-- 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 low-income countries with high TB burdens.
London, UK, 27 January 2020: Today, GSK announced that it 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 low-income countries with high TB burdens.
Dr. Thomas Breuer, Chief Medical Officer of GSK Vaccines, commented: “At GSK, we are very proud to have developed a TB vaccine candidate which has shown promising clinical trial results in adolescents and adults where the need to combat the TB epidemic is greatest. We are delighted to announce this ambitious collaboration to enable key partners to further build on and progress our scientific innovation.”
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.[4] 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.
TB is the world’s deadliest infectious disease, with 10 million new cases and 1.5 million deaths in 2018 alone.[5] The burden of disease is concentrated with over 97% of reported TB cases occurring in low- and middle-income countries.[6]
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 programme.
Philip Thomson, President, Global Affairs at GSK, said: “Today’s new agreement signals a new and exciting phase in our efforts to improve global public health through medical innovation. For us, this type of alliance means we can take a more sustainable approach to global health, focussing our efforts and expertise on science and research, while partnering with others to ensure their development and delivery.”
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 GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2018.
References
[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
Source: GSK