Liverpool, UK-based Eden Biodesign, a provider of development and manufacturing services for new biopharmaceutical medicines, says that it has signed agreements with Cancer Research UK, a charity dedicated to cancer research, to provide consultancy, process development and manufacturing services for two of the latter's gene therapy products: Ad-hTR-NTR for advanced intra-abdominal cancer and Ad.CP62 for head and neck cancer.
Ad-hTR-NTR is a telomerase-targeted adenoviral suicide gene therapy vector, which is active in telomerase expressing cancer cells. Ad.CPG2 is a conditionally replication-competent oncolytic adenovirus that expresses carboxypeptidase G2 (Ad.CPG2). Activation of the prodrug (ZD2767P) by CPG2 releases a potent alkylating mustard preventing tumour proliferation by DNA cross-linking.
Under the terms of the deal, Eden Biodesign will provide strategic advice to produce an effective development plan that will optimize the preclinical process with a view to expediting clinical manufacture and supply. It will also develop the manufacturing process and associated analytical testing for these novel therapies. Depending on achieving preclinical development milestones, Eden Biodesign will provide current Good Manufacturing Practices production of Ad-hTR-NTR and Ad.CPG2 for the Phase I clinical trials. The project could take up to 18 months to complete and reach L1.5 million ($3.0 million) in value.
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