The biomarker technology was invented by EpiStem, a biopharmaceutical company based in the UK, which specialises in epithelial stem cells. Its science team has discovered a method that uses hair to measure gene expression and has now entered into 'feasibility studies' with AstraZeneca. Financial deatils of the deal were not disclosed. This provides drug developers with information on drug exposure, toxicity, dose/schedule and patient selection in both preclinical and clinical tests. "We are very excited about our biomarker developments and believe that our technology will accelerate the development of new cancer therapeutics throughout development and is well placed to improve the effectiveness of existing treatment regimens," said Dr Jeff Moore, head of novel therapies at EpiStem. Developing a single drug is estimated to cost up to $1.2bn (€890m), although a significant proportion of this cost comes after factoring in expensive failures. EpiStem's technology could help preclinical assessment of drugs, inform 'go/no-go' decisions and thereby reduce the risk in drug development.
Biomarker analysis is nothing new in the world of drug discovery. However, scientists typically use blood samples to conduct the experiments. This new technique from EpiStem is much less invasive - undoubtedly good news for cancer patients who already suffer greatly, both from the disease and the unpleasant side-effects of medication. For over three decades, EpiStem's co-founder, Professor Chris Potten has been conducting groundbreaking research on stem cells. He identified and characterised the location and behaviour of stem cells in the small intestine, skin and hair. The link between stem cells in the small intestine and the hair follicle led to the biomarker programme using plucked hair. Matthew Walls, CEO of EpiStem told DrugResearcher.com that very finite changes in gene expression in hair follicles correspond well with what is happening in the rest of the body during chemotherapy. Plucked human hairs are taken at various times during cancer treatment. The DNA in the hair is amplified using real-time PCR and gene activity is measured through levels of mRNA. Since EpiStem has developed a means to do this assay on a very small scale, very low levels of sample can be used, such as a single drop of blood, as well as hair follicles.
Using this gene expression technology, Walls said that EpiStem has been able to analyse gene expression levels in single cells, for example in the small intestine. This technology has enabled EpiStem to divide its business up over three fronts. It is a preclinical contract research organisation offering services to drug companies involved in therapies for cancer, cancer supportive care and inflammatory bowel disease (IBD). However, EpiStem is also developing an internal pipeline of protein therapies, which could regulate stem cells. These therapies could be used in the same three therapeutic areas. For example, decreasing cell growth in tumours or increasing growth to reduce chemotherapy-related ulcers. Walls explained that because the biological drugs would be specific to a given type of endothelial tissue, up-regulating cell growth through stem cells wouldn't cause a tumour in other tissues to also grow. The thrid area of the business is in the already mentioned field of biomarkers, which will be used in both internal and external research programmes.
This latest deal with AstraZeneca works well for both companies; not only does AstraZeneca get to guide its drug development but EpiStem also gets the benefit of one of the world's biggest pharma companies validating its technology. "The ability to use minimally invasive biomarkers to help guide our preclinical and clinical drug development is an important step forward for AstraZeneca's drug development programme," said Brent Vose, vice president of AstraZeneca's oncology therapy area. "We have been impressed by the 'plucked hair' biomarker technology and look forward to working closely with EpiStem Plc in the successful delivery of our joint feasibility studies."