• TB kills 1.6 million people a year, causing more deaths than any other single infectious disease apart from COVID-19, and sickens more than 10 million people annually. 
• A new TB vaccine is needed to reach global END TB goals. 
• MTBVAC is a highly promising vaccine candidate that has the potential to be used as an alternative to BCG vaccination in infants and for prevention of TB disease in adolescents and adults. 

PORRIÑO, SPAIN, and NEW YORK, U.S. — MAY 17, 2023—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, today announced the signing of 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.Theonly 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.

TB 

Since the COVID-19 emergency has ended, TB is on track once again to be the most deadly infectious disease in the world, killing an estimated 1.6 million people in 2021, about 14% of whom were children. Around 10.6 million people fell ill with tuberculosis in 2021, and the disease is one of the 10 leading causes of death worldwide. 

COVID-19 has reversed previous advances in TB response by 10 years, causing significant decreases in TB case detection. The Stop TB Partnership estimates that an additional 1.4 million TB deaths will occur over the next four years because of COVID-19. A vaccine is needed more urgently than ever.

Drug-resistant/multi-drug resistant TB (DR/MDR TB) is becoming an increasing threat, with about 450,000 cases in 2021. DR/MDR TB treatment is arduous, expensive, and not always successful. A vaccine that prevents TB disease would have a major impact on the DR/MDR TB problem.

MTBVAC

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 TB disease in adults and adolescents, for whom there is currently no effective vaccine.

Two Phase II trials have been completed, one supported by EDCTP and sponsored by Biofabri in infants in South Africa, and one sponsored by IAVI and supported by the U.S. National Institutes of Health and the U.S. Department of Defense through its Congressionally Directed Medical Research Program. Results are expected to be published in later 2023.

A global project 

This agreement takes a further step in advancing the development of a promising TB vaccine candidate, especially for low- and middle-income countries, in a project in which the following partners play an essential role: 

IAVI. 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 (including COVID-19), and neglected diseases, with the goal of providing global access. It has contributed to efforts to evaluate most of the leading TB vaccine candidates now in clinical development and has a highly experienced TB vaccine clinical research team in South Africa.

Biofabri. Biofabri is a biopharmaceutical company created in 2008 with the aim of researching, developing, and manufacturing vaccines for humans. Biofabri has a solid technical and scientific capacity in vaccines and immunotherapy. Biofabri belongs to the Zendal group, a Spanish pharmaceutical business group made up of six companies specialised in the development, manufacture and marketing of vaccines and other biotechnological products for human and animal health.

UNIZAR. The University of Zaragoza in Spain is the main center for technological innovation in the Ebro Valley. It participates in different exchange programs, collaborating with universities and research centers in Europe, Latin America, and the United States. Microbiologists from the university associated with Centro de Investigación Biomédica en Red Enfermadades Respiratorias (CIBERES) led the research and subsequent discovery of the experimental vaccine MTBVAC. Within the TuBerculosis Vaccine Initiative (TBVI) consortium, the MTBVAC discovery phase has included rigorous clinical characterization by independent laboratories and research groups.