Biopharmaceutical company Biofabri and IAVI announced on July 14, 2021, their intention to partner on efficacy trials of the tuberculosis (TB) vaccine candidate MTBVAC.
Designed by the Spanish researcher Dr. Carlos Martin from the University of Zaragoza, MTBVAC was in-licensed by Biofabri in collaboration with the University of Zaragoza, IAVI, and the Tuberculosis Vaccine Initiative (TBVI). TBVI will also support the ongoing clinical trial preparations.
MTBVAC intends to complete Phase II evaluation in 2021.
The only available TB vaccine is the 100-year-old bacille Calmette-Guérin (BCG), which does not prevent primary infection and has limited effectiveness at preventing pulmonary TB in adults, who, along with adolescents, are mainly responsible for spreading TB.
A study published by the journal Nature in January 2021 showed that a single dose of MTBVAC provides significantly better protection against aerosol exposure to Mycobacterium tuberculosis in rhesus macaques compared to BCG at the same dose.
The European and Developing Countries Clinical Trials Partnership (EDCTP) has committed to supporting a Phase III trial of MTBVAC in newborns, scheduled to begin in several African countries in 2021.
IAVI will support the development and further resource mobilization for MTBVAC, including for an adolescent/adult trial.
TB has been the biggest infectious disease killer globally, killing an estimated 1.4 million people each year, 10% of whom are children. Around 10 million people fell ill with TB in 2019, says the WHO.
Furthermore, drug-resistant/multi-drug resistant TB is becoming an increasing problem, with about 465,000 cases confirmed in 2019.
IAVI is a nonprofit scientific research organization with headquarters in the U.S. and locations in Europe, Africa, and India that develops vaccines and antibodies for HIV, tuberculosis, emerging infectious diseases, and neglected diseases, with the goal of global access.
Biofabri is a Spain-based biopharmaceutical company created in 2008 to research, develop, and manufacture vaccines for humans.