“Zendal’s Biofabri and IAVI Sign Agreement for MTBVAC Tuberculosis Vaccine Development”

Biofabri, the Galician subsidiary Zendaland IAVI, an international non-profit research organization focused on the development of vaccines and antibodies against infectious and neglected diseases, have announced the signing of an agreement for the comprehensive development of MTBVAC, tuberculosis vaccine candidate (TB) that it develops in its laboratories in O Porriño.

Under the agreement, IAVI is supporting the development, resource mobilization, access planning, and overall regulatory strategy for the program. MTBVAC for teens and adults. This includes an efficacy trial that IAVI plans to start in 2024, after funding is secured.

tuberculosis vaccine trial

With the support of the European and Developing Countries Association for Clinical Trials (EDCTP), Biofabri launched a phase III trial of MTBVAC in newborns in South Africa, Madagascar and Senegal by the end of 2022.

MTBVAC is being developed for two purposes: as a more effective and potentially longer-lasting vaccine than BCG for newborns and for the prevention of tuberculosis disease in adults and adolescents, for whom there is currently no effective vaccine.

Two Phase II trials in neonates have been completed, one supported by EDCTP and sponsored by Biofabri in South Africa, and one sponsored by IAVI and supported by the US National Institutes of Health and the US Department of Defense through their Congressionally Directed Medical Research Program. The results are expected to be published by the end of 2023.

Pioneer drug

The vaccine was designed by the Spanish researcher Carlos Martín, from the Zaragoza’s Universityand Dr. Brigitte Gicquel, from the Pasteur Institute and developed by Biofabri.

MTBVAC is currently the only live attenuated Mycobacterium tuberculosis vaccine in development and, since it is derived from Mycobacterium tuberculosis isolated from a human (versus BCG, Mycobacterium bovis from a cow), it has a potentially higher immune responsiveness.

“The world urgently needs an effective tuberculosis vaccine that can prevent the disease in adults, adolescents and children,” said IAVI President and CEO Dr. Mark Feinberg.

Financing search

The president of IAVI also assures that «are actively seeking support from global health funders and other partners, public and privateto ensure that this promising vaccine candidate has the potential to be part of a solution to end the tuberculosis epidemic.”

“We are pleased that variable dose Phase II studies in adults and neonates have demonstrated favorable immunogenicity data and a favorable safety profile. If the results of the ongoing efficacy trials bear fruit as we hope, we will be proud to manufacture in Spain a world-class vaccine to save lives“, declares the CEO of Biofabri, Esteban Rodríguez.

Should MTBVAC prove to be safe and effective, Biofabri, in collaboration with IAVI, will ensure that this vaccine is manufactured and supplied in sufficient quantities to newborns, infants, adolescents and adults and is accessible and affordable in the countries of middle and low income.