PRODUCT DESCRIPTION
MetXia is a gene-based therapeutic for localised treatment of cancer that is used to enhance the efficacy of cyclophosphamide (CPA). The product is based on a highly engineered retrovirus vector expressing the human cytochrome P450 gene, CYP2B6. MetXia converts a tumour into a ‘drug factory’, enabling increased local production of the anti-tumour, cytotoxic derivative of the prodrug of CPA. MetXia is potentially useful in the treatment of all solid tumours and their metastases, particularly in those indications where CPA has proved to be effective.

INDICATION
All solid tumours where CPA may be used as chemotherapy. This includes pancreatic, breast, head and neck, ovarian and liver cancers.

MARKET
Oxford BioMedica is focusing on pancreatic cancer as an initial indication for the development and commercialisation of MetXia. Annual sales of existing therapies for pancreatic cancer are approximately US$600 million (Datamonitor).

TECHNICAL DESIGN
A third generation retroviral vector delivering the CYP2B6 gene. The CYP2B6 gene encodes a P450 enzyme, which activates CPA to the cytotoxic form of the drug.

CLINICAL STATUS
Completed Phase I/II Trial
Breast Cancer and Melanoma (two trials)

• Advanced breast cancer with accessible tumours and some cases of melanoma
• MetXia administered directly to the tumour and CPA administered orally
• Two formulations of MetXia were shown to be safe and well tolerated
• The P450 gene, delivered by MetXia, was readily detected in the treated tumours
• Clinical benefits were seen in some patients, including tumour size reduction

Ongoing Phase II Trail
Pancreatic cancer

• Non-resectable pancreatic cancer
• MetXia and CPA delivered directly to the tumour for localised activation of CPA
• A two-stage trial, firstly to evaluate the optimal dose of MetXia and secondly, the optimal dose of CPA
• Two dose levels of MetXia were evaluated in the first stage of the trial and both were safe and well tolerated
• Dose-dependent expression of the P450 gene, delivered by MetXia, was observed in tumour biopsies taken at surgery
• Patient recruitment is ongoing for the second stage of the trial
• Three dose levels of CPA have been successfully evaluated to date

COMMERCIALISATION STRATEGY
Commercial partners sought to co-develop and market the product.

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