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The problem and need

Cancer Research UK‘s statistics suggest that men have a 45% likelihood of suffering from cancer during their life. Women are only slightly lower at 41%. During treatment for the disease, particularly the secondary (metastatic) disease, there are many challenges which can often arise leaving both Physicians and patients with unanswered questions such as:

• How does the clinician know which drug will work most effectively on a patient?
• How does the clinician track whether drugs are in fact working and having a positive impact?
• How do clinicians monitoring patients in remission assess any risk of the disease returning?

The challenges in treatment listed above may become further complicated due to the fact that some forms of the disease may change or evolve over time. This means that a drug that was once ineffective during an early stage of treatment may prove to become effective in treating the disease at a later time; and vice versa.

In order to treat patients effectively, it is necessary for doctors to employ drugs that target the individual patient’s cancer at that point in time. This approach is called “personalized cancer care” and in recent years it has become accepted worldwide as the most likely way to improve a patient’s long-term care.

The globalization of this approach to treatment has fostered a crucial need among clinicians for ongoing and updated information as to a patient’s cancer status. Primary tumors will be completely removed if possible and hence repeat biopsy is not an option. Biopsy of secondary disease sites tends to be far more difficult, invasive and costly.

Circulating Tumor Cells and the Parsortix™ solution

Solid tumor cancers, such as breast cancer and prostate cancer, shed cancer cells into the patient’s blood stream.

These are cells are known as Circulating Tumor Cells (CTCs). CTCs are very rare, perhaps representing a single cell in one billion blood cells, and are thus very difficult to isolate. They are, however, extremely valuable cells due to several defining features:

• They contain information on the type of disease – which has the potential to inform on “personalized” care decisions and targeted drug therapies
• Their presence and quantity has been shown to be indicative of patient prognosis
• They are very likely to be the route by which primary (localised) tumors spread around the body so resulting in metastatic disease.

The Parsortix™ system from ANGLE is able to capture and harvest CTCs from patient blood. This means that a simple peripheral blood test could be used to provide crucial medical information regarding the fluctuating status of a patient’s disease.

It is widely agreed that such a “liquid biopsy” would have a profound impact in understanding the patient’s current cancer status as well as ensuring the optimum treatment is deployed for that individual patient at that particular time.

Market Size

ANGLE’s ultimate objective is the widespread adoption of the Parsortix™ system system into scholarly institutions and treatment centers which specialize in the diagnosis and treatment of cancer patients. According to the World Health Organization, there were an estimated 14 million new cancer cases worldwide in 2012, a marked rise on the 12.7 million cases in 2008. In 2012, there were an estimated 32.6 million people living with cancer. (Source: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx)

The incidence of cancer continues to grow as a result of demographic, lifestyle and environmental factors and it is estimated that one in three people in the UK will get cancer during their lifetime.

There are a wide range of potential applications for harvested CTCs including diagnosis, prognosis, mutational analysis and drug selection, drug development, assessment of treatment effectiveness, and remission monitoring. We estimate that this represents a potential global market for ANGLE’s Parsortix™ system worth in excess of £8 billion per annum.

ANGLE’s major focus is on the cancer market. There is also a substantial market available in the field of non-invasive fetal diagnostics, which involves harvesting fetal cells from the pregnant mother and analysing for Down’s Syndrome and many other chromosomal and genetic conditions through a simple blood test.

Strategy

ANGLE has a clear strategy to commercialise its Parsortix™ technology.

The cell capture and harvesting technology consists of a cell separation cassette together with an automated system to run blood samples through the cassette. There is extensive intellectual property protection around key elements of the system.

Successful evaluation of the system by major cancer research centres has already been achieved and a major part of ANGLE’s current efforts relate to further deployment with key opinion leaders in the field.

Regulatory authorization for the clinical use of the system is currently CE Marked while the process of FDA clearance has been initiated and is currently ongoing in the USA.

Widespread adoption of the Parsortix™ system in the clinical market is crucially dependent upon how information about the product is presented to key opinion leaders. In order to reach this goal, we aim to:

• Undertake pilot studies assessing clinical applications for CTCs. Select the most promising applications
• Undertake larger patient studies providing fully documented evidence of how the system should be used for particular patient applications in routine treatment
• Convert key opinion leader support and peer reviewed publications into widespread adoption of the Parsortix™ system in routine patient care