2016 Annual Report

Message From our CEO

In March of 2016, a South African university student named Phumeza Tisile stood before policy makers and Members of Parliament in Bloemfontein and told her story: how she was diagnosed with extensively drug-resistant tuberculosis (XDR-TB) in the prime of her life; how she had to take 20 pills plus an injection every day, and eventually lost her hearing as a result; how she persevered in the face of what is often a death sentence, and became South Africa’s first female XDR-TB survivor. Phumeza asked the audience to open their eyes to the burgeoning TB crisis across the globe, and reminded them that we cannot end this epidemic without better drugs, innovative diagnostics and a new vaccine.

As I reflect on the past year, I can’t help but come back to Phumeza. Each and every one of our achievements – from building momentum in clinical and preclinical research, to setting new standards for community engagement at clinical sites—have been made with people like Phumeza in mind. A safe, effective TB vaccine could have saved Phumeza, her family and her community from so much suffering.

We don’t yet have the key to stopping TB. But Aeras will continue to fight for progress by learning as much as we can from our ongoing trials and research; by sharing scientific gains, building strong partnerships, and making sure that the world hears our call for increased and essential investment in TB vaccine research and development; and by leading the push for innovation, in the lab and beyond.

Many thanks to all of the partners, staff, donors and stakeholders who helped further TB vaccine research in 2016. There is still so much work to be done, but I look forward to meeting the challenges ahead together, with strength and ingenuity.

Sincerely,

Jacqueline E. Shea, PhD

Chief Executive Officer

Biography

Recognizing

A Growing Threat—But Also Opportunities For Progress

  • For the first time in recent history, surveillance data for 2015 showed that TB killed more people than any other infectious disease in the world. With 10.4 million new cases and 1.8 million deaths in 2015, TB was more deadly than Ebola, malaria, or even HIV.
  • We will not eliminate TB with the current tools available, especially with the growing threat of drug-resistant TB. In fact, the World Health Organization’s (WHO) End TB Strategy states that a new TB vaccine is key to ending the TB epidemic.
  • The highly anticipated Review on Antimicrobial Resistance (AMR), commissioned by the UK Prime Minister and led by economist Jim O’Neill, highlighted TB’s role in the overall global threat of AMR. If left unchecked, by 2050 AMR will kill 10 million people every year, and a quarter of those deaths will come from drug-resistant TB.
  • These statistics are staggering, but we know there is hope: A widely used, more effective TB vaccine would dramatically reduce the need for antibiotics and make a major impact on AMR control efforts.
  • There is tremendous opportunity ahead to build on recent scientific advances: Aeras has been focused on strengthening the global preclinical pipeline and developing much needed new tools. We are currently developing promising viral vector and whole cell vaccine candidates and improving models of disease in collaboration with our many valued development partners.

Building

Support to Solve a Global Crisis

  • The past year offered significant opportunity to raise awareness about the ongoing TB threat and how our work plays a critical role in the fight to end the epidemic. Our message was loud and clear: TB anywhere is TB everywhere, and the world simply cannot afford to neglect TB vaccine research efforts.
  • In the spring of 2016, Aeras partnered with other key stakeholders to bring 13 TB survivors to Washington, DC for more than 30 meetings with congressional representatives and staff in honor of World TB Day. This was the first time the TB community worked together for a coordinated advocacy event in Washington.
  • In July, Aeras was honored to present an overview of the importance of TB vaccine R&D at the launch of the African regional chapter of the Global TB Caucus, which includes Parliamentarians from 18 African countries.
  • At the 47th annual Union World Conference on Lung Health in Liverpool Aeras highlighted the urgent need for a new vaccine to end the TB epidemic. Events included our 2nd annual stakeholder luncheon, multiple presentations, an interactive Research Literacy zone, and an exhibit booth.
  • At the International AIDS Conference in Durban, South Africa, Aeras was proud to sponsor TB2016, a new pre-meeting to AIDS2016 designed to focus global attention on both TB and the HIV-TB co-epidemic. At the main conference we partnered with the International AIDS Vaccine Initiative to present a symposium on the important role of vaccine development in ending the HIV/AIDS and TB epidemics.

Advancing

Research Through Innovation and Collaboration

  • We will not end TB without bold ideas and strong partnerships. Our relationships, including those we build with researchers, stakeholders and the local community where clinical trials take place, are essential for progress. For instance, Aeras’s Community Engagement Program was a major focus in 2016, and included working with AVAC, clinical trial site staff, Community Advisory Boards, TB Alliance and TAG to draft Good Participatory Practice Guidelines for TB Vaccine Trials.
  • As part of this program, Aeras also worked hard to reach out to communities where clinical trials take place, using videos and print materials to build a better understanding of what happens during a clinical trial and why trials are so important.
  • Innovative ways to diversify the clinical pipeline and streamline research efforts continued throughout the year. Aeras focused on new approaches, such as novel vaccine vectors, and new tools, such as the Controlled Human Infection Model (CHIM).
  • A second ongoing Phase 2 trial (C-040) is the first prevention of established infection (POI) study to be conducted and is evaluating the ability of the H4:IC31 candidate vaccine and BCG revaccination to prevent sustained infection in 990 adolescents in South Africa. The C-040 trial completed primary analysis in June 2016, and received a recommendation from the DSMC to continue.
  • We expect results from these trials in the first half of 2018. This data represents an incredible learning opportunity and will provide important insights for Aeras, our partners and the TB vaccine research community at large.
  • The AerasSHARE Biorepository, launched in September 2016, allows investigators from the broader research community to access clinical specimens collected by Aeras and its research partners in an effort to facilitate state-of-the-art TB vaccine science and promote world-wide collaboration among researchers.
  • Planning has already started for the upcoming WHO Global Ministerial Conference on TB, where Aeras hopes to bring vaccine research to the forefront of discussion. Aeras is also gearing up for the 5th Global Forum on TB Vaccines, where stakeholders from around the world will gather to discuss strategies for advancement and share the latest in TB vaccine research findings.

Global Clinical Pipeline of TB Vaccine Candidates

Revised on September 26, 2017. Information is self-reported by vaccine sponsors.

2016 Financials

Aeras is committed to strong, effective stewardship of our funds in pursuit of our mission.

100 100 100 100 100 100 100 100 100 100
76 23 1 u
76 23 1 u
76 23 1 u
76 23 1 u
76 23 1 u
76 23 1 u

$33.5
million

  • Operating Revenue*

  • Bill & Melinda Gates Foundation Grant$28,100,000
  • Other Grant Revenue$5,471,726
  • Total Revenue$33,571,726
100 100 100 100 100 100 100 100 100 100
76 9 15 u
76 9 15 u
76 9 15 u
76 9 15 u
76 9 15 u
76 9 15 u
76 9 15 u
76 9 15 u

$34.4
million

  • Operating Expenses*

  • Total Vaccine Research Programs$24,728,630
  • External & Scientific Affairs$3,786,315
  • Support Services$5,902,091
  • Total Expenses$34,417,036

*Excludes revenues and expenses associated with administrative services and sublease of space to subtenant in Rockville, MD.

A special thanks to our Board, staff, partners, clinical trial participants and generous supporters.