Cobra Biomanufacturing of the UK has signed an agreement to supply the USA's Advaxis with clinical and commercial supplies of the active ingredient for its Listeria monocytogenes-based cancer vaccine.
This is Advaxis' leading product and it is due to start clinical trials as a cervical cancer treatment within the next 12 months, following encouraging preclinical studies which suggest that a weakened version of L monocytogenes can induce the body's immune system to mount an anticancer response.
J Todd Derbin, Advaxis' chief executive, said: "It is very important to Advaxis to be working with a CMO that manufactures to US and European regulatory standards, and offers us multiple options in the planning of future clinical trials in a range of indications."
Cobra, a specialist in the manufacture of DNA, viruses and proteins, is already using its expertise for the production of L monocytogenes for the preclinical studies being undertaken by Advaxis. This production will increase significantly as the cancer vaccine moves into the clinic - with Phase I trials anticipated to last 12 months.
There is currently believed to be a shortfall in production capacity in the biopharmaceutical sector, resulting from a lack of investment in this area during the 1990s. This in turn resulted from an overcapacity at the beginning of the decade, when first-generation monoclonal antibody-based therapeutics failed to live up to their early promise and left companies with 'white elephant' manufacturing plants.