Annual Report 2014

to explore our work this year

Aeras’s mission of pursuing affordable and globally effective vaccines for tuberculosis (TB) is at the core of everything we do. That is because each of us at Aeras is keenly aware of the tremendous toll TB takes on the world, causing 4100 deaths every day.

Achieving this mission requires a multifaceted approach, guided by our strategic imperatives and founded upon global partnerships. Aeras is committed to strengthening our relationships with stakeholders and seeking out new collaborations with academic institutions, nonprofit organizations, pharmaceutical and biotech companies, and governments that can bolster our work with scientific expertise, technology, resources and funding. We must develop a more diverse and robust portfolio of vaccine candidates using time- and resource-efficient strategies. We also must raise awareness that more than 2 billion people—one-third of the world’s population—are infected with Mycobacterium tuberculosis (M.tb.), the bacteria that cause TB, culminating in 9 million new cases of TB and 1.5 million deaths each year.

In 2014, we made great progress on these fronts. Aeras and GlaxoSmithKline (GSK) initiated a large Phase 2b clinical trial of our most advanced vaccine candidate, M72/AS01E, to assess its ability to prevent TB in high-risk adults. Such a vaccine could have a rapid and dramatic impact because adolescents and adults are the major transmitters of TB and bear the majority of the burden of the disease. Even with an efficacy rate of just 60 percent with a 10-year duration of protection, M72/AS01E delivered to just 20 percent of adults and adolescents globally could prevent approximately 50 million cases of TB in its first 25 years of use. By interrupting transmission, this vaccine could potentially prevent more TB in young children than the same vaccine delivered as a boost to BCG in newborns, and do so in a cost-effective manner, as suggested in a study published last year in the Proceedings of the National Academy of Sciences.

Other accomplishments include the launching of a novel Proof of Concept, Prevention of Infection trial of the H4:IC31 vaccine or BCG revaccination in adolescents in South Africa, in collaboration with Sanofi Pasteur; managing consortia to develop a human challenge model of TB and to assess the potential for antibody-based vaccines; and achieving promising results from several vaccine studies in an enhanced nonhuman primate model. Aeras also co-sponsored three major international workshops to address key scientific issues: aerosol delivery of TB vaccines, Whole Mycobacterial Cell Vaccines, and TB vaccine development to prevent M.tb. Infection.

Aeras continues to raise awareness of the threat of TB through our award-winning documentary films, websites, social media efforts and media outreach. This past year we were encouraged by President Obama’s executive order that directs the U.S. Department of Health and Human Services and other relevant agencies to increase resources toward combating drug-resistant diseases, including TB. This initiative will raise the profile of drug-resistant TB, which sickened more than 480,000 people worldwide in 2013, and optimally result in greater emphasis to counter this problem, including support for TB vaccine development.

We are encouraged by progress in 2014 and are grateful for the support of our many partners and collaborators. We firmly believe that together we can achieve our shared goal of eradicating TB as a global health emergency.

Thank you,

Thomas G. Evans, M.D., Chief Executive Officer
Ann M. Ginsberg, M.D., Ph.D., Chief Medical Officer
Jacqueline E. Shea, Ph.D., Chief Operating Officer
Aeras Executive Team

Research & Development

Portfolio Management

Targeting resources towards the most promising candidates from a portfolio of options is critical to achieving our ultimate goal of developing a universally available and effective TB vaccine. Created with the help of a wide range of partners and stakeholders over the last few years, our portfolio management process is transparent, data-driven and based on rigorous science. A dedicated team reviews all internal and external candidates according to predetermined criteria that include novelty, superiority, technical feasibility and expected safety. The Aeras Portfolio Review Committee then uses these recommendations to create and manage a diverse portfolio of candidates and concept-driven studies to maximize probability of success.

