Oxford Biomedica Regulatory News (OXB)

Oxford BioMedica Announces Initiation of Phase II Collaborative Study for TroVax® in Mesothelioma

-- First patient treated at Velindre Cancer Centre, Wales (UK) --

Oxford, UK - 7 March 2013: Oxford BioMedica plc ("Oxford BioMedica" or "the Company") (LSE: OXB), the leading gene-based biopharmaceutical company, today announces that its partners at the Velindre Cancer Centre, one of the largest cancer centres in the UK, have initiated a Phase II trial to assess the safety and immunological activity of TroVax®, a therapeutic vaccine developed by Oxford BioMedica, in combination with first-line chemotherapy agents pemetrexed and cisplatin in patients with malignant pleural mesothelioma. The study will be funded by the June Hancock Mesothelioma Research Fund (JHMRF) and the Velindre Cancer Centre Stepping Stones Appeal, and Oxford BioMedica will provide TroVax®.

The Phase II study, entitled "SKOPOS", will be led by Dr Jason Lester at Velindre Cancer Centre in Cardiff, Wales, with Dr Zsuzsanna Tabi as Co-Investigator, and will enrol 26 patients with malignant pleural mesothelioma (MPM). The study will evaluate whether TroVax® is active in the treatment of MPM, assessed by measuring anti-5T4 immune responses following treatment in combination with pemetrexed and cisplatin. The study will also assess secondary measures of clinical benefit including progression-free survival, objective response rate and overall survival at six and 12 months.

TroVax® is a therapeutic vaccine that stimulates the immune system to destroy cancerous cells expressing the 5T4 tumour antigen which is present on most solid tumours. Dr Zsuzsanna Tabi at Cardiff University and a team of cancer immunologists previously undertook a feasibility project, also funded by the JHMRF, where the 5T4 tumour antigen was shown to be present on mesothelioma cells. Mesothelioma is a relatively rare form of cancer which affects the tissue lining of the lungs (the pleura) and, less commonly, the lining of the abdomen (the peritoneum). The disease can take 10-50 years or longer to develop and is usually associated with asbestos exposure. It is estimated that every five hours someone dies from mesothelioma in the UK and the annual number of deaths is expected to remain above 1,500 until 2025 (source: JHMRF).

Commenting on the collaboration, John Dawson, Chief Executive Officer of Oxford BioMedica, said: "This study is the first to evaluate TroVax® as a treatment for mesothelioma in the UK and we are privileged to be working with the immunology team at Velindre Cancer Centre. TroVax® has been shown to be effective at inducing immune responses in multiple types of cancer and, with few treatment options available for mesothelioma, could hold significant promise against this increasingly prevalent form of cancer."

Dr Jason Lester, Chief Investigator at Velindre Cancer Centre, commented: "I am delighted that the SKOPOS study is now open. Mesothelioma is one of the hardest cancers to treat and can be very debilitating for patients. We are hopeful that TroVax® in combination with chemotherapy will show promise and lead to better outcomes for patients with mesothelioma."

Dr Kate Hill, trustee of the June Hancock Mesothelioma Research Fund, said: "Given the limited options available for the treatment of mesothelioma, the Fund is thrilled to support the SKOPOS study. We are also delighted to continue our association with the Velindre Cancer Centre and enable the valuable laboratory work previously funded by the June Hancock Mesothelioma Research Fund to move on to the next stage. There is no doubt that new approaches to treating mesothelioma are needed; this study is an important step forward."

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Notes to editors

1. Oxford BioMedica®

Oxford BioMedica plc (LSE: OXB) is a biopharmaceutical company developing innovative gene-based medicines and therapeutic vaccines that aim to improve the lives of patients with high unmet medical needs. The Company's technology platform includes a highly efficient LentiVector® gene delivery system, which has specific advantages for targeting diseases of the central nervous system and the eye; and a unique tumour antigen (5T4), which is an ideal target for anti-cancer therapy. Through in-house and collaborative research, Oxford BioMedica has a broad pipeline with current partners and licensees including Sanofi, Pfizer, GlaxoSmithKline, MolMed, Sigma-Aldrich, Biogen Idec, Emergent BioSolutions, ImaginAb and Immune Design Corp. Further information is available at www.oxfordbiomedica.co.uk and www.oxbsolutions.co.uk.

2. TroVax®

TroVax® is a therapeutic vaccine that stimulates the immune system to destroy cancerous cells expressing the 5T4 tumour antigen which is present on most solid tumours. The product comprises a modified vaccinia virus Ankara (MVA) vector, encoding the 5T4 antigen. Vaccinia viruses are commonly used as delivery systems for the development of antigen-specific vaccines. Results from 10 previous clinical trials in colorectal, renal and prostate cancer have shown that TroVax® is safe and well tolerated in over 500 patients; can be administered in combination with various other treatments and show clear indication of efficacy. Approximately 90% of patients treated with TroVax® mounted an anti-cancer immune response to the 5T4 antigen.

3. The June Hancock Mesothelioma Research Fund

The June Hancock Mesothelioma Research Fund is an independent UK mesothelioma charity (Registered No 1121784). The Fund supports high quality research in mesothelioma, raises awareness of the disease amongst healthcare professionals and the public at large and provides information for mesothelioma sufferers and their carers. Further information is available at www.junehancockfund.org.

4. Velindre Cancer Centre and Velindre Cancer Centre Stepping Stones Appeal

Velindre Cancer Centre provides specialist cancer services to over 1.5 million people in South East Wales and beyond. It is one of the largest cancer centres in the UK. Each year over 5,000 new referrals and around 50,000 new outpatient appointments are seen. The centre employs over 670 staff with an annual budget of £49 million. Velindre Cancer Centre Lung Cancer Research Department has launched the Stepping Stones Appeal to increase awareness of its work, and to raise the money necessary to continue to fund and expand its research programmes. Further information is available at www.velindrefundraising.com.