OXFORD and LONDON, UK, and GAITHERSBURG, MD, USA I May 13, 2015 I A new phase 1 study has begun at the University of Oxford that will investigate the use of a modified vaccinia Ankara (MVA) Ebola Zaire vaccine candidate (MVA EBOZ) as a prime-boost to GSK’s Chimp Adenovirus type 3 (ChAd3) Ebola vaccine candidate. The study, being conducted by the clinical research group of Professor Adrian Hill of the Jenner Institute, has received regulatory approval to begin from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA).
The phase 1 study has a planned enrollment of 38 volunteers of which 6 will receive MVA EBOZ only while the other 32 will receive ChAd3-EBO-Z prime followed by MVA EBOZ boost.
Emergent BioSolutions (EBS) manufactured the supply of MVA EBOZ to be used in this phase 1 study, which is being conducted in the U.K. with support from the Wellcome Trust and the U.K. Department for International Development.
Professor Adrian Hill, Director of the Jenner Institute at Oxford University, said: “Production of the first ever batch of MVA for a clinical trial using a cell line is a milestone in the development of this important vaccine technology. This new process, which will allow very large scale production, will be of value not only for Ebola prevention, but also for a wide range of other disease indications including malaria and tuberculosis vaccination.”
Dr. Moncef Slaoui, Chairman of Vaccines, GSK, said: “We believe there is benefit in exploring different approaches such as a prime-boost strategy as we continue to develop our ChAd3 Ebola candidate vaccine. This ChAd3 Ebola candidate vaccine has shown encouraging immune responses and an acceptable safety and reactogenicity profile in ongoing phase 1 trials to date. Together, these different trials will provide important information about the vaccine and its potential to help combat this or future Ebola outbreaks.”
Daniel J. Abdun-Nabi, President and Chief Executive Officer of Emergent BioSolutions, said: “Emergent is pleased to be part of this collaboration by leveraging our unique capabilities to manufacture and supply MVA EBOZ for evaluation in this phase 1 clinical study. Our ability to quickly perform proof-of-concept work and manufacture MVA EBOZ at a 200L scale in an avian cell line is a result of our long-standing expertise in MVA-based vaccine development and manufacturing, fueled by our desire to have a positive, meaningful impact in finding a solution to this life-threatening disease.”
Oxford University’s Medical Sciences Division — one of the largest biomedical research centres in Europe, with over 2,500 people involved in research and more than 2,800 students. The University is rated the best in the world for medicine, and it is home to the UK’s top-ranked medical school. From the genetic and molecular basis of disease to the latest advances in neuroscience, Oxford is at the forefront of medical research. It has one of the largest clinical trial portfolios in the UK and great expertise in taking discoveries from the lab into the clinic. Partnerships with the local NHS Trusts enable patients to benefit from close links between medical research and healthcare delivery. A great strength of Oxford medicine is its long-standing network of clinical research units in Asia and Africa, enabling world-leading research on the most pressing global health challenges such as malaria, TB, HIV/AIDS and flu. Oxford is also renowned for its large-scale studies which examine the role of factors such as smoking, alcohol and diet on cancer, heart disease and other conditions. Please visit http://www.ox.ac.uk/.
GSK — one of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
Emergent BioSolutions — a global specialty biopharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats.
Emergent’s Bayview Campus in Baltimore, Maryland is a manufacturing facility equipped with disposable manufacturing technology such as single use bioreactors that enable production of viral and non-viral products with a quick turnaround. In this facility, Emergent has successfully manufactured product candidates for the company’s pipeline, including MVA-based vaccines.
SOURCE: Emergent BioSolutions
Post Views: 209
OXFORD and LONDON, UK, and GAITHERSBURG, MD, USA I May 13, 2015 I A new phase 1 study has begun at the University of Oxford that will investigate the use of a modified vaccinia Ankara (MVA) Ebola Zaire vaccine candidate (MVA EBOZ) as a prime-boost to GSK’s Chimp Adenovirus type 3 (ChAd3) Ebola vaccine candidate. The study, being conducted by the clinical research group of Professor Adrian Hill of the Jenner Institute, has received regulatory approval to begin from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA).
The phase 1 study has a planned enrollment of 38 volunteers of which 6 will receive MVA EBOZ only while the other 32 will receive ChAd3-EBO-Z prime followed by MVA EBOZ boost.
Emergent BioSolutions (EBS) manufactured the supply of MVA EBOZ to be used in this phase 1 study, which is being conducted in the U.K. with support from the Wellcome Trust and the U.K. Department for International Development.
Professor Adrian Hill, Director of the Jenner Institute at Oxford University, said: “Production of the first ever batch of MVA for a clinical trial using a cell line is a milestone in the development of this important vaccine technology. This new process, which will allow very large scale production, will be of value not only for Ebola prevention, but also for a wide range of other disease indications including malaria and tuberculosis vaccination.”
Dr. Moncef Slaoui, Chairman of Vaccines, GSK, said: “We believe there is benefit in exploring different approaches such as a prime-boost strategy as we continue to develop our ChAd3 Ebola candidate vaccine. This ChAd3 Ebola candidate vaccine has shown encouraging immune responses and an acceptable safety and reactogenicity profile in ongoing phase 1 trials to date. Together, these different trials will provide important information about the vaccine and its potential to help combat this or future Ebola outbreaks.”
Daniel J. Abdun-Nabi, President and Chief Executive Officer of Emergent BioSolutions, said: “Emergent is pleased to be part of this collaboration by leveraging our unique capabilities to manufacture and supply MVA EBOZ for evaluation in this phase 1 clinical study. Our ability to quickly perform proof-of-concept work and manufacture MVA EBOZ at a 200L scale in an avian cell line is a result of our long-standing expertise in MVA-based vaccine development and manufacturing, fueled by our desire to have a positive, meaningful impact in finding a solution to this life-threatening disease.”
Oxford University’s Medical Sciences Division — one of the largest biomedical research centres in Europe, with over 2,500 people involved in research and more than 2,800 students. The University is rated the best in the world for medicine, and it is home to the UK’s top-ranked medical school. From the genetic and molecular basis of disease to the latest advances in neuroscience, Oxford is at the forefront of medical research. It has one of the largest clinical trial portfolios in the UK and great expertise in taking discoveries from the lab into the clinic. Partnerships with the local NHS Trusts enable patients to benefit from close links between medical research and healthcare delivery. A great strength of Oxford medicine is its long-standing network of clinical research units in Asia and Africa, enabling world-leading research on the most pressing global health challenges such as malaria, TB, HIV/AIDS and flu. Oxford is also renowned for its large-scale studies which examine the role of factors such as smoking, alcohol and diet on cancer, heart disease and other conditions. Please visit http://www.ox.ac.uk/.
GSK — one of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
Emergent BioSolutions — a global specialty biopharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats.
Emergent’s Bayview Campus in Baltimore, Maryland is a manufacturing facility equipped with disposable manufacturing technology such as single use bioreactors that enable production of viral and non-viral products with a quick turnaround. In this facility, Emergent has successfully manufactured product candidates for the company’s pipeline, including MVA-based vaccines.
SOURCE: Emergent BioSolutions
Post Views: 209
