The University of Oxford and Emergent BioSolutions Inc. announced that they have formed a joint venture, The Oxford-Emergent Tuberculosis Consortium Ltd. (the "Consortium"), to further develop MVA85A, the world's most clinically advanced vaccine candidate for the prevention of tuberculosis. The University of Oxford, through its technology transfer office, Isis Innovation Limited, has exclusively licensed the MVA85A tuberculosis vaccine candidate and related technology to the Consortium.
The Consortium will work with the Aeras Global TB Vaccine Foundation to evaluate the efficacy of MVA85A in infants in a Phase IIb clinical trial anticipated to begin in 2009. The trial will take place at a clinical trial site developed by Aeras and the University of Cape Town's South African Tuberculosis Vaccine Initiative (SATVI) in Worcester, South Africa. The Consortium has secured GBP 8 million (approximately $16 million) from The Wellcome Trust and the Aeras Global TB Vaccine Foundation to fund this Phase IIb trial. Under agreements with the Consortium, Emergent BioSolutions has the rights to commercialize the MVA85A vaccine. The Aeras Global TB Vaccine Foundation will have distribution rights in the developing world to ensure availability and access to the vaccine to those who need it.
The MVA85A vaccine candidate is designed to work in tandem with the Bacille Calmette Guerin vaccine (BCG), which is currently the only available vaccine against tuberculosis. BCG is administered to infants throughout the developing world and in certain countries in the developed world. However, BCG provides only variable protection against pulmonary tuberculosis and is not effective in adults.
The MVA85A vaccine candidate is intended to augment the response of T-cells already primed by the BCG vaccine. Clinical trials to date have demonstrated consistently high cellular immune responses in those who received the MVA85A vaccine candidate following vaccination with BCG. The MVA85A vaccine has been awarded orphan drug status by EMEA and is the most clinically advanced of a new generation of tuberculosis vaccine candidates.
The MVA85A vaccine was originally developed at the University of Oxford by Dr. Helen McShane, a Wellcome Trust Senior Clinical Research Fellow, working with Dr. Sarah Gilbert and Professor Adrian Hill, a Wellcome Trust Principal Research Fellow. Further funding has been provided by the European Community's fifth and sixth Framework Programmes and the Medical Research Council (MRC), a UK organization dedicated to promoting the balanced development of medical and related biological research in the UK.
"I am excited by the prospect of further development of this promising vaccine candidate," said Dr. McShane of the University's Jenner Institute. "Curbing tuberculosis is a pressing global health priority, and if achieved could save the lives of millions. We at Oxford have selected Emergent BioSolutions as our commercial partner given their vaccine development experience and dedication to bringing lifesaving vaccines to market."
Mauro Gibellini, senior vice president corporate development, Emergent BioSolutions, said, "This unique public-private partnership provides Emergent BioSolutions with an extraordinary opportunity to address a major public health crisis. We believe that by pooling our resources and expertise with such distinguished academic and charitable peers, this consortium is well-positioned to develop what would be a groundbreaking vaccine to prevent one of the world's most widespread diseases and tragic causes of death."
Dr. Ted Bianco, Director of Technology Transfer at the Wellcome Trust, said, "We have been losing the battle against tuberculosis for too long, as a result of poor diagnostics, protracted treatment regimes, antibiotic resistance and HIV-induced, immuno-suppression. Conquering this historic enemy has to be one of our highest public health priorities, and developing an effective vaccine is arguably the key to a defensive strategy that will ultimately turn the tide in this insidious war. It is first class science that has brought us this new hope, and it will be first-class partnering that takes us to the next stage. I applaud Dr. McShane and her colleagues for their tireless efforts."
"New tuberculosis vaccines are urgently needed. A vaccine that is effective in all ages against all forms of the disease could have an enormous global public health impact by arresting the continued expansion of this terrible epidemic," said Jerald C. Sadoff, MD, the President and CEO of the Aeras Global TB Vaccine Foundation. "Leading scientists at the University of Oxford have been working on a novel vaccine candidate for infants and adolescents. I am encouraged by the support given to Oxford's efforts by The Wellcome Trust and Emergent BioSolutions," Dr. Sadoff said. "Aeras is pursuing this vaccine and other promising candidates. We will support MVA85A in expanded Phase II efficacy trials and in the use of Aeras-sponsored Phase III field sites if MVA85A meets all of the established criteria for such trials."
Emergent BioSolutions Inc. is a leading biopharmaceutical company dedicated to one simple mission--to protect life. We develop, manufacture and commercialize vaccines and therapeutics that assist the body's immune system to prevent or treat disease.
Oxford University's Medical Sciences Division is one of the largest biomedical research centres in Europe. It represents almost one-third of Oxford University's income and expenditure, and two-thirds of its external research income.
The Wellcome Trust is the largest charity in the UK. It's mission is to fund innovative biomedical research, in the UK and internationally, spending around GBP 600 million each year to support the brightest scientists with the best ideas.
The Aeras Global TB Vaccine Foundation (http://www.aeras.org) is a non-profit organization working as a Product Development Partnership to develop new tuberculosis vaccines and ensure that they are distributed to all who need them around the world.
The South African Tuberculosis Vaccine Initiative is located in the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town (UCT). Since 1999, with funding largely from the Aeras Global TB Vaccine Foundation, SATVI has developed the capacity to conduct registration standard vaccine trials at a site in Worcester, where rates of tuberculosis are amongst the highest in the world.