Angle Outlines Strategy As It Nears Major Regulatory Announcements
Executive Summary
With approvals looming over the next few months, Angle spoke to Medtech Insight to probe deeper about its presentation at the 2021 Jefferies Healthcare Conference.
Angle’s core strategy is “all about getting the best sample,” Angle CEO Andrew Newland explained at the 2021 Jefferies Healthcare Conference on 17 November.
“Cancer is heterogenous; it’s dynamic,” he said, explaining that for each individual patient, their disease will progress at different rates, with different side effects. “Each patient’s cancer is different from the next, and it changes over time.”
“When treatment starts to fail … and the earlier tissue biopsy is old, doctors end up flying blind,” he said. “A lot of money is wasted on drugs that don’t work and patients die. You really want to be able to repeat the biopsy, get some more cancer cells and study them.”
To get these new cells, physicians can sometimes perform a second tissue biopsy. However, if the tumor lumps were totally removed, it is unlikely that any more cancer cells would be found. Moreover, some patients are too sick to undergo a further surgery.
"Well over 90% of patients who die of cancer die from secondary cancer. If you could get a hold of these cells, they could be studied to get all the information needed about the cancer’s spread, and what drugs to use against it.” – Andrew Newland
“The answer to this has been known for fifty years,” Newland explained. “Cancer spreads via the circulatory system. Cells in the blood vessels can land somewhere else and start a secondary cancer in the patient. Well over 90% of patients who die of cancer die from secondary cancer. If you could get a hold of these cells, they could be studied to get all the information needed about the cancer’s spread, and what drugs to use against it.”
Blood samples, when compared to tumor tissue biopsy, are less invasive. They can be repeated and are unlikely to lead to serious complications. This is the greatest advantage of Angle’s Parsortix system, a tool for capturing circulating tumor cells (CTCs) within the blood for analysis, according to Newland. Most comparable diagnostic systems search for circulating tumor DNA, but Parsotix captures whole cells so it can gather more information about the cell from its full DNA, RNA and protein expression.
Parsortix uses microfluidics technology developed in the early 2000s to capture these cells. A higher CTC count in a sample is indicative of a more aggressive tumor that is likely to spread. (Also see "Angle Is Ready To Capitalize On Promise Of Capture Cell Technology" - Medtech Insight, 1 Oct, 2021.)
Parsotix uses blood-sample cassettes that contain patented microchannel technology. The blood moves through a series of progressively smaller steps to reach a critical gap. CTCs are bigger than this critical gap so they end up being trapped and the rest of the blood passes through. These CTCs can then be washed out for analysis, which provides information about the patient’s cancer. Parsotix can run multiple analyses to track a patient's disease trajectory.
Opportunity Is Near
Angle is well on its way to receiving approvals for its system in a range of different cancer applications.
“We have a laboratory developed test for clinical use looking at ovarian cancer,” explained Newland. Results from a clinical study assessing its efficacy are expected by the end of this calendar year, he told Medtech Insight.
Another clinical partner is an undisclosed company with a “phase three prostate cancer treatment.”
“Prostate cancer is an important area for us to invest in – it's the most common male cancer,” said Newland. “60% of cases are indolent, and yet patients have invasive treatment. Parsortix could show whether a tumor is clinically significant or not.”
“The ideal scenario for us would be to have a whole series of different corporate partnerships with multiple different players where they get access for different cancer types or different uses within each cancer.” – Andrew NewlandAngle has labs based both in the UK, and America, so it is prepared to pursue clinical and commercial opportunities on both sides of the Atlantic.
The company is also “anticipating a regulatory decision by the end of the year” for its metastatic breast cancer test – a use case of Parsortix that arose following the FDA explaining to Angle that it would be “easier for them [the FDA]” to approve, Newland said. That application is “progressing well.”
These imminent approvals are drawing renewed attention from possible partners in the pharma sector. “Commercialization is about collaboration,” said Newland in his presentation, explaining that Abbott is an interested party.
Currently, the standard of care for women presenting with breast cancer is for them to be given a test for the HER2 gene – a market which Abbott currently leads in terms of sales. If the test is positive, the patient will be prescribed trastuzumab.
However, women’s levels of HER2 change over time, so if repeat biopsy is not possible, clinicians will not be able to make further decisions about whether to prescribe the drug. Angle’s technology resolves this problem. By testing the blood, checks for HER2 can be run again and again, as needed. “Abbott will have exclusivity for that one specific use in that one specific cancer. It’s a very segmented approach to commercialization but will quadruple – at minimum – the number of tests they sell for HER2. It also allows us [Angle] to have access to Abbott’s sales and distribution models.”
A Wide Range Of Options
Newland explained that “there’s all sorts of companies that offer downstream testing of cancer tells, and all of them can benefit from getting cancer cells from blood because they can then repeat their tests.”
Angle expects to collaborate with many partners. The pharma services space, Newland pointed out, is worth $1.6bn a year, and Angle has a chance to take significant market share. “The ideal scenario for us would be to have a whole series of different corporate partnerships with multiple different players where they get access for different cancer types or different uses within each cancer.”
This approach is be preferable to being bought out by a single company, Newland said. “Obviously, as a public company, we have to do the best we can for the shareholders as a whole. If a larger company wanted to submit and offer to us, we would have to consider that.”