Eden Biodesign Ltd has announced that it has signed agreements with Cancer Research UK (CR-UK) to provide consultancy, process development and manufacturing services for two of CR-UK’s gene therapy products: AdhTR- 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. Activation of the hTR promoter in cancer cells drives bacterial nitroreductase expression and converts the inactive prodrug CB1954 into its active form leading to cell death.
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 agreements, 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.
Eden Biodesign will also develop the manufacturing process and associated analytical testing for these therapies. Depending on achieving preclinical development milestones, Eden Biodesign will provide cGMP (current Good Manufacturing Practices) production of Ad-hTR-NTR and Ad.CPG2 for the Phase I clinical trials. The complete project could take up to 18 months and reach £1.5 million in value.
The development work will take place primarily at the UK National Biomanufacturing Centre which is run by Eden Biodesign.