Public Release:  Award to Aeras boosts historic hunt for new TB vaccines, as drug resistance proliferates

Grant represents vital step in meeting urgent global need to fund worldwide scientific efforts to eliminate airborne threat

Aeras

This release is also available in Chinese on EurekAlert! Chinese.

Rockville, MD, USA | Cape Town, South Africa (March 15, 2012) - Aeras announces today the receipt of a grant by the Bill & Melinda Gates Foundation of up to US $220 million over five years, placing it at the forefront of a global scientific initiative aimed at developing safe, effective vaccines against tuberculosis, a disease that infects two billion people worldwide. One of the world's largest not-for-profit biotechs, Aeras is developing modern vaccines to combat TB against the backdrop of a significant increase in drug-resistant strains.

"We are grateful to the Bill & Melinda Gates Foundation for their continued confidence in Aeras and their support of our efforts to develop vaccines against a disease that costs the global economy billions of dollars annually, and hits hardest in the nations of Africa and Eastern Europe, and the emerging economic powerhouses of Asia," said Jim Connolly, President and Chief Executive Officer of Aeras. "This infusion of funding must be seen as a global call to action in response to one of the world's deadliest diseases. It will allow Aeras to expand upon existing partnerships in Europe, Africa, China, and around the world, and to build new partnerships that will accelerate the development of safe and effective vaccines. But the scientific challenges are immense, and the threat is global. Without support for this search for new vaccines from every quarter, we will never eliminate TB as a global health threat."

Globally, the TB vaccine field estimates it will need in excess of US$1 billion over the next five years to support worldwide efforts against a disease so complex it is expected to require more than one vaccine to address geographic variations in the strains, different stages of disease, and a variety of target populations. Aeras estimates US $400-500 million will be needed over the next five years if the organization is to accomplish critical TB vaccine development goals set jointly with global research and development partners. This grant provides approximately half of the estimated cost of meeting 2012-2016 milestone targets, while addressing significant scientific questions that must be answered in order to further successful development of new vaccines.

"There is an urgent need for the global community to support the full range of tools to eliminate tuberculosis, but the development of TB vaccines that can prevent men, women and children from developing the disease would be the single greatest advance in the global fight against TB," said Trevor Mundel, President of the Global Health Program at the Bill & Melinda Gates Foundation. "Aeras' work will help realize the vision for the Decade of Vaccines, to create a world in which all individuals and communities enjoy lives free from vaccine-preventable diseases, through accelerated efforts from all partners. If donor and endemic countries can join together to show their commitment through funding and collaboration, the innovative research that Aeras and others are making possible could one day have a significant impact on TB, which is gaining in its ability to resist the solutions we have in hand. The foundation thanks Aeras for its commitment to the TB research and development space, helping us realize long-term goals sooner."

Once known as "consumption" for the slow wasting away of the people who died of it, tuberculosis is one of history's great global killers. It kills 1.4 million people every year, equivalent to the entire population of Munich, Germany or Phoenix, Arizona. One out of every three people globally is thought to be infected by the airborne TB organism, although only a portion will go on to develop the disease. And increasing cases of drug-resistant strains of TB, reported in 80 countries and 8 territories over the past several years, is one of the greatest global threats from TB today. A recent World Health Organization (WHO) study reports the highest-ever recorded levels of multi-drug resistant TB worldwide.

The WHO estimates the global economic burden of TB at nearly $12 billion a year, with India and China together accounting for more than half the global economic toll. London has the highest TB rate of any capital city in Western Europe, making it one of the city's biggest health problems today. And a new World Health Organization/European Union plan to address drug-resistant TB estimates18 percent of the global burden of resistant TB is in the European region. In the United States, just one case of extremely drug-resistant TB is estimated to cost a quarter-million dollars to treat.

In the last 12 years, TB vaccine research has made dramatic strides, but it began with a tremendous handicap. Scientists had learned little about the disease since the discovery of a vaccine in 1908 that continues to have limited efficacy. So in 2000, when scientists began in earnest to search for a new vaccine, they did so in the virtual dark.

"Until 20 or 30 years ago, the global community thought TB was on the way out, along with other killer infectious diseases like smallpox and polio," said Tom Evans, Chief Scientific Officer of Aeras. "But this lowering of the guard, and the emergence of drug-resistant strains and the deadly combination of TB and rising HIV infections in Africa, has created what the WHO called 'fire raging out of control' in developing countries. The disease should now have our full attention."

In the past decade, the number of TB vaccines in clinical trials has grown from zero to a dozen, six of which have been developed by Aeras or with support from Aeras and its partners. Two of these are currently the most clinically-advanced TB vaccine candidates in the world. Aeras scientists and their colleagues are applying what they've learned to rapidly test the best proposals coming out of laboratories around the world, in a drive to identify the most promising prospects for the next generation of vaccines.

Today's grant to Aeras will help advance several vaccine candidates into pivotal large-scale efficacy trials, build a robust and diverse pipeline of innovative, next-generation candidates, and develop and utilize key scientific approaches including challenge models, systems biology, and innovative vaccine designs to strengthen and accelerate TB vaccine development.

"Aeras is now at the center of the most promising research across private industry, government, and civil society, with the potential to deliver a vaccine by the end of this decade," said Aeras' Jim Connolly. "However, no single organization--including Aeras--can do this alone. We are in this together, and to succeed we will need to work with everyone--more investors, researchers, manufacturers, regulatory agencies, and national leaders."

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About Aeras

Aeras (www.aeras.org) is a non-profit product development organization dedicated to the development of effective TB vaccines and biologics to prevent TB across all age groups in an affordable and sustainable manner. Aeras utilizes its broad capabilities and technologies in collaboration with numerous partners and stakeholders to support the development of vaccines and other biopharmaceuticals to address TB and other significant public health needs of underserved populations. To date, Aeras has invented or supported the development of six TB vaccine candidates, which are undergoing Phase I and Phase II clinical testing in Africa, Asia, Europe and North America. Aeras receives funding from the Bill & Melinda Gates Foundation, other private foundations and various governments. Aeras is based in Rockville, Maryland, USA - where it operates a state-of-the-art manufacturing and laboratory facility - and Cape Town, South Africa.

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