- Emergent has completed proof-of concept manufacturing of an MVA Ebola Zaire vaccine candidate anticipated for use in a Phase 1 clinical study in the UK
- 200L scale production leverages Emergent's unique expertise and capabilities in MVA-based vaccine product development and manufacturing
GAITHERSBURG, Md., March 16, 2015 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that, under several agreements signed with the University of Oxford, GSK, and the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) respectively, it has manufactured a modified vaccinia Ankara (MVA) Ebola Zaire vaccine candidate (MVA EBOZ) anticipated for use in a Phase 1 clinical study to be conducted by Professor Adrian Hill of the Jenner Institute. This clinical trial is being supported by a grant from the Wellcome Trust and the UK Department for International Development. The study, which will be conducted in the UK, will evaluate the safety of MVA EBOZ as a heterologous boost to GSK's Chimp Adenovirus type 3 (ChAd3) Ebola vaccine candidate. Data from an Ebola vaccine human clinical trial published recently in the New England Journal of Medicine suggest the use of an MVA vector as a potential option to boost the levels of ChAd-primed antibody and T-cell responses.
Under these agreements, Emergent performed proof of concept work and manufactured the MVA EBOZ vaccine candidate at a 200L scale in an avian cell line, which had previously been licensed to the company. Manufacturing in this cell line has significant advantages including removing the requirement for eggs from the manufacturing process, consistency of manufactured vaccine lots, and increases in doses delivered. Manufacturing of the first clinical lot of the MVA EBOZ vaccine candidate is now complete and is undergoing acceptability and release testing. The scalable process has the potential to meet the demand for multi-million doses in a few months.
"Emergent is pleased to be collaborating with the Jenner Institute, Oxford University, NIAID, and GSK to advance this MVA EBOZ vaccine candidate into a Phase 1 study," said Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions. "Emergent is well-positioned for this unique opportunity given our long standing expertise in MVA product development and our MVA manufacturing capabilities utilizing a proprietary avian cell line to which we hold rights. This is the first time an MVA EBOZ vaccine candidate has been produced at a 200L scale in an avian cell line and we look forward to continuing this collaborative effort to address this public health threat."
Emergent manufactured the MVA EBOZ vaccine candidate at its Bayview Campus, Baltimore, Maryland manufacturing facility, which is 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. This facility has also been designated by the U.S. Department of Health and Human Services as a Center for Innovation in Advanced Development and Manufacturing (CIADM) that helps facilitate advanced development and surge manufacturing of medical countermeasures to address public health threats.
About Emergent BioSolutions
Emergent BioSolutions is 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. Additional information about the company may be found at www.emergentbiosolutions.com. Follow us @emergentbiosolu.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, prospects, plans and objectives of management, and any other statements containing the words "believes", "expects", "anticipates", "intends", "plans", "estimates" and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including the success of our ongoing and planned preclinical studies and clinical trials; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; and our commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.
Robert G. Burrows
Vice President, Investor Relations
Vice President, Global Public Affairs and