Aeras

Aeras is a global nonprofit biotech with a mission to develop new tuberculosis vaccines that are affordable and accessible to all who need them.

Aeras has capabilities in finance, portfolio management, immunology, assay development, clinical trials, regulatory affairs and policy, advocacy and resource mobilization, as well as in-house capacity to conduct pilot manufacturing. Serving as a critical translational bridge from the bench to the field, Aeras has sponsored and conducted over 25 clinical vaccine trials enrolling thousands of subjects, and is a key partner in six active clinical development programs.

Aeras has approximately 160 employees, with offices in Rockville, Maryland; Cape Town, South Africa; and Beijing, China.

Mission

Aeras is a non-profit product development organization dedicated to the development of effective tuberculosis (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.

About TB

Tuberculosis is an airborne infectious disease that has existed for centuries, with evidence of the disease found in ancient Egyptian mummies. TB used to be called consumption, and in the 19th and 20th centuries was the leading cause of death in industrialized countries. Caused by a bacterial infection with M. tuberculosis, TB most commonly affects the lungs but can affect any organ in the body. The bacterium M. tuberculosis is present in a third of the world’s population - around 2 billion people. Although most will never become sick with the disease, 10 percent of those infected will develop active TB disease and will be able to spread the infection to others simply by coughing or sneezing. On average, a person with active TB will spread the disease to 10 to 15 people within a year. Symptoms of tuberculosis include coughing up blood, night sweats, weight loss and exhaustion.^[1]

Tuberculosis is especially dangerous to people with compromised immune systems. TB is the leading killer among those with HIV/AIDS, who are more susceptible to developing the disease. In South Africa, where there is a high burden of HIV/AIDS, the incidence of tuberculosis has increased 400 percent in the past 15 years. People with diabetes also have a higher risk of contracting TB, and when someone has both TB and diabetes, treatment for each disease is much more complicated.

Many people think of tuberculosis as a disease of the past, but the reality is that TB is an urgent public health crisis. According to the World Health Organization, 8.6 million people became sick with TB and 1.3 million people died of the disease in 2012.^[2] In fact, TB is the leading cause of death among people living with HIV, causing one out of every four deaths. It is also the third leading cause of death for women, affecting people during their most productive years (ages 15-44).

While control programs are making progress in reducing deaths from TB, global TB incidence relative to population growth has remained consistently high. There are almost 1 million more cases of TB in the world today (8.6 million) than in 1990 (7.8 million). And because of growing drug resistance, TB is becoming much more difficult and expensive to treat.

The Need for TB Vaccines

The most effective way to stop the global TB epidemic is to prevent the spread of M. tuberculosis, but that is becoming increasingly difficult with the rise of multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), the latter of which is resistant to most first- and second-line drugs. The WHO reports that MDR-TB cases are on the rise in most of the high disease burden countries, and XDR-TB has been identified in 92 countries.^[3] Another problem is the difficulty in identifying these types of TB. Despite progress in identifying cases of TB, the number of MDR-TB cases notified in 2012 was only 28% of the total estimated global MDR-TB cases. High disease burden countries like China especially struggle to report and treat MDR-TB, though other high MDR-TB burden countries such as India and South Africa have improved their detection rates over the past year.

Treating our way out of this epidemic is neither possible nor affordable for most countries, given the limitations inherent in the tools used today. The cost of treating MDR-TB is up to 200 times greater than the cost of treating drug-sensitive TB, often requiring up to two years of treatment, daily injections and in-patient care.^[4] The costs for scaling up and achieving universal access to MDR-TB and XDR-TB treatment and preventive therapy can prove logistically and economically prohibitive.

There is one vaccine, Bacille Calmette-Guérin (BCG), being used today to prevent TB in infants. But while BCG is the most widely used vaccine in the world, it has not successfully eliminated the disease due to its limited efficacy. Research and development for new vaccines would have the biggest impact on the epidemic, and remains the cornerstone to reaching global elimination within the coming decades.

The medical and research communities agree that new vaccines are central to future TB elimination programs. Like every other major infectious disease in the history of mankind, prevention through vaccination is expected to be the most cost-effective tool in eradicating and controlling TB. A new model incorporating data from 183 countries demonstrates that a partially efficacious (60 percent) adolescent and adult preventative vaccine, delivered to 20 percent of the target population, could potentially avert as many as 30-50 million new cases of TB by 2050. A significantly improved infant vaccine, over the 90-year-old Bacille Calmette-Guérin (BCG) vaccine, could potentially avert an additional 7-10 million new cases over that same period of time. New TB vaccines would be our single greatest preventative tool in the fight against TB, and without which TB will not be eradicated.^[5]

Finding a TB Vaccine

Since 2005, global investments of more than US $600 million have led to more than 15 TB vaccine candidates being tested in more than 50 human trials. In addition, promising activities for the development of new biomarkers have emerged. Today, the capacity exists for vaccine production to carry out large-scale clinical trials, particularly in disease endemic countries. There is also broad support for research within the communities where clinical trials are being conducted. For the first time in decades, basic information on safety and immune responses to a variety of first-generation TB vaccine candidates is available. The effectiveness of these vaccine candidates to prevent TB will be revealed over the next decade, and plans for regulatory approval and delivery of effective vaccines are being established.^[6]

Researchers around the world are developing tuberculosis vaccines in various stages of clinical development within the global vaccine pipeline. Aeras is involved in the development of six of the 13 vaccine candidates currently in clinical trials in Africa, Asia, North America and Europe. ^[7] ^[8]

Aeras works with partners to review and prioritize candidates using a stage-gating system. Aeras uses scientific approaches, including challenge models, systems biology and innovative vaccine designs to accelerate advancement of vaccine candidates.

The next phase of vaccine development will prove to be the most crucial. Limited resources - both financial and clinical - demand a structured and transparent "rational selection" process for advancing the most promising TB vaccine candidates. This cannot be the work of a single foundation or a small set of governments or biotech partners, but must involve the larger global public and private community.

Objectives

Aeras has three main objectives. First, to advance the world's leading TB vaccine candidates forward towards licensing and availability by reviewing data from clinical trials and selecting only the most promising candidates for large-scale Phase III trials. Second, to rationalize the TB vaccine development process by attempting to validate animal models and immunologic markers capable of predicting vaccine induced protection in humans, which will expedite development of more effective vaccines in the future. And third, to maintain a robust TB vaccine pipeline so that subsequent generations of better vaccines that prevent reactivation of latent infection will be brought forward.

Funding

Aeras’ research and development work is funded by key partners worldwide. Funding streams include grants from foundations and governments, investments from industry partners, and co-investments with other organizations, governments and institutions.

Donor support drives innovation by strengthening and advancing the global pipeline of new TB vaccines, accelerating efforts toward ensuring their availability to all who need them.

Aeras receives funding from a number of donors. In 2007, the Bill & Melinda Gates Foundation announced a $200 million grant to continue research for the next five years and has been a major donor since its inception. In 2012, Aeras received a grant from The Bill and Melinda Gates Foundation for up to $220 million over five years. ^[9] Other major donors include the Netherlands Ministry of Foreign Affairs, the UK Department for International Development, the Centers for Disease Control, the Danish International Development Agency, and the Japanese GHIT Fund.^[10]

References

External links

Aeras