DNA vaccine supply agreement with South African AIDS vaccine initiative ’could lead to commercial supplies’
Cobra Biomanufacturing, international manufacturer of biopharmaceuticals, will supply clinical trial and, potentially, commercial supplies of DNA vaccine to the South African AIDS Vaccine Initiative (SAAVI), one of the South African Medical Research Council’s lead programmes.
SAAVI and its partners at the University of Cape Town are developing a DNA vaccine approach for immunisation against AIDS caused by the HIV-1 Clade C virus. Clade C is the most prevalent type of HIV in the African and Asian continents, accounting for over 90% of new infections in the southern African region. With travel and immigration on the increase, Clade C is also likely to continue to spread globally.
In the most significant agreement to date, Cobra will supply SAAVI with DNA for Phase I/II clinical trials. For Phase III and commercial sale of the vaccine, Cobra will have the right of first refusal to supply commercial (bulk) DNA.
SAAVI will hold all rights to any bulk vaccine distributed within southern Africa while Cobra will hold rights to exploit the vaccine internationally (excluding southern Africa). The agreement includes the possibility of a technology transfer to a South African partner, to ensure as broad a coverage as possible of a successful HIV vaccine.
The global market for AIDS vaccines is significant. 40 million individuals are already infected with HIV worldwide, nearly 30 million of whom live in sub-Saharan Africa.
Mass production of DNA vaccine is produced in bacteria as plasmid DNA. Plasmid DNA is conventionally produced by a process using antibiotics and the plasmid DNA itself contains a gene for antibiotic resistance. In conventional treatments, using products from other manufacturers, the patient is injected with a vaccine containing genes for antibiotic resistance. Cobra has developed a unique, patented manufacturing system, ORT, which neither uses antibiotics nor antibiotic resistance genes. Cobra's ORT platform was important for Cobra's winning this contract and it places the Company in a good position to win other, similarly large, high-profile contracts.
David Thatcher, Chief Executive of Cobra Biomanufacturing, delighted by Cobra's success, sees the joint programme "will provide a greater opportunity for the development of new and successful products."
"The value to Cobra of having access to a vaccine of such huge potential globally should not be underestimated. We are very excited about this agreement, with Phase I trials due to commence in 2004."
Tim Tucker, Director of the SAAVI, comments: "Cobra is well known for its innovative manufacturing process. It is our hope that we will find this candidate HIV vaccine effective in inducing a vigorous immune response and eventually having a possible impact on the HIV pandemic."
Keywords : Cobra Biomanufacturing HIV AIDS Vaccine South Africa Phase I & II clinical trials
