Eden's bio garden grows

The two projects will mainly be carried out at the UK's National Biomanufacturing Centre (NBC) - which is run by Eden - and could take up to 18 months and reap in £1.5m (€2.2m) for the Liverpool-based biopharmaceutical development and manufacturing services provider. Eden has been enlisted to provide consultancy, process development and manufacturing services for two of the cancer charity's leading gene therapy products: Ad-hTR-NTR for advanced intra-abdominal cancer and Ad.CP62 for head and neck cancer. Specifically, the firm said it will advise Cancer Research UK on producing a development plan that will optimise the preclinical process and expediting clinical manufacture and supply of the two drug candidates. Eden will also develop the manufacturing and analytical testing processes for the compounds, which are among a number of new generation biopharmaceuticals popping up in pharma pipelines, designed to specifically target antigens unique to cancer cells and destroy these cells without harming healthy tissue, and thus offer a new cutting-edge approach to tackle this deadly disease area. They are produced through a method called bioprocessing, which involves taking living cells and turning them into manufacturing units. 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. If the collaboration between the two organisations goes well, Eden Biodesign will be retained by the charity to provide current Good Manufacturing Practices (GMP) production of the drugs for Phase I clinical trials. The firm's facility in Speke, Liverpool was cleared in May by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to produce investigational medicinal products for clinical trials. Between 2001 and 2006, Eden Biodesign provided biopharmaceutical development services to more than 70 clients in Europe, US, Asia and Australasia, ranging from large pharmaceutical companies to major charity organisations. In 2006 Eden won the contract to operate the new NBC - a £34.25m government-funded initiative to help biotechnology start-ups get their product ideas into clinical trials and also establish England's Northwest as one of the top biomanufacturing hubs in Europe. The UK is now second only to the US in terms of its biopharmaceuticals development pipeline, however, the country's industry still lags a long way behind the US and the UK government has been making a concerted effort to close this gap. Since the NBC's inception Eden has been busy inking new deals with a plethora of budding biotechs - at the beginning of August the firm inked two such deals in as many weeks. The first was with the University of Birmingham under which the company will develop and produce a novel therapeutic candidate for the treatment of autoimmune diseases such as multiple sclerosis and rheumatoid arthritis. Shortly after this Eden inked another deal with the University of Manchester Intellecutal Property (UMIP) - the university's managing agent IP commercialisation. The firm was selected by UMIP to provide a range of services for the development of a drug aimed at treating macular degeneration and cancer. Following its new GMP status, Eden announced in March that it had been chosen by UK biotech firm ImmBio to provide development and manufacturing services for its leading influenza vaccine programme. The aim of the deal was to optimise the manufacturing process of both seasonal and pandemic flu vaccines, where manufacturing speed and flexibility are critical, to meet unmet market needs. Meanwhile, Eden has also started to supply GMP clinical manufacturing services to UK biotech Onyvax for the latter's cell vaccine programme against ovarian cancer. The Onyvax-O vaccine, which is being developed by Onyvax under a collaborative licence agreement with the US Mayo Clinic, is currently in preclinical trials. The ovarian carcinoma cell lines were developed by the Mayo Clinic for use as human therapeutics. The Onyvax contract was the first at the NBC to benefit from a £2.7m Access Fund, supported by the UK Department of Trade and Industry and the European Regional Development Fund, which helps qualifying small-to medium-sized companies and academic groups to purchase development and clinical manufacturing services from the centre. In addition, Eden was asked to extend a project with Silence Therapeutics (formerly SR Pharma) that involves delivering to the UK biotech a whole-cell microbial immunotherapeutic for the treatment of asthma, cancer and tuberculosis.