Spanish biopharmaceutical company Biofabri, a subsidiary of Zendal, and IAVI, an international nonprofit research organization focused on developing vaccines and antibodies against infectious and neglected diseases, have signed an agreement for end-to-end development of the tuberculosis (TB) vaccine candidate MTBVAC. This agreement provides a framework for the future of the collaboration that the partners first announced in 2021.
Under the agreement, IAVI is supporting development, global regulatory strategy, resource mobilization, and access planning for the adolescent/adult MTBVAC program. This includes an efficacy trial, which IAVI plans to begin in 2024 after securing sufficient funding.
With support from the European & Developing Countries Clinical Trials Partnership (EDCTP), Biofabri launched a Phase III trial of MTBVAC (NCT04975178) in neonates in South Africa, Madagascar, and Senegal in late 2022. IAVI will support the MTBVAC infant program, including bringing in additional resources to enable late-stage development, with other expanded roles in the program being planned.
MTBVAC, designed by the Spanish researcher Dr. Carlos Martin from the University of Zaragoza and Dr. Brigitte Gicquel of the Institut Pasteur, was in-licensed by Biofabri. It is one of the most promising new TB vaccines in the pipeline. The only available TB vaccine, bacille Calmette-Guérin (BCG), has limited effectiveness at preventing pulmonary TB in adults and adolescents, who are mainly responsible for spreading TB. MTBVAC is the only live, attenuated Mycobacterium tuberculosis vaccine in the pipeline. Given its derivation from the human, rather than bovine, TB organism, MTBVAC has the potential to maximize the breadth of immune response.
“The world urgently needs a new, effective vaccine that can prevent TB disease in adults, adolescents, and infants,” said Dr. Mark Feinberg, president and CEO of IAVI. “We are honored to be working with Biofabri and our other collaborators to advance MTBVAC. We are actively seeking the support of global health funders and other partners, public and private, to ensure that this promising vaccine candidate has the potential to be part of a solution to ending the TB epidemic.”
“Biofabri and the Zendal Group look forward to realizing the full potential of MTBVAC with IAVI. With their partnership and that of our other collaborators we hope to reach our goal of making a TB vaccine available throughout the world,” said Esteban Rodríguez, Biofabri CEO.
“We are gratified that Phase II dose-ranging studies in adults and neonates demonstrated favorable immunogenicity data and a favorable safety profile. If results of the ongoing and planned efficacy trials bear fruit, we will be proud to be manufacturing a Spanish-designed, globally relevant lifesaving vaccine locally.”
Should MTBVAC be shown to be safe and efficacious, Biofabri, in partnership with IAVI and other collaborators, will ensure that MTBVAC is manufactured and supplied in sufficient quantities globally and is accessible at affordable prices in low- and middle-income countries.
