Oxford BioMedica hopes vaccine first will raise interest
pharmafile | May 5, 2010 | News story | Sales and Marketing | Dendreon, Oxford BioMedica, Provenge, TroVax
Oxford BioMedica is hoping that the approval of the world’s first immunotherapy cancer vaccine in the US will help it find a big pharma partner for its product.
The UK company’s lead product is the cancer vaccine TroVax, but its chances were dealt a blow in April 2009, when Sanofi-Aventis pulled out of a development deal after it failed to prove its worth in phase III trials.
Now rival US biotech firm Dendreon has gained FDA approval for its prostate cancer vaccine Provenge – a breakthrough which Oxford Bio-Medica hopes will inspire confidence in its product.
Analysts have forecast peak sales of Provenge as high as $1billion a year, but because the approach is so novel, just how successful it will be remains unclear.
John Dawson, chief executive of BioMedica, said the Provenge approval was a “landmark in the field of therapeutic cancer vaccines”. As Dendreon is the first company to say it is ‘okay to get into the water’, Dawson is hopeful this will pave the way for more cancer vaccines and greater funding for development projects.
Cancer vaccines are at the cutting edge of science, and a number of other rival products have suffered setbacks in recent months.
TroVax failed to meet its primary efficacy endpoint in phase III trials in 2009, with the Data Safety Monitoring Board stating that overall survival improvement would not be increased. It was originally indicated for colorectal, prostate and renal cancers.
Chairman Professor Alan Kingsman told Pharmafocus that in the phase III TRIST study, half of the 733 patients treated with the vaccine would have met this endpoint and that “even though this was deemed an official failure, we see it as an encouraging success for our future trials”.
Following Sanofi’s exit, the company has scaled back development and will start new phase II trials for the vaccine this year. It is developing the vaccine using low cost trials and funds remaining from its collaboration with Sanofi. Initially, the indications will be for colorectal and prostate cancers with a renal cancer indication a potential for an additional, future regulatory approval.
Stimulating the body’s immune system Provenge has been developed by Dendreon to treat prostate cancer and works by cells being removed from patients, modifying them and then re-introducing them to activate an immune response.
BioMedica’s TroVax uses a series of injections over several months, mimicking traditional immunisation techniques, to stimulate an immune response to destroy cancerous cells expressing the 5T4 tumour antigen.
The injections consist of a modified virus that carries apart of the tumour to the cancerous site. The patient’s immune system recognises the antigen and reacts against this by sending antibodies and killer T-cells to the tumour, thereby preventing further growth and potentially reducing tumour size.
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