Partnership of non-profits, pharmaceutical companies could yield major health, economic impacts worldwide                                                                                                     

WASHINGTON, D.C. — September 16, 2014 — The Sabin Vaccine Institute (Sabin) today announced that its product development partnership (Sabin PDP) received $2 million from the Global Health Innovative Technology Fund (GHIT Fund) to develop a new therapeutic vaccine formulation for Chagas disease. Baylor College of Medicine, Eisai Co., Ltd. (Eisai) and Aeras are partnering on this project with the Sabin PDP, based at the Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development in Houston, Texas.

“New tools for Chagas disease are desperately needed, especially ones that are safe and effective for pregnant women and children. We are eager to begin working towards a successful, cost-effective therapeutic vaccine, a tool that offers tremendous promise for saving lives and treating all vulnerable populations,” said Peter Hotez, MD, PhD, president of Sabin, director of the Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine. “An achievement of this kind could also transform the entire field of vaccinology for neglected tropical diseases (NTDs) and help address several Millennium Development Goals (MDGs).”

This two-year preclinical study will use a favorable protein-based antigen (Tc24) formulated with a novel TLR4 agonist adjuvant (E6020) developed by Eisai to elicit a stronger and more effective immune response compared to conventional aluminum-based adjuvant formulations. Protein-based vaccines are best positioned for clinical translation because of their excellent safety record, history of advancing to licensure and ability to produce protective immunity in humans.

“Eisai is pleased to contribute with formulation expertise and with the vaccine adjuvant E6020 to this important initiative as part of its existing collaboration with the Sabin PDP to reduce the widespread suffering caused by Chagas disease,” said Takashi Owa, PhD, chief innovation officer of Eisai. “As an original signatory to the 2012 London Declaration on NTDs, Eisai is a committed partner in the fight against NTDs and seeks to expand access among the world’s poorest people to essential, life-saving interventions.”

The Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development, led by faculty at Baylor College of Medicine, will lead on process development optimization and scale up, and on formulation and characterization studies, including preclinical evaluation for the selected vaccine targets. Aeras’ manufacturing unit will reproduce the technology and process development and scale-up activities for the partnership.

Ultimately, a therapeutic vaccine could solve current challenges of drugs used to combat Chagas disease, including high toxicities, prolonged treatment regimens, low efficacy in preventing severe cardiac complications and contraindication in pregnancy.

“We are proud to help pave the way for urgently needed vaccines and drugs that could potentially save hundreds of thousands of lives,” said BT Slingsby, MD, PhD, MPH, CEO and executive director of the GHIT Fund. “These exciting technologies are great advances that could be game-changers for diseases that claim too many lives and keep vast areas of our world in poor health and poverty.”

Chagas disease is an NTD estimated to infect 7.5 million people and cause more than seven billion dollars in annual economic losses globally. Chronic Chagas cardiomyopathy, present in approximately 30 percent of those infected with Chagas disease, causes arrhythmias, aneurysms, heart failure and sudden death. The T. cruzi parasite, which causes Chagas disease, is present in approximately 11 percent of pregnant women in Latin America and 40,000 women in North America and Japan at any given time, and between five to 10 percent of those pregnant women pass the infection to their unborn fetus.

 

Chagas disease is predominantly found in North America and Europe, but a few thousand cases have appeared in Japan. In the Latin America region, based on disability adjusted life years (DALYs), the burden of Chagas disease is five times greater than malaria.

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About The Sabin Vaccine Institute and the Sabin Vaccine Institute Product Development Partnership

The Sabin Vaccine Institute (Sabin) is a non-profit, 501(c)(3) organization dedicated to reducing needless human suffering from vaccine-preventable and neglected tropical diseases (NTDs) worldwide. Sabin develops new vaccines, advocates for increased use of existing vaccines and promotes expanded access to affordable medical treatments in collaboration with governments, academic institutions, scientists, medical professionals and non-profit organizations. For more information please visit www.sabin.org.

Sabin’s research and development of new vaccines is conducted through a collaboration called the Sabin Vaccine Institute Product Development Partnership (Sabin PDP), which is based at the Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development, led by faculty at Baylor College of Medicine, works with leading private, academic and public institutions around the world to develop and test safe, effective and low-cost vaccines that benefit the world’s poorest communities. A complete overview of ongoing projects and partners is available at www.sabin.org/pdp.

About the GHIT Fund

The GHIT Fund is a public-private partnership between five Japanese pharmaceutical companies, two Japanese government ministries and the Bill & Melinda Gates Foundation. Launched in April 2013 with US$100 million in funding, the organization taps Japanese R&D to fight neglected diseases. It is the first fund to involve a consortium of pharmaceutical companies, government and civil society working together to support research and development for neglected diseases. www.ghitfund.org/en

About Aeras

Aeras is a nonprofit biotech advancing the development of tuberculosis vaccines for the world. In collaboration with global partners in Africa, Asia, North America and Europe, Aeras is supporting the clinical testing of six experimental vaccines as well as a robust portfolio of earlier stage candidates. Aeras receives funding from the Bill & Melinda Gates Foundation, the UK Department for International Development, the Netherlands’ Ministry of Foreign Affairs, Australian AID, and a range of other governments. Aeras is based in Rockville, Maryland; Cape Town, South Africa; and Beijing, China. www.aeras.org.

About Baylor College of Medicine

Baylor College of Medicine (www.bcm.edu) in Houston is recognized as a premier academic health sciences center and is known for excellence in education, research and patient care. It is ranked 21st among medical schools for research and 12th for primary care by U.S. News & World Report. Baylor is listed 19th among all U.S. medical schools for National Institutes of Health funding and number one in Texas. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates CHI St. Luke’s Baylor St. Luke’s Medical Center. Currently, Baylor trains more than 3,000 medical, graduate, nurse anesthesia, physician assistant and orthotics students, as well as residents and post-doctoral fellows. Follow Baylor College of Medicine on Facebook (http://www.facebook.com/BaylorCollegeOfMedicine) and Twitter (http://twitter.com/BCMHouston).

About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Oncology and Neurology.  As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.  For more information about Eisai Co., Ltd., please visit http://www.eisai.com/

About Texas Childrens Hospital

Texas Children’s Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children’s hospital in Texas, and among the top in the nation, Texas Children’s has garnered widespread recognition for its expertise and breakthroughs in pediatric and women’s health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Center for pediatric research; Texas Children’s Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children’s Hospital West Campus, a community hospital in suburban West Houston; and Texas Children’s Hospital The Woodlands, a second community hospital planned to open in 2017. The organization also created the nation’s first HMO for children, has the largest pediatric primary care network in the country and a global health program that’s channeling care to children and women all over the world. Texas Children’s Hospital is affiliated with Baylor College of Medicine. For more information, go to www.texaschildrens.org. Get the latest news by visiting the online newsroom and Twitter at twitter.com/texaschildrens.

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