Working all the angles

“When the opportunity came our way to work with the University of Vienna, it was exciting for many reasons—for me, it was exciting because their research is a good example of the way our system is enabling new molecular-based cancer information,” Shane Booth, chief technology officer of ANGLE, tells DDNews. “The research has provided very promising preliminary data. Parsortix is enabling the strategic deployment of emerging molecular biology for cancer diagnostics and cancer patient monitoring.”

The Medical University of Vienna poster presentation’s research team, led by Prof. Robert Zeillinger, head of the Molecular Oncology Group, and Dr. Eva Obermayr, principal investigator, sought to develop a protocol that combined the microfluidic Parsortix technology with qPCR to enable the molecular analysis of CTCs implicated in ovarian and breast cancer. Using this approach, Obermayr, Zeillinger and colleagues achieved significantly higher ovarian cancer detection rates (80 percent and 78 percent, versus 24 percent for other CTC approaches) when screening against a proprietary seven-gene panel. For the detection of breast cancer, the researchers also demonstrated an improved detection rate, finding as high as 71 percent mRNA-positive patients versus 40 percent for the standard CTC diagnostic approach, which relies on the expression of epithelial markers.

The system was further optimized with the addition of 23 RNA markers. In the initial subset of study samples so far analyzed, this approach identified an increased detection level of 92 percent across all the cancer types, with 100 percent of the ovarian cancer patients correctly identified while maintaining 100-percent specificity. Larger sample sizes will be needed to confirm these optimized results.

“The Parsortix technology contributes to the unprecedented specificity of the overall approach, by providing a high-purity CTC sample. Parsortix is a label-free technology, and as such may become the gold standard for ovarian cancer diagnosis,” said Obermayr. “By combining the Parsortix technology with qPCR analysis, we achieved an unprecedented high detection rate of cancer, even in early-stage patients, when conventional diagnostic methods failed.”

The Medical University of Vienna is now progressing into a multicenter prospective clinical study in ovarian cancer, which is expected to take around 18 months to complete. ANGLE is supporting this effort as a top priority. The Parsortix system, together with the RNA marker panel, has the potential to help inform clinical decision-making for ovarian cancer patients in detection, therapy monitoring and remission monitoring.

Following the early results of the ovarian cancer research from the Medical University of Vienna, ANGLE raised £8.8 million (about $13.1 million) in February through a placing of additional shares and offer of new shares to existing stockholders. The money raised will be used to drive the commercialization of an ovarian cancer diagnostic on the Parsortix platform.

“The prospect of a simple blood test for cancer with high sensitivity and specificity is unheard of in the medical field,” said Andrew Newland, ANGLE’s founder and chief executive. “The very strong substantiation of the Parsortix system coming so soon after our fundraising is very welcome. We continue to focