Bill & Melinda Gates Foundation, Wellcome funnel $550M into ex-GSK tuberculosis shot

The Bill & Melinda Gates Foundation and Wellcome Trust are giving a combined $550 million to push forward a tuberculosis vaccine formerly owned by GSK. The investigational shot holds the potential to become the first vaccine aimed at preventing pulmonary TB to enter the market in over 100 years.

In 2020, GSK licensed a tuberculosis vaccine—dubbed M72—to the Bill & Melinda Gates Medical Research Institute (MRI). Now, to support a phase 3 clinical trial, U.K.-based charity foundation Wellcome is providing up to $150 million and the Gates Foundation will fund the remainder needed to run the trial, which is estimated to be around $400 million.

The late-stage trial is designed to assess M72’s ability to prevent progression from latent TB infection to pulmonary TB, a serious bacterial infection that involves the lungs but can spread to other organs. The international trial is expected to enroll 26,000 people at more than 50 sites in Africa and Asia. Participants will include people living with HIV, as TB accounts for a third of deaths among people with HIV.

“Despite being curable, TB remains one of the leading causes of death in South Africa,” Nomathamsanqa Majozi, head of public engagement at Africa Health Research Institute, said in a June 28 release. “In the area where I live and work, more than half of all people have had, or will have, TB at some point in their lives. The consequences are devastating, both at a personal and a community level. M72 offers us new hope for a TB-free future.”

M72 was developed by GSK, with collaboration from Aeras and the International AIDS Vaccine Initiative. The vaccine 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. The pharma—which partnered with the Gates MRI for continued development and potential use of the M72 candidate vaccine in countries with high TB burden in 2020—will continue to provide the adjuvant for the vaccine.

Previously, a phase 2b trial linked M72 to 50% protection against progression to active pulmonary tuberculosis for three years in adults infected with the mycobacterium.    

The candidate is one of 17 investigational TB vaccines currently being evaluated in the industry. Currently, there’s only one vaccine on the market, a shot known as bacille Calmette-Guérin or BCG. The vaccine, first administered in 1921, helps protect infants and young children against severe forms of TB but its protection is more limited for adolescents and adults.

An estimated 1.6 million people died from TB in 2021, which equates to about 4,300 deaths each day. People living in low- and middle-income countries disproportionately account for most of the deaths.  

“With TB cases and deaths on the rise, the need for new tools has never been more urgent,” Bill Gates, co-chair of the Bill & Melinda Gates Foundation, said in the release. “Greater investment in safe and effective TB vaccines alongside a suite of new diagnostics and treatments could transform TB care for millions of people, saving lives and lowering the burden of this devastating and costly disease.”