Professor Richard Kennedy of Queens University College Hospital in Belfast has led the development of pioneering tests that analyse tumour DNA to identify patients with colon cancer who are likely to develop the disease again after surgery, and also patients with breast cancer who would benefit from chemotherapy after surgery. Professor Kennedy heads up the Belfast Experimental Cancer Medicine Centre (ECMC) and tells us about his work as part of a UK-wide network of 18 ECMCs, which provide dedicated funding to support early phase clinical cancer trials.
At Queen’s University we have recognised that much basic research performed in the academic setting fails to impact cancer patient care. One of the major issues we identified was that there was a disconnect between the type and quality of research being performed in the academic community and the ability of industrial partners to commercialise the results and introduce products into the clinic. We therefore have established a pipeline from basic research to the patient which involves collaboration with industrial partners and the ECMC Network from the initial research to the validation of a final product in clinical trials. This begins with basic science in the university laboratory supported by data, reagents and expertise from industrial partners. Importantly we get regulatory and commercial guidance early on in the process to ensure that there will be industrial interest for successful research, which is essential to make an impact on clinical practice.
Within this pipeline the university typically takes research to a “proof of principle stage” ready for product development in collaboration with an industrial partner.
The industrial partner defines what the specifications would be for a successful pilot product that could enter development. In our experience, product development is particularly expensive and is usually outside the scope of academic institutes, so it is important to ensure an industrial partner is satisfied with the pilot data. In the case of biomarker development, the industrial partner will usually invest in the analytical work and the clinical validation in human samples that is required by regulatory authorities prior to use in the clinic. For drug targets, the industrial partner will usually take a hit compound and develop it into a lead compound which is suitable for prospective clinical trials. As part of this pipeline, we then offer to perform a clinical trial of the developed product within the ECMC network. A key strength in this approach is that clinical samples are collected by the Northern Ireland Biobank (NIB) as part of the clinical studies and are then analysed by the basic scientists who performed the original research to help refine the therapy or develop new approaches that will lead to further products.
Importantly we can collaborate with industrial partners anywhere along the pipeline. For instance, some companies may only want to partner on the basic research to pilot product phase whereas others may be more interested in the clinical trial and sample collection part of the pipeline. Examples of products that have gone through this pipeline are as follows:
- Queen’s University identified a novel anti-angiogenic target that could be inhibited using a protein. Almac (UK), a local pharmaceutical company, developed a peptide (ALM201) that could be commercially manufactured and then performed the necessary regulatory steps to allow human studies. The Queen’s University Belfast /Northern Ireland Clinical Trial Centre will open a clinical trial of ALM201 in ovarian cancer in June 2014. This is accompanied by a biomarker also identified by Queen’s University. This trial is being run within the ECMC network and will initially involve three centres before expanding out through the rest of the network.
- Queen’s University and Almac Diagnostics identified a new biomarker for chemotherapy sensitivity in breast cancer. Almac developed the assay so it fulfilled regulatory requirements around analytical performance. Both collaborators identified a large retrospective cohort of patients to validate the biomarker and it was then out-licensed to Genomic Health (USA) for $9 million with royalties. An ECMC sponsored prospective clinical trial evaluating the biomarker in the neoadjuvant chemotherapy setting in breast cancer commenced in April 2014.
The ECMC Network is a UK-wide initiative jointly funded by Cancer Research UK and the four UK health departments to bring new therapies to patients by dedicating funding for clinical cancer research. For more information on the ECMC Network and how it supports the work of experimental cancer research, visit http://www.ecmcnetwork.org.uk/ or contact the team at firstname.lastname@example.org or 020 34695381. You can follow the ECMC Network on Twitter at @ECMC_UK and the team has just started a LinkedIn group at ECMC Company Page.