Oxford, UK: 22 November 2005 – Oxford BioMedica (LSE: OXB), a gene therapy company, announced today that the US Patent and Trademark Office has issued a Notice of Allowance for a key patent application (USSN 09/533,798), which significantly extends the protection of TroVax, the Company’s lead cancer vaccine. It is expected that the patent will be issued during 2006. This patent is one of several granted and pending patents that protect the Company’s use of the 5T4 tumour antigen. The Notice of Allowance covers immunotherapy approaches directed against the 5T4 tumour antigen.

5T4 is a tumour associated antigen that is expressed at high levels on a wide range of tumour types, including colorectal cancer, renal cell carcinoma and breast cancer, amongst others. 5T4 expression is frequently correlated with poor prognosis and metastatic spread.  Although present on tumour cells, 5T4 is not found on any essential organs. These and other unique characteristics make 5T4 an ideal target for immunotherapy treatment in a wide range of cancer types.

Commenting on the Notice of Allowance news, Peter Nolan, Oxford BioMedica’s Senior Vice President for Commercial Development said: “We are delighted to have been allowed such broad claims for this key US patent. This Notice of Allowance, together with several other granted and pending patents, provide clear protection in most major territories for our lead product, TroVax, as well as next generation cancer vaccines based on the 5T4 antigen. Today’s news further strengthens our negotiating position with potential partners for TroVax as we progress into Phase III development.”
 

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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 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 70 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, Sigma-Aldrich, Viragen, MolMed and Kiadis; and has licensed technology to a number of companies including Merck & Co, Biogen Idec and Pfizer.

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.

TroVax is currently in five Phase II trials, including an investigator initiated trial sponsored by Cancer Research UK. Over 85 patients have been treated with TroVax (collectively over 350 doses) in five clinical trials in colorectal cancer and renal cell carcinoma. Clinical results have shown that the product is safe and stimulates an anti-tumour immune response against 5T4 in the majority of patients. Data from the completed Phase I/II trial and ongoing Phase II trials suggest that the magnitude of the immune response induced by TroVax correlates with clinical benefit including tumour responses and time to disease progression, both of which have exceeded expectation based on published historical data. A Phase III trial in renal cell carcinoma is planned to start in 2006.