GSK hands TB vaccine to Gates Foundation's nonprofit biotech

Bill Gates
Bill Gates (CC BY 2.0/Ben Fisher/GAVI Alliance)

GlaxoSmithKline has licensed a tuberculosis vaccine to the Bill & Melinda Gates Medical Research Institute (MRI). The deal sets the stage for a push to build on recent phase 2b data and make the vaccine available in low-income countries where TB is prevalent.

The vaccine, M72/AS01E, is made up of an immunogenic fusion protein based on two TB antigens. GSK combined that protein with the adjuvant found in its shingles prophylactic Shingrix to create a subunit vaccine. Last year, a phase 2b trial linked the vaccine to 50% protection against progression to active pulmonary tuberculosis for three years in adults infected with the mycobacterium.

Gates Foundation funding supported one of the organizations involved in the phase 2b. Now, Gates MRI, the nonprofit biotech offshoot of the foundation, has struck a deal to play a bigger role in the next steps in the development of the vaccine.

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Gates MRI has licensed the vaccine from GSK. Having done so, Gates MRI will lead development of the vaccine and sponsor future clinical trials. GSK will continue to supply the adjuvant, AS01, but will otherwise step back from the program.

In a statement to disclose the news, GSK framed the licensing deal as a way to support the continued development of the vaccine for use in low-income countries with high TB burdens. The focus on such populations gives the vaccine limited commercial potential, but the financial model of Gates MRI means it is insulated from such concerns.

Rather, Gates MRI can focus on the unmet medical need. With the World Health Organization (WHO) calculating TB kills more people than any other single pathogen, there is a need for vaccines that prevent infections or stop infections from manifesting as active pulmonary tuberculosis. The WHO responded to that need by publishing a preferred product characteristics document that outlined the need for vaccines that have 50% efficacy against tuberculosis for at least two years.

The phase 2b data suggest M72/AS01E may be able to meet the WHO’s vaccine brief. Responsibility for finding out whether that is the case will fall on Gates MRI.

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