CLIMATE CHALLENGE - Isis Innovation

Oxford signs deal to developworld’s leading TB vaccineOxford-Emergent Tuberculosis ConsortiumTuberculosis (TB) is the world’s second leadingcause of death from infectious disease in adults,after HIV/AIDS, with over one third of the world’spopulation infected and an estimated 1.7 milliondeaths directly attributable to the disease everyyear. Drug-resistant forms of TB are also on therise, raising concerns about the increasing threatfrom TB and leaving many patients withouteffective treatment.A new TB vaccine, developed at the University of Oxfordby Dr Helen McShane in concert with Dr Sarah Gilbert andProfessor Adrian Hill, has the potential to address this globalproblem. The MVA85A tuberculosis vaccine candidate isdesigned to enhance protective immune responses inindividuals who have already received the BCG vaccination,and has successfully completed several Phase I and II clinicaltrials in the UK and Africa. To date, the Oxford vaccinecandidate is the most clinically advanced new TB vaccine indevelopment.In a move to facilitate the continued development of thevaccine, the University, together with the U.S. vaccinedeveloper Emergent BioSolutions Inc has formed a jointventure, the Oxford-Emergent Tuberculosis ConsortiumLtd (OETC). Isis, which has been responsible for protectingthe intellectual property surrounding the vaccine to date,managed the formation of OETC on behalf of the University,and has exclusively licensed to the joint venture the MVA85Atuberculosis vaccine candidate and related technology.In addition, two prominent non-governmental organizations,the Wellcome Trust and the Aeras Global TB VaccineFoundation (Aeras), have each committed £4 million towardsfunding a soon-to-be-initiated Phase IIb study in infants.The Phase IIb trial will take place at the Worcester sitein South Africa, which was developed by the Universityof Cape Town and Aeras and is the next critical stepin MVA85A’s development. With this large scale trial,researchers hope, for the first time, to demonstrate thatthe vaccine candidate not only induces powerful immuneresponses, but also that these responses protect individualsfrom the disease.If successful, this could lead to a full scale Phase III clinicaltrial, which is required for licensure of the vaccine in theinfant indication. It is also hoped that successful resultsin infants will pave the way for the vaccine to be used tovaccinate adolescents and individuals infected with HIV/AIDS. The latter indication is of great importance as TB is themost frequent cause of death in those with AIDS.Should MVA85A successfully complete clinical developmentand reach the market, Emergent BioSolutions Inc willhave the right to sell the vaccine in the Developed Worldcommercial markets, with Aeras having the right to providethe vaccine at an affordable price in the Developing World.The formation of OETC represents a novel approach tofacilitating the development of a vaccine aimed primarily (interms of number of doses) at low margin Developing Worldmarkets, and demonstrates that a public-private partnershipcan be an effective vehicle for managing the interests ofthe complex array of stakeholders associated with such aproject.contactDr Adam StotenProject Team Manager, Technology Transfer GroupT 01865 280909E adam.stoten@isis.ox.ac.ukW www.isis-innovation.com8