Emergent Signs Agreements with Oxford University, GSK, and NIAID

Emergent BioSolutions Inc. has 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.