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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - OncoMasTR (OncoMasTR - Novel Prognostic Assay for Early Stage Breast Cancer)

Teaser

Summary

Breast cancer is the most frequently diagnosed cancer in women (25%) with 1.6 million new cases annually worldwide and increasing by around 1.5% each year. Due to the advent of mammographic screening across the EU and worldwide over the last 30 years, the majority of newly diagnosed breast cancers are early stage, hormone receptor-positive (ER+), lymph node-negative (LN-) cancers (i.e. not spread beyond the breast). These patients usually undergo surgery to remove the tumour, followed by chemotherapy to remove any remaining tumour cells in their system to prevent recurrence of the disease. Whether or not to subject these patients to additional chemotherapy is an ongoing problem for clinicians. Besides the temporary effect on quality of life due to chemotherapy (nausea, hair loss, diarrhoea, constipation, appetite changes, sore mouth and eyes), there is an increased risk of death due to treatment alone, and also an increased risk of future cancer. It is estimated that 30% of women with early stage disease will go on to develop a recurrence after surgery, meaning that up to 70% of women with early stage breast cancer are treated with chemotherapy, despite not benefiting from such treatment, thereby exposing these individuals to severe side effects.
OncoMark Ltd are developing a novel breast cancer assay, called OncoMasTR, which has the potential to transform clinical practice and patient care. The OncoMasTR assay will help clinicians to determine which patients should not receive chemotherapy for early stage breast cancer thus avoiding unnecessary chemotherapy. The OncoMasTR assay identifies those patients at low risk of recurrence which will greatly reduce the numbers receiving chemotherapy but will not increase the risk of recurrence. Reducing the number of patients receiving cancer-related treatments will reduce the requirements for healthcare provision (doctors, nurses and hospital beds) and reduce economic hardship for patients who routinely lose working days due to chemotherapy-induced side effects. OncoMasTR will be a CE marked kit that can be used in hospital laboratories, and penetrate a global market. The OncoMasTR assay is more cost effective that the leading competitor assays and has markedly better performance than the market leaders.

Work performed

For the OncoMasTR assay to be used by clinicians in hospital laboratories, it has to progress through 3 steps of product development; analytical validation, clinical validation/benchmarking and regulatory approval. Work during the first period of this project focussed on the analytical validation of the OncoMasTR assay yielding an initial prototype assay. In Period 2, the OncoMasTR test was demonstrated to be analytically robust and suitable for deployment in routine clinical laboratories. In Period 2, clinical validation was carried out in both the BC Blood cohort and the TransATAC cohort, the most comprehensively studied cohort of early stage breast cancer patients in the world. This provided the first level 1B validation study for the OncoMasTR assay and preliminary analysis has demonstrated that the OncoMasTR signature is significantly prognostic for distant metastasis with performance at least as good as competitor tests and can identify a subset of early stage breast cancer patients that can safely forgo chemotherapy. Also, in Period 2, a benchmarking study of OncoMasTR against Oncotype DX, a leading competitor, was carried out in the TAILORx cohort to compare risk stratification. This study is scheduled to be completed in March 2018.
Parallel to the technical work, we have been working on the commercial development of the OncoMasTR assay to ensure that the technology is market ready once the product development phase is complete. A business plan was created and presented to potential investors. A total of â‚¬2.1 million was successfully secured. News of the â‚¬2.1 million OncoMark investment was disseminated through a press release which featured in a large number of national and international publications. We are currently progressing a patent application, entitled â€˜A method of predicting risk recurrence of cancerâ€™, which was filed in August 2014 to ensure that we have IP protection in all countries that we enter, without impinging on other patents.
We have engaged with key opinion leaders (KOLs) to disseminate the benefits of the OncoMasTR technology over competitors. Extensive communication and dissemination activities were carried out by the OncoMark team. We presented posters detailing the development and validation of OncoMasTR at two conferences; ESMO in September 2017 and SABCS in December 2017. We also continued to disseminate OncoMark news through the website and social media platforms. OncoMarkâ€™s CEO, Mr. Des Oâ€™Leary has received two awards over the course of the grant; an award for best pitch in the Health field at the SME Instrument Innovatorâ€™s Summit in October 2016 and an Ireland\'s Champions of EU Research award from Enterprise Ireland in June 2017. In February 2017, OncoMarkâ€™s CSO Prof. William Gallagher, was the inaugural recipient of the Irish Association of Cancer Research (IACR) Cancer Research Medal which recognised his outstanding contribution to the cancer research community in Ireland.
Project website: www.OncoMasTR.com

Final results

The OncoMasTR assay will have a positive impact on:
Patientsâ€™ needs: A key need for patients is to avoid unwarranted chemotherapy, where possible. Chemotherapy causes a diminished quality of life due to a series of side effects and confers a risk of death. The OncoMasTR assay identifies the patient population at low risk of recurrence. Therefore, this will greatly reduce the numbers receiving chemotherapy but will not increase the risk of recurrence. Treatment can also cause economic hardship for the patient, resulting from lost workdays due to chemotherapy-induced sickness. The OncoMasTR assay will help to alleviate this hardship for a large number of patients due to better performance than competing assays.
Cliniciansâ€™ needs: There is a clinical need for a more accurate, binary, prognostic test to determine the risk of recurrence for early stage breast cancer patients. Clinicians need a precise test that does not lead to ambiguous results or over treatment. The OncoMasTR assay can meet this need due to its more accurate binary output and better performance than predicate approaches, thereby facilitating better clinical decision making and reducing the number of patients requiring chemotherapy.
Clinical Centre / Hospital needs: Hospitals with limited budgets always need to reduce their operating costs but maintain excellent care for their patients. As there is a growing population of cancer patients, this will increase the requirements for healthcare provision, i.e. chemotherapy units / doctors etc. in hospitals each year. The OncoMasTR assay can better allow clinics to prioritise the higher risk patients for further treatments and care.
Government needs: The overall healthcare cost burdens are increasing annually. For each new diagnostic test or drug therapy, the payers must make decisions about whether they will reimburse such costs. For this, they need demonstrated cost effectiveness to determine if the cost of implementation will offset or decrease the overall costs. With improved risk stratification and lower costs versus competitors, the OncoMasTR assay will be significantly more cost-effective.