Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on 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 two candidates in multiple Phase II trials, and a preclinical targeted antibody therapy in collaboration with Wyeth. A Phase III trial in renal cancer with TroVax, the lead cancer immunotherapy candidate, is expected to start in the second half of 2006. In neurotherapy, the Company's lead product is a gene therapy for Parkinson's disease, which is expected to enter clinical development 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, Virxsys and Kiadis; and has licensed technology to a number of companies including Merck & Co, Biogen Idec and Pfizer.

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. TroVax has attracted external support from Cancer Research UK, the US National Cancer Institute and the UK clinical trials network, QUASAR. Over 150 patients have now been treated with TroVax in ten clinical trials (collectively over 500 doses). The Company is targeting colorectal cancer and renal cell carcinoma as lead indications for the development of TroVax. Renal cell carcinoma is an indication where TroVax might achieve a rapid route to product registration. Oxford BioMedica is starting a Phase III trial (TRIST – TroVax Renal Immunotherapy Survival Trial) in 700 patients with advanced renal cell carcinoma in the second half of 2006. The TRIST study received a Special Protocol Assessment from the US Food and Drug Administration in May 2006. A Phase II trial in prostate cancer is ongoing and a trial in breast cancer is due to start under the auspices of the US Southwest Oncology Group.

Renal cell carcinoma (RCC) is the most common form of kidney cancer in the USA. More than 150,000 people are newly diagnosed with RCC worldwide each year. Prognosis is very poor. If RCC has metastasised to other organs at the time of first diagnosis, the five-year survival rate is less than 5%. In the USA and Europe, RCC accounts for more than 33,000 deaths each year. Data from IMS suggest that over 5,000 patients in the UK received treatment for metastatic RCC in 2005.

The most common form of RCC is known as clear cell, which is evident in approximately 80% of cases. The other main category is papillary, which is found in 15-20% of cases. Commonly used treatments for patients with metastatic RCC include cytokines such as interferon-alpha, which has limited efficacy, and interleukin-2, which is associated with severe side effects at high dose levels. In the last 12 months, two novel kinase inhibitor drugs have been approved for the treatment of metastatic RCC, Nexavar® and Sutent®, based on progression free survival and overall response rate data, respectively, rather than improvement in survival.

There are several reasons why a cancer vaccine such as TroVax might have therapeutic potential as a novel treatment for RCC. There is circumstantial evidence that immune responses may be important in dictating the outcome for RCC patients and a vaccine could potentiate this immune response. TroVax, in particular, may be the vaccine of choice since the expression of 5T4, the antigenic component of TroVax, is more prevalent in RCC than any other solid cancer analysed by Oxford BioMedica: the antigen is present at high levels on a high proportion of cells in approximately 90% of RCC tumours.

Treatments for RCC generated annual sales of approximately US$600 million according to Datamonitor.