Smallpox virus: a disabled form of it is used as a vector for drug delivery. Photo courtesy Smallpox BioSecurity
This is the first time a top-tier pharmaceutical company has offered such public endorsement of this type of product: TroVax uses vaccinia, a disabled form of smallpox virus, to deliver the gene for an antigen called 5T4 that occurs on the surface of solid tumours. This stimulates the body to produce an anti-5T4 immune response, which destroys cancer cells carrying 5T4.
The gene therapy race
TroVax is not the most advanced gene therapy product in development.
Ark Therapeutics plc’s Cerepro for treating glioma became the first
gene therapy product to move into a full regulatory review (outside
China) in 2005 when the European regulator EMEA accepted it for the
"exceptional approval" route on the basis of two previous Phase II
trials.
The product uses an adenovirus to deliver the gene for the enzyme
thymidine kinase, which converts a prodrug into a form that is toxic to
tumour cells, but has no effect on normal brain cells. The London-based
company has a further gene therapy product, Trinam in Phase III
development also.
However, TroVax is the first gene therapy to attract a big-ticket
pharma deal. Kingsman said the commercial success of TroVax would
depend on how it now performs in Phase III trials. “The theoretical
[commercial] potential is huge, but it depends on how the efficacy
reads out.”
This deal has been 18 months in the making. Alan Kingsman, CEO of Oxford BioMedica, said it fulfilled all the requirements on the wish list that he compiled when embarking on partnership discussions. “Sanofi-Aventis is absolutely an ideal partner for TroVax,” he said.
This is not only based on the Sanofi-Aventis’s global reach and resources, and its strong position in the cancer market in general, but also because the Paris-based company is devoting internal R&D resources to cancer immunotherapy.
Kingsman said the size of the deal reflected the fact that other potential partners were in competition to take on the product. He believes this licence could unlock the commercial potential of cancer immunotherapy in general.
The €518 million headline figure depends on meeting all development and registration targets in certain defined tumour types, with additional payments for further other types of cancer. In addition, Oxford BioMedica will receive royalties and commercial milestones when sales of TroVax reach certain levels.
The Oxford-based company has retained the right to participate in the development of TroVax for cancers other than those specified at this point, in return for an enhanced royalty. In the immediate future it will be responsible for manufacturing and supplying TroVax to Sanofi on commercial terms, and so will have a revenue stream from this activity also.
On signing the agreement Sanofi paid €29 million upfront, and will make further near-term payments of €19 million, linked to clinical milestones in the ongoing Phase III trial in renal cancer, which is due to complete within two years.
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