundation priority, and we look forward to working in partnership with stakeholders in the global health community towards this goal.”
The M72/AS01E vaccine candidate contains the M72 recombinant fusion protein, derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A), combined with the Adjuvant System AS01. The vaccine candidate has been developed by GSK in conjunction with IAVI. Recently published final results of a phase IIb trial in South Africa, Kenya and Zambia conducted in partnership with IAVI showed that M72/AS01E had an acceptable safety profile and reduced cases of TB in HIV-negative adults with latent TB infections by half. The Gates MRI will lead vaccine candidate development and sponsor future clinical trials. GSK will provide the AS01 adjuvant for this development program.
TB causes more deaths annually than any other infectious disease, with 10 million new cases and 1.5 million deaths recorded in 2018. Though the number of deaths is falling, the currently estimated global rate of TB decline remains about 2.0%. This rate is insufficient to achieve the 2030 United Nations Sustainable Development Goals target of an 80% reduction in TB compared with 2015. TB is also the leading killer of people living with HIV, accounting for one-third of deaths among HIV-positive people. The world’s most vulnerable populations are disproportionately affected by TB, with many cases of TB occurring in resource-limited areas.
Currently, there is no effective way to prevent the spread of TB, which is a contagious bacterial disease, and tools for diagnosing and treating the disease are also inadequate.
