Oxford, UK: 9 May 2005 – Oxford BioMedica (LSE: OXB), the leading gene therapy company, today announced that the European Patent Office has granted a key patent (No. EP1036091), that provides broad protection for Oxford BioMedica’s lead product, TroVax. This is one of several granted and pending patents that protect the Company’s ownership of the 5T4 tumour antigen. The granted patent covers immunotherapy products directed against 5T4 and includes specific claims to the use of viral delivery systems in 5T4-targeted vaccines.

5T4 is a tumour associated antigen that is expressed on a wide range of tumour types. A number of published immunohistochemical studies have demonstrated that there is a high incidence of 5T4 expression on colorectal cancer, renal cell carcinoma and breast cancer, amongst others. 5T4 expression is frequently correlated with poor prognosis and metastatic spread.  Overall, 5T4 is present on more than 75% of human solid tumours, yet it is not found on any essential organs. These characteristics make 5T4 an ideal target for immunotherapy treatment in a wide range of cancer types.

Commenting on the issued patent Oxford BioMedica’s Chief Executive, Professor Alan Kingsman said: “The newly granted patent, together with several other granted and pending patents, provide protection for our lead product, TroVax, as well as next generation cancer vaccines based on the 5T4 antigen. This positions Oxford BioMedica as one of the leading players in the emerging field of cancer immunotherapy. TroVax has potential utility as a treatment for most solids tumours, hence, the potential to be a major commercial opportunity for the Company.”

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Notes to editors:

1. Oxford BioMedica

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on the areas of oncology and neurotherapy. The Company was established in 1995 as a spin out from Oxford University, and is listed on the London Stock Exchange.  

Oxford BioMedica has core expertise in gene delivery, as well as in-house clinical, regulatory and manufacturing know-how. In oncology, the pipeline includes an immunotherapy and a gene therapy in multiple Phase II trials, and a preclinical targeted antibody therapy in collaboration with Wyeth. In neurotherapy, the Company’s lead product is a gene therapy for Parkinson’s disease, which is expected to enter clinical trials in early 2006, and four further preclinical candidates. The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. 

The Company has a staff of approximately 65 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Amersham, Viragen, MolMed and Kiadis; and has licensed technology to a number of companies including Merck & Co and Biogen Idec. 

Further information is available at www.oxfordbiomedica.co.uk.

2. TroVax^® cancer immunotherapy

TroVax is Oxford BioMedica’s leading cancer immunotherapy product. It is designed specifically to stimulate an anti-cancer immune response and has potential application in most solid tumour types. TroVax targets the tumour antigen 5T4, which is broadly distributed throughout a wide range of solid tumours. The presence of 5T4 is correlated with poor prognosis. The product consists of a poxvirus (MVA) gene transfer system, which delivers the gene for 5T4 and stimulates a patient’s body to produce an anti-5T4 immune response. This immune response destroys tumour cells carrying the 5T4 protein.

Two Phase I/II trials with TroVax have been completed in the UK in late stage colorectal cancer patients. The results showed that the product is safe; that patients mount an anti-5T4 immune response; and that the immune response correlates, with high significance, to time to disease progression, which translates into a correlation with improved overall survival.

Four Phase II trials are underway. Positive initial data from trials investigating TroVax in colorectal cancer in combination with first line standard of care treatment and as a (neo) adjuvant to surgery were released on 2 March 2005. A further Phase II trial is ongoing in renal cell carcinoma, and the US National Cancer Institute, through the Southwest Oncology Group, is planning an additional Phase II trial in breast cancer.