Data from Two Phase II Clinical Trials Conducted by Aeras and Partners Indicate Promise for Future of TB Vaccine Development
NEW YORK – OCTOBER 1, 2018 – The International AIDS Vaccine Initiative (IAVI) and Aeras, a nonprofit organization dedicated to developing tuberculosis (TB) vaccines, today announced the transfer to IAVI of Aeras’ TB vaccine clinical research programs and assets, consisting of certain clinical staff, clinical programs, biorepository, funding commitments, and other assets.
The transaction, effective today, will enable the continuity of Aeras’ core TB vaccine clinical programs and will expand IAVI’s clinical development capabilities and network, incorporating an experienced clinical team and South African clinical partner network with a strong track record in later-stage clinical trials and work with adolescent and adult populations.
This agreement comes as the New England Journal of Medicine (NEJM) published the results of a clinical study conducted by Aeras in collaboration with GSK, evaluating GSK’s investigational TB vaccine candidate, M72/AS01E. The Phase IIb efficacy study showed that the vaccine protected against active pulmonary TB disease, with an overall vaccine efficacy of 54 percent. This finding, if confirmed in follow-up studies, would represent a breakthrough in the decades-long quest to develop an effective TB vaccine. The study involved 3,573 HIV-negative adults in three countries in Africa (Kenya, South Africa, and Zambia).
These results follow another Aeras Phase II study recently published in the NEJM showing the potential to prevent sustained TB infection among high-risk adolescents. The study involved the currently available bacille Calmette-Guerin (BCG) vaccine and an experimental subunit vaccine candidate, H4:IC31®, which uses the IC31® adjuvant available under license from Valneva. The study was conducted through a partnership between Aeras and Sanofi.
Mark Feinberg, M.D., Ph.D., president and CEO, IAVI, said, “Aeras’ contributions to these two important studies have built excitement in the field, demonstrating that an effective TB vaccine may be achievable. The transfer of Aeras research capabilities to IAVI will enable this important work to continue.” Dr. Feinberg continued, “There is extensive overlap among individuals and communities hit hardest by TB and HIV/AIDS; TB is the single biggest killer of people living with HIV, and, in some parts of the world, the HIV pandemic has fueled the spread of TB. The expertise of the Aeras clinical operations team and South African network will enable IAVI to strengthen its clinical development capacity and enhance its ability to address HIV, TB, and other important global health challenges. We are looking forward to working with public and private sector partners to develop new technologies and programs to help control the TB pandemic.”
Jacqueline Shea, Ph.D., CEO, Aeras, said, “Aeras is proud of the contribution it has made to the field of TB vaccine research and development and the role that it has played in two recent groundbreaking clinical efficacy trials. For more than two decades, Aeras has formed partnerships with commercial biopharmaceutical companies, other nonprofits, researchers, funders, and global health experts in its mission to advance TB vaccines for the world. We believe that the time is right to join the expertise within Aeras and IAVI to build on the recent findings and accelerate progress toward new, more effective TB vaccines. We believe such progress will also require additional partnerships among like-minded and committed organizations.”
Eric Goosby, M.D., U.N. Secretary-General’s Special Envoy on Tuberculosis and board chair, IAVI, said, “Following the first-ever United Nations high-level meeting on TB, it is important to emphasize that a vaccine is necessary to achieve control over TB on a global level. Without vaccines to both prevent and treat the disease, the pandemic will continue. These recent studies bring us one step closer to a solution.”
Further information about the M72/AS01E study is available here.
Tuberculosis (TB) is the world’s deadliest infectious disease and is increasingly characterized by antimicrobial resistance. In 2017, there were 1.6 million deaths and 10 million new cases of TB disease. The World Health Organization (WHO) estimates that nearly one-quarter of the world’s population has latent TB infection, meaning that they are infected with TB bacteria that could develop into active TB disease. Teens and adults are most at risk for developing and spreading TB.
An estimated 19 percent of TB-related deaths, and 9 percent of new TB cases, were among people living with HIV. The risk of developing TB disease is estimated to be 20 times higher among the 37 million people living with HIV than it is for those without, and TB accounts for about one in three AIDS-related deaths.
The International AIDS Vaccine Initiative (IAVI) is a nonprofit scientific organization whose mission is to develop vaccines and other biomedical innovations that prevent HIV infection. Since its founding in 1996, IAVI has provided scientific, research and development, and policy leadership to address the needs of communities and key populations at risk for HIV infection around the world. IAVI works with more than 100 academic, industry, government, civil society, clinical, and community partners in more than 25 countries. IAVI is committed to supporting the broad field of HIV vaccine research and to fostering collaborations that accelerate the development and availability of new prevention tools. In pursuit of our goals, we work to catalyze and support novel partnership models that engage partners from both the public and private sectors across the product development continuum.
IAVI’s global reach, including its clinical research network in five countries in sub-Saharan Africa and in India, has allowed IAVI to make fundamental contributions to understanding of the epidemiology, transmission, natural history, virology, and immunology of HIV infection. This work played a key role in facilitating the structure-based design of promising HIV vaccine candidates as well as the discovery of “broadly neutralizing antibodies” that are now being advanced as promising approaches for HIV prevention. IAVI’s integrated capabilities in vaccine discovery, development, and clinical research take advantage of biopharmaceutical industry expertise to accelerate the development and testing of novel HIV vaccine candidates.
In addition to its core HIV vaccine effort, IAVI is working to amplify its global health impact by working with partners to address other urgent unmet public health needs – such as vaccines for other infectious diseases – where our existing technologies, assets, and experience can add unique value.
Aeras is a nonprofit organization advancing the development of new TB vaccines for the world in partnership with other biotech, pharmaceutical, and academic organizations. Aeras is primarily funded by the Bill & Melinda Gates Foundation, the U.K. Department for International Development (DFID), and other parties committed to ending the tuberculosis epidemic. Aeras also receives support from the U.S. government and through partnerships and collaborations with universities and biopharmaceutical companies around the world. Aeras is headquartered in Rockville, Maryland (USA), with a clinical development and operations office in Cape Town, South Africa. For more information, please visit www.aeras.org.
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