Germany issues award to IAVI to support development of the MTBVAC tuberculosis vaccine candidate

NEW YORK — JULY 6, 2023 — IAVI is pleased to announce a new award has been granted by the German government to help support the late-stage development of a promising tuberculosis (TB) vaccine candidate, MTBVAC.

The German Federal Ministry of Education and Research (BMBF) through the KfW Development Bank has committed to contribute €9.2 million to IAVI over the next five years to support an innovative public-private collaboration between IAVI and partners, the Spanish biopharmaceutical company Biofabri, and the Netherlands-based Tuberculosis Vaccine Initiative (TBVI), to further their development of a safe, effective, affordable, and accessible TB vaccine.

“The world urgently needs a new, effective vaccine that can prevent TB disease in adults, adolescents, and infants to make the goal of ending TB achievable,” says Mark Feinberg, M.D., Ph.D., president and CEO of IAVI. “We are honored to receive this new award from the German government to support the development of one of the most promising TB vaccine candidates. This award provides critical support to help prepare and conduct late-stage testing of the vaccine candidate in efficacy trials in infants, as well as adolescent and adults.”

“KfW is committed to fight poverty-related and neglected infections that hamper the achievement of the sustainable development goals,” says Christoph Tiskens, director at KfW Development Bank. “Thanks to sizable and reliable support by BMBF, we have already managed to support PDPs that develop new and improved diagnostics and therapies for over a decade. Their efforts directly improve the lives and livelihoods of people in need in developing countries. Therefore, we are pleased to support IAVI and partners in making new tuberculosis vaccines a reality.”

MTBVAC is currently being developed as a more effective and potentially longer-lasting TB vaccine for newborns and for the prevention of TB disease in adults and adolescents. The candidate was designed by the Spanish researcher Carlos Martin, M.D., Ph.D., from the University of Zaragoza and Dr. Brigitte Gicquel, Ph.D., of the Institut Pasteur. The only licensed TB vaccine, the Bacille Calmette-Guérin (BCG) vaccine, was developed more than 100 years ago. BCG is largely ineffective in adolescents and adults who are most at risk of developing and transmitting the disease.

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 in vaccinated individuals. If shown to be effective, MTBVAC could have a transformative impact in high TB burden countries, significantly reducing TB-related illness and death, and breaking the cycle of TB transmission. This could deliver far-reaching public health and socioeconomic impacts at the individual, family, community, and societal levels.

This award will assist IAVI and partners in their efforts to initiate an efficacy trial in adults and adolescents and to complete the ongoing European and Developing Countries Clinical Trials Partnership (EDCTP)-supported Phase III clinical trial of MTBVAC (NCT04975178) in infants that launched in South Africa, Madagascar, and Senegal in late 2022. Through supporting an integrated product development plan, this grant will also help reduce the time to market approval by at least one to two years if the vaccine is found to be safe and effective.

Support from BMBF for MTBVAC development, jointly with support from EDCTP, will serve as an important lever to bring additional resources from other funders to this program, and to TB vaccine R&D overall.

This announcement comes amidst renewed calls from the global TB community for greatly increased investment in TB vaccine development, in line with the ambitions and targets outlined in the Global Plan to End TB 2023-2030. IAVI urges funders, especially from the public sector, to commit additional resources for TB vaccine R&D and join the German government in supporting the late-stage testing of other promising TB vaccine candidates in the pipeline.

If MTBVAC is shown to be safe and effective, IAVI, in partnership with Biofabri, will ensure that MTBVAC is manufactured and supplied in sufficient quantities to neonates, infants, adolescents, and adults 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 deadliest 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. 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 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 Phase II safety/immunogenicity study of MTBVAC in people living with HIV (PWHIV) is being planned.

KfW Development Bank has been helping the German Federal Government to achieve its goals in development policy and international development cooperation for more than 60 years. In this regard, we are both an experienced bank and a development institution with financing expertise, an expert in knowledge of development policy, with many years of national and international experience. On behalf of the German Federal Government, and primarily the Federal Ministry for Economic Cooperation and Development (BMZ), we finance and support programmes and projects that mainly involve public sector players in developing countries and emerging economies — from their conception and execution to monitoring their success. Our goal is to help our partner countries fight poverty, maintain peace, protect both the environment and the climate, and shape globalisation in an appropriate way.

The MTBVAC development partnership: 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 is a nonprofit scientific research organization with offices and labs in the U.S., U.K., 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 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.

The Tuberculosis Vaccine Initiative (TBVI) is a non-profit foundation that enables the discovery and development of new, safe, and effective tuberculosis vaccines that are accessible and affordable for all people. As the Product Development Association (PDA), TBVI integrates, translates, and prioritizes R&D efforts to discover and develop new TB vaccines and biomarkers for global use. TBVI provides essential services that support the R&D efforts of its partners: 50 partners from academia, research institutes, and private industry in the field of TB vaccines.

The University of Zaragoza (UNIZAR) 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 TBVI consortium, the MTBVAC discovery phase has included rigorous clinical characterization by independent laboratories and research groups.