The Bill & Melinda Gates Medical Research Institute obtains license for continued development of M72/AS01E tuberculosis vaccine candidate from GSK

• The M72/AS01E tuberculosis vaccine candidate demonstrated in a phase IIb trial the potential to reduce active pulmonary TB by half in adults with latent TB infection.(1)


• Developing a new vaccine against TB is a global health priority to accelerate progress toward ending the TB epidemic(2) and one of the United Nations Sustainable Development Goals.


• The licensing agreement is a significant step forward to continue the development of the vaccine candidate for countries with high TB burdens.

SEATTLE, January, 27, 2020 – Today, 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 Gates MRI.

TB is the world’s deadliest infectious disease, with 10 million new cases and 1.5 million deaths in 2018 alone.(4) The burden of disease is concentrated with over 97% of reported TB cases occurring in low- and middle-income countries.(5)

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.(6) The development of such a vaccine has been a long-standing strategic objective for the Gates Foundation. 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 Bill & Melinda 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.”

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.

About the vaccine candidate

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. Funding for research which uncovered the potential of M72 was provided by the United Kingdom’s Department for International Development (DFID), the Directorate-General for International Cooperation (DGIS) in the Netherlands, the Australian Department for Foreign Affairs and Trade (DFAT), the European Commission and the Bill & Melinda Gates Foundation.

About tuberculosis

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.

About the Bill & Melinda Gates Foundation

Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Sue Desmond-Hellmann and Co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett. For further information please visit www.gatesfoundation.org.

About the Bill & Melinda Gates Medical Research Institute

The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization conducting clinical research to accelerate product development for diseases and disorders that disproportionately affect the world’s poorest populations—malaria, tuberculosis, diarrhea and maternal and newborn child health conditions that combined cause ten deaths every minute. For further information please visit www.gatesmri.org. 

(1) Tait et al. N Engl J Med 2019; 381:2429-2439
(2) Knight et al. PNAS 2014.
(3) The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes
(4) WHO, Global Tuberculosis Report, 2019
(5) WHO, Global Tuberculosis Report, 2019
(6) WHO, Global Tuberculosis Report, 2019

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