The University of Oxford and Emergent BioSolutions said last week that they have formed a joint venture, the Oxford-Emergent Tuberculosis Consortium, to further develop a TB vaccine candidate originally discovered by Oxford researchers.
As part of the arrangement, which will eventually seek to produce and sell about 100 million doses of the vaccine per year to the developing world at costs of less than $2 per dose, Isis Innovation Limited, the technology-transfer company of Oxford University, has granted the consortium an exclusive license for the vaccine candidate and related technology.
In addition, the Wellcome Trust and the Aeras Global TB Vaccine Foundation have agreed to fund the consortium with £8 million (about $16 million) to support a Phase IIb clinical trial for the vaccine, expected to commence in 2009.
The trial will take place at a clinical trial site that Aeras has developed over the past several years in Worcester, South Africa, as part of a partnership with the University of Cape Town’s South Africa Tuberculosis Vaccine Initiative.
In exchange, Aeras will receive rights to distribute the vaccine in the developing world – mainly India, China, and African nations – where it will be made available at a reduced cost. Emergent will retain rights to commercialize the vaccine in all other parts of the world, according to the deal.
“We provide the extensive resources that we have put into our field sites to develop a place where we can do a test of concept [and] prove that it works, then do Phase III field trials to get licensure,” Aeras Global TB Vaccine Foundation CEO Jerald Sadoff told BTW this week. “In return for that, we get the right to purchase the vaccine from the joint venture at a very low cost, which we can then use for distribution for the developing world.”
Financial terms of the licensing agreements between Isis, the consortium, Wellcome, and Aeras have not been disclosed.
The vaccine, MVA85A, was originally developed at the University of Oxford by Helen McShane, a Wellcome Trust senior clinical research fellow; molecular virologist Sarah Gilbert; and Adrian Hill, a professor of human genetics and a Wellcome Trust principal research fellow.
The vaccine is designed to work in tandem with the Bacille Calmette-Guérin vaccine, which is currently the only available vaccine against TB. According to the consortium, BCG is administered to infants both in the developing and developed world, but only provides variable protection against pulmonary TB. It is not effective in adults.
The MVA85A vaccine candidate is designed to augment the response of T-cells already primed by the BCG vaccine, according to the consortium. Thus far, clinical trials have demonstrated consistently high cellular immune responses in those who received the vaccination following BCG vaccination, the consortium said.
“No matter how promising the candidate would be as a potential TB vaccine, we wouldn’t support it until we were sure that enough of it could be made.”
“I am excited by the further development of this promising vaccine candidate,” McShane said in a statement. “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.”
Based in Rockville, Md., and with offices in the UK, Germany, and Singapore, Emergent manufactures and commercializes vaccines and therapeutics designed for what it says are mostly underserved medical markets.
Its sole marketed product, the anthrax vaccine BioThrax, is the only vaccine approved by the US Food and Drug Administration to prevent anthrax infection.
Aeras’ Sadoff also said that Emergent’s manufacturing experience was a key factor in the foundation’s decision to work with the company.
“One of our concerns about the Oxford product all along has been that it is generally produced in eggs, which is fine,” Sadoff said. “But for our mission, we need to make sure that any vaccine we help develop is available at a very reasonable cost to the developing world – generally less than $1 or $2 per dose – and we need about 100 million doses per year.”
If the vaccine proved effective in adults and adolescents, for which there is evidence, then another 100 million doses would likely be needed. “Our feeling was, from our due diligence, that [these additional 100 million doses] couldn’t be done in eggs very easily, if at all.”
He said that several companies and independent researchers have been trying to overcome the limitations posed by eggs by developing techniques using continuous cell lines – usually duck embryos – to grow the virus on a much larger scale; and that the Oxford-Emergent consortium has expressed interest in adopting some of those methods for the MVA85A vaccine.
“That’s what allowed us to go forward,” Sadoff said. “No matter how promising the candidate would be as a potential TB vaccine, we wouldn’t support it until we were sure that enough of it could be made, because our mission is to make something for the developing world.”