Preclinical Highlights

Aeras and its partners are pursuing a wide variety of new antigens, models, assays, adjuvants, platforms, and routes of delivery at the preclinical stage of research:

  • Aerosol Delivery

    Aeras is working with several partners to explore this promising vaccine delivery method to enhance mucosal immunity. Aeras and CREATE Vaccine Company, Ltd. are working together to develop new mucosal TB vaccines based on the National Institute of Biomedical Innovation, Health, and Nutrution’s (NIBIOHN) human parainfluenza type-2 (rhPIV2) vector technology. Aeras is also collaborating with researchers at the University of Pittsburgh and Wuhan University in China to evaluate aerosol delivery of vaccines in nonhuman primates. In April 2014, Aeras and the National Institute of Allergy and Infectious Diseases convened a workshop on aerosol TB vaccines, drawing expertise from Europe, China, Canada, South Africa and the United States.

  • Cytomegalovirus-based Vaccines

    The Oregon Health & Science University (OHSU) and associated Vaccine and Gene Institute is leading a collaboration with Aeras and the Bill & Melinda Gates Foundation (BMGF) to develop a promising TB vaccine candidate using a cytomegalovirus (CMV) backbone that induces novel immunologic responses and has shown promise in initial non-human primate studies.

  • Accelerating New Discovery

    Aeras is collaborating with a large number of academic and biotechnology partners to develop a “natural” transmission model in animals, which can then be used to evaluate vaccine candidates that may work through antibody or other immunologic mechanisms different from those induced by most vaccines presently being tested in the clinic.

  • Novel Adjuvanted Protein

    Aeras, INSERM and the TuBerculosis Vaccine Initiative (TBVI) jointly advanced development of a new adjuvanted recombinant protein candidate, heparin binding hemagglutinin antigen (HBHA), with a unique mechanism of action. Further studies, including detailed product characterization and functional investigations, were undertaken in 2014, along with process development to create a final cGMP manufacturing process in anticipation of going to first-in-man studies.

  • Accelerating New Tools

    Aeras works with partners to develop novel BCG and TB strains that might be used in developing human challenge models, and supplies reagents and standardized antigen cassettes to be used in discovery programs throughout the world. A consortium to standardize a functional readout to measure vaccine efficacy, the mycobacterial growth inhibition assay (MGIA), continues in efforts to find better correlates of protection.

Aeras’s Clinical and Epidemiological Studies Map

Aeras Clinical Trials and Epidemiological Studies Map

Global TB Vaccine Pipeline

Global TB Vaccine Pipeline

Aeras Clinical Trials in 2014: Highlights

Proof of Concept: Prevention of Disease

Aeras and GlaxoSmithKline Vaccines (GSK) initiated in 2014 a large, multi-country, Phase 2b clinical trial of GSK’s proprietary protein-adjuvant vaccine candidate M72/AS01E. This candidate has already been extensively evaluated in early human and animal studies and is now being assessed in the clinic for its ability to prevent TB in healthy adults. The study is enrolling more than 3,500 healthy adults between the ages of 18 and 50 with latent TB infection who live in South Africa, Kenya and Zambia. Ten percent of subjects were successfully enrolled by the end of 2014, ahead of the targeted recruitment rate. Results of this double-blind, randomized, placebo-controlled study are expected to be available in 2018.

Proof of Concept: Prevention of Infection

A groundbreaking Phase 2 clinical trial of the TB vaccine candidate H4:IC31 and of BCG revaccination is currently underway in South Africa. With Aeras as the regulatory sponsor and conducted by the South African Tuberculosis Vaccine Initiative (SATVI), this is the first study to evaluate, as a proof of concept, that the H4:IC31 vaccine has important biological activity in humans and has the ability to prevent sustained infection by M.tb. (the bacteria that cause TB). Studies that measure the prevention of TB disease typically are larger, longer and more expensive than this study of 990 healthy adolescents, which will provide quicker results with fewer subjects. If a vaccine demonstrates the ability to prevent sustained M.tb. infection, it indicates a high probability of success that it will be able to prevent disease and ultimately break the cycle of transmission.

Portfolio Management in Action: MVA Ag85A and Crucell Ad35/Aeras 402

A large study of the safety and immunogenicity of the MVA Ag85A vaccine was undertaken in almost 2800 infants over the past 4 years, and the results reported in Lancet Infectious Diseases in early 2015. Although the vaccine did not show any greater efficacy than BCG alone, the field learned important lessons from this study and correlates of risk are being discovered. The trial results also led to the downsizing of a second trial of the same vaccine - in HIV+ adults, enabling redirection of resources and minimizing subject enrollment.

Also in 2014, we completed the first large trial of an adenoviral-based vaccine in over 400 infants. An adaptive trial design enabled us to choose not to expand the trial to enter the efficacy phase when the vaccine did not meet pre-specified immunogenicity criteria. We also supported a critical study of the combination of these two vaccines in adults, and showed that the combined use of an adenoviral-based vaccine followed by an MVA-based vaccine was safe and resulted in more robust immunologic responses than seen with either vaccine alone. This exciting result sets the stage for future evaluation of combination vaccine approaches in animals and man.

Studies Started in 2014:

Continuing Studies:

 

Hot Topic Scientific Conferences

Aeras co-sponsored three major international workshops to address key scientific issues:

Aerosol Delivery of TB Vaccine

Aeras and the National Institute of Allergy and Infectious Diseases held this workshop in Bethesda, Maryland, in April to explore the potential for developing aerosol vaccines capable of preventing M.tb. infection or active TB disease, or as immunotherapy for persons with active TB. Members of the workshop emphasized the need for greater support to further explore the potential of this delivery methodology, either alone or as an adjunct to traditional parenteral methods of vaccine administration.

Whole mycobacterial cell vaccine

Aeras and the Max Planck Institute for Infection Biology convened this workshop in Berlin in July, to discuss progress in the development of TB vaccines based on whole mycobacteria cells. Workshop participants concurred that the use of whole mycobacteria cells as TB vaccine candidates merits greater support, particularly given the limited understanding of the specific M.tb. antigens necessary to generate an immune response capable of preventing M.tb. infection.

TB Vaccine Development to Prevent M.tb. infection

Aeras and the National Institute of Allergy and Infectious Diseases held this conference in Rockville, Maryland, in November, to explore the biologic plausibility, potential public health and economic impact, and regulatory feasibility in attempting to develop a vaccine to prevent sustained infection with M.tb. Pursuing a prevention of sustained M.tb. infection indication for TB vaccines, in parallel with ongoing efforts to develop vaccines to prevent active TB disease, was deemed a potentially important effort, but would require further resources, particularly to improve diagnostic assays, to increase the regulatory feasibility of this endeavor.

Scientific Articles

Aeras scientists contributed to advancing the field by authoring numerous articles published by scientific journals in 2014.

 

Global Reach

About Us

Aeras is a nonprofit, global biotech advancing the development of new TB vaccines for the world, in partnership with other biotech, pharmaceutical, governmental and academic organizations. With offices in the U.S., Africa, and Asia, Aeras represents a widely recognized critical mass of expertise in TB and vaccine development, and functions as a “translational machine” to ensure critical scientific findings are developed into vaccine products to prevent TB. Working with our extensive network of partners and funders, we can effectively manage and prioritize vaccine candidates to accelerate progress in TB vaccine research and development. As a nonprofit we develop and champion TB vaccines based on global need and science, rather than profit, and we work to ensure that the final product is affordable and accessible to those living in the developing world where TB vaccines are most needed.

Strategic Imperatives

In addition to our mission, Aeras is guided by these six strategic imperatives:

  • Moving the most promising vaccine candidates through to registration and market access.
  • Using translational and experimental medicine studies to de-risk candidates at an earlier and less costly stage of development.
  • Developing new and improved human challenge and animal models of disease and utilizing findings from basic research to inform correlates of protection and accelerate development.
  • Diversifying the pipeline through innovation and selecting the best vaccine candidates in each class.
  • Expanding and diversifying the funding base to support TB vaccine development.
  • Strengthening our partnerships and organization to enable TB vaccine development.

2014 Financials

  • Revenue

  • Contributions from Foundations$ 37,888,593
  • Government Grants$ 11,716,640
  • Investment Income$ 75,830
  • Total Revenue$ 49,681,063
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
76 23 1 u
76 23 1 u

$49
million

  • Expenses

  • Total Vaccine Research Programs$ 32,793,000
  • External Affairs$ 3,739,642
  • Support Services$ 6,695,132
  • Total Expenses$ 43,227,774
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

$43
million

  • Discontinued Operations*

  • Discontinued Operations$ 12,475,434

*Discontinued Operations reflect the net financial results of the Aeras Contract Manufacturing and Process Development operations which were sold in 2015 and no longer operated by Aeras effective June 2015.

  • Net Assets

  • Change in Net Assets$ -6,142,475
  • Net Assets - Beginning of Year$ 43,039,555
  • Net Assets - End of Year$ 36,897,080

Aeras is grateful to the leaders who contributed to the strength of the organization in 2014.

2014 Board of Directors

Learn More
  • Lota S. Zoth, CPA

    Lota S. Zoth, CPA (Ret)

    Board Chair
    Former Senior VP
    and CFO of MedImmune, Inc.

  • Barry Bloom, PhD

    Barry Bloom, PhD

    Distinguished Service Professor at Harvard University
    and Joan L. and Julius H. Jacobson Professor of Public Health

  • James Connolly

    James Connolly

    Former President & CEO of Aeras

  • Marja Esveld, MSc

    Marja Esveld, MSc

    Senior Advisor, Research and Innovation
    Ministry of Health, The Netherlands

  • Thomas G. Evans, MD

    Thomas G. Evans, MD

    CEO of Aeras

  • Peter Barton Hutt

    Peter Barton Hutt

    Senior Counsel,
    Covington & Burling,
    and Lecturer, Harvard Law School

  • Marian Jacobs

    Marian Jacobs

    Former Dean and Emeritus Professor of Paediatrics & Child Health Faculty of Sciences,
    University of Cape Town

  • Michel Kazatchkine

    Michel Kazatchkine

    UN Secretary-General’s Special Envoy on HIV/AIDS in Eastern Europe and Central Asia

  • Wayne Pisano

    Wayne Pisano

    President and CEO of Vaxinnate

  • Regina Rabinovich, MD, MPH

    Regina Rabinovich, M.D, M.P.H.

    ExxonMobil Malaria Scholar in Residence, Harvard School of Public Health

  • Gerd Zettlmeissl, PhD

    Gerd Zettlmeissl, Ph.D

    Former CEO of Intercell AG

2014 Senior Leadership

Learn More
  • Thomas G. Evans, MD

    Thomas G. Evans, MD

    Chief Executive officer

  • Ann M. Ginsberg, MD, PhD

    Ann M. Ginsberg, MD, PhD

    Chief Medical Officer

  • Jacqueline Shea, PhD

    Jacqueline Shea, PhD

    Chief Operating Officer

  • Wendy Penry

    Wendy Penry

    Chief Human Resources Officer

  • Daniel Rezikov

    Chief Financial Officer

  • Kevin Sly

    Kevin Sly

    Vice President,
    Business & Corporate Development

  • Dereck Tait, MB, ChB

    Dereck Tait, MB, ChB

    Director,
    Clinical Development South Africa

  • Barry Walker, PhD

    Barry Walker, PhD

    Senior Director,
    Preclinical Development

  • Rita Khanna, PhD, JD

    Rita Khanna, PhD, JD

    General Counsel

  • Lew Schrager, MD

    Lew Schrager, MD

    Vice President,
    Science Affairs

  • Eric Tsao, PhD

    Eric Tsao, PhD

    VP of Technical Operations

Advisory Groups

Vaccine Advisory Committee
Aeras’s Vaccine Advisory Committee (VAC) provides external expert advice on criteria for vaccine candidate selection, preclinical stage-gating, and priorities for advancing candidates in preclinical and clinical portfolios. The VAC, which meets at least twice a year, advises Aeras on a broad range of crucial product development issues including: development plans, regulatory strategy, epidemiology studies, innovative clinical trial designs and downstream market considerations.

  • Marcel Behr, MD

    Professor of Medicine
    Division of Infectious Diseases & Medical Microbiology
    McGill University Health Centre

  • Ralf Clemens, MD, PhD

    Head, Takeda Development
    Takeda Pharmaceuticals

  • Patricia E. Fast, MD PhD

    Chief Medical Officer
    IAVI

  • Barney S. Graham, MD, PhD

    Senior Investigator
    Chief, Clinical Trials Core
    Chief, Viral Pathogenesis Laboratory
    Vaccine Research Center, NIAID, NIH

  • Peggy Johnston

    HIV & TB Team
    Bill & Melinda Gates Foundation

  • Rino Rappuoli, PhD

    Global Head, Vaccines Research
    Novartis Vaccines & Diagnostics

  • Robin Wood, MD, DSc (Med)

    Director & Principal Investigator
    Desmond Tutu HIV Centre
    Institute of Infectious Disease, University of Cape Town

  • Douglas Young, MD

    Fleming Professor of Medical Microbiology
    Imperial College London, and
    Head of Division of Mycobacterial Research
    MRC National Institute for Medical Research

  • Ann M. Ginsberg, MD, PhD – Secretariat

    Chief Medical Officer
    Aeras

Biomarkers and Correlates Working Group
The Biomarkers and Correlates Working Group (BCWG) reviews progress in the field of correlates and biomarkers, including gaps and new developments in the field. The group also helps design Aeras studies and advises on funding needs.

  • Alan Aderem, PhD

    President and Director
    Seattle Biomedical Research Institute
    Seattle BioMed

  • Christopher Wilson, MD

    Director
    Bill & Melinda Gates Foundation
    Seattle, USA

  • Alan Sher, PhD

    Chief, Laboratory of Parasitic Diseases
    National Institute of Allergy and Infectious Diseases (NIAID)

  • Christine Sizemore, PhD

    Chief of the Tuberculosis, Leprosy and other Mycobacterial Diseases Section within the Respiratory Diseases Branch of the Division of Microbiology and Infectious Diseases (DMID) National Institute of Allergy and Infectious Diseases (NIAID)

  • Lewis Schrager, MD

    Vice President, Scientific Affairs
    Aeras

  • JoAnne Flynn, PhD (Chair)

    Associate Professor, Department of Molecular Genetics and Biochemistry
    University of Pittsburgh School of Medicine

  • Professor Glyn Hewinson

    Head, TB Research Group
    Veterinary Laboratories Agency

  • Willem Hanekom, MBChB

    Deputy Director, TB Vaccines
    Bill & Melinda Gates Foundation

  • Christopher Karp

    Deputy Director, Global Health Discovery & Translational Sciences Program
    Bill & Melinda Gates Foundation

  • Stefan H. E. Kaufmann, PhD

    Director of the Department of Immunology
    Max Planck Institute for Infection Biology

  • Tom H. M. Ottenhoff, MD, PhD

    Professor in Immunology
    Head group Immunology and Immunogenetics of Bacterial Infectious Diseases
    Dept. of Infectious Diseases
    Leiden University Medical Center

  • Thomas J. Scriba, PhD

    Associate Professor and Deputy Director, Immunology
    South African TB Vaccine Initative
    University of Cape Town

Major Donors and R&D Partners

Aeras’s successes are only possible through collaborations and partnerships. Aeras gratefully acknowledges these important donors and R&D partners, along with the numerous other collaborators, including clinical trial participants and site staff, not listed here that make our work possible:

Academic Institutions

  • Albert Einstein College of Medicine
  • Colorado State University
  • Cornell University
  • Dartmouth University
  • Fudan University
  • Harvard University
  • Imperial College London
  • Johns Hopkins University
  • London School of Hygiene & Tropical Medicine
  • Maastricht University
  • Oregon Health & Science University
  • University of Oxford
  • Pontificia Universidad Catolica de Chile
  • Rutgers University
  • St. Louis University
  • Tulane University
  • University of California, Los Angeles
  • University of California, Berkeley
  • University of Alberta
  • University of British Columbia
  • University of Cape Town
  • University of Maryland
  • University of Pittsburgh
  • University of Sydney
  • University of Wales
  • Wuhan University
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