OCB Launches ToxNav in the UK Market

Oxford Cancer Biomarkers launches ToxNav to improve morbidity and mortality rates in patients undergoing CRC chemotherapy

Oxford, UK, 28 June 2018: Oxford Cancer Biomarkers Limited (www.oxfordbio.com) has announced the launch of ToxNav – a genomic test to identify cancer patients at high risk of severe and potentially fatal side-effects when treated with 5FU/Capecitabine chemotherapy. ToxNav helps clinicians to select safer chemotherapy regimens, thereby reducing both the likelihood of life-threatening toxicity and unnecessary treatment costs. Initially available for colorectal cancer, the company plans to develop ToxNav for other cancers for which 5FU/Capecitabine is the first-line chemotherapy.

Colorectal cancer (CRC), is the fourth most common cancer in the UK and a significant number of CRC patients are genetically predisposed to severe side-effects from 5FU/Capecitabine chemotherapy. Side-effects include neutropenic sepsis, diarrhoea, nausea/vomiting, stomatitis, mucositis, and hand-foot syndrome, which reduce quality of life and come at a high financial cost to the NHS. Data suggests that 30,000 CRC patients undergo 5FU/Capecitabine therapy each year in the UK. Of these up to 9,000 (10-30%) people will suffer severe side effects related to toxicity and at least 3,000 (10%) are likely to go to hospital. An evidenced mortality rate of 1% of all 5FU/Capecitabine-treated CRC patients means that 300 people each year in the UK will die from their treatment.

The CE-marked ToxNav test analyses the patient’s DNA, from a sample of venous blood, for genetic mutations in a proprietary panel of 21 variants shown in studies to be associated with 5FU/Capecitabine toxicity. OCB then provides a report to the oncologist describing a risk classification for the patient, allowing chemotherapy to be specifically tailored for that individual.

OCB’s Founder, Professor David Kerr, CBE, Professor of Cancer Medicine at the University of Oxford and one of the UK’s leading CRC specialists commented: “The burden of chemotherapy-associated toxicity is well recognised. Until now, the tools and guidelines for increasing the precision of anticancer drug prescribing have been limited to genomic tests based on 5 genetic variants. Through exhaustive research we have developed ToxNav, based on a superior panel of 21 genotypic variants which provide much greater sensitivity and specificity in the prediction of adverse toxicity events, which has been validated in almost 900 CRC patients.”

Oxford Cancer Biomarkers was established in 2012 to provide healthcare practitioners with improved knowledge to enhance clinical decision-making in the treatment of cancers. David Browning, OCB’s CEO said: “Oxford Cancer Biomarkers has a portfolio of genomic biomarker tests in various stages of development, which all follow our mission of improving the standard of cancer care based on the strongest clinical validation. ToxNav for colorectal cancer is the first of these products to be launched in the UK ahead of launch in other countries. As well as exploring ToxNav’s clinical utility in other cancer types such as breast and prostate for which 5FU/Capecitabine is the established first line therapy, we are developing diagnostic tests to identify CRC patients that require chemotherapy and that measure the lifetime risk of developing the disease. All our tests are designed to improve the treatment and prognosis for cancer patients, and at the same time making treatment more cost-effective for healthcare providers.”

For more information please visit the Oxford Cancer Biomarkers website at www.oxfordbio.com.

References

1. Kerr et al., Adjuvant capecitabine plus bevacizumab versus capecitabine alone in patients with colorectal cancer (QUASAR 2): an open-label, randomised phase 3 trial. Lancet Oncol 2016; 17(11): p. 1543-1557.
2. Loganayagam et al., Pharmacogenetic variants in the DPYD, TYMS, CDA and MTHFR genes are clinically significant predictors of fluoropyrimidine toxicity. British Journal of Cancer 2013; 108: 2505–2515.
3. Meulendijks et al., Clinical relevance of DPYD variants c.1679T>G, c.1236G>A/HapB3, and c.1601G>A as predictors of severe fluoropyrimidine-associated toxicity: a systematic review and meta-analysis of individual patient data, Lancet Oncol 2015; 16 (19): 1639-50.
4. Rosmarin et al., Genetic Markers of Toxicity From Capecitabine and Other Fluorouracil-Based Regimens: Investigation in the QUASAR2 Study, Systematic Review, and Meta-Analysis, J Clin Oncol 2014; 32 (10): 1031-39.
5. Church et al. ‘Toxgnostics’: an unmet need in cancer medicine. Nat Rev Cancer. 2014; 14(6):440-5.
6. Rosmarin et al., A candidate gene study of capecitabine-related toxicity in colorectal cancer identifies new toxicity variants at DPYD and a putative role for ENOSF1 rather than TYMS. Gut. 2015; 64(1):111-20.
7. NHS Five Year Forward View, October 2014. https://www.england.nhs.uk/wp-content/uploads/2014/10/5yfv-web.pdf.
8. Amstutz et al., Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for Dihydropyrimidine Dehydrogenase Genotype and Fluoropyrimidine Dosing: 2017 Update Clin Pharmacol Ther, 2018; 103 (2):210-16.
9. ESMO 2018 abstract: Palles et al., An evaluation of the clinical utility of a panel of variants in DPYD and ENOSF1 for predicting common Capecitabine related toxicities.

Editors’ Notes

About Oxford Cancer Biomarkers

Oxford Cancer Biomarkers translates ground-breaking scientific discovery into predictive biomarker diagnostic products that allow medicines to be personalised for the benefit of the cancer patient. Oxford Cancer Biomarkers is a spin-out of the University of Oxford and has strong links with the Medical Sciences Division in Oxford University. The company was founded by Nick La Thangue, Ph.D., Chair of Cancer Biology at Oxford University and David Kerr, CBE, D.Sc., M.D. FMedSci, Professor of Cancer Medicine at Oxford University. Investors in OCB include Longwall Venture Partners LLP, Esperante BV, Ningbo My-BioMed Biotechnology Co.,Ltd., CancerRop Co. Ltd., and the University of Oxford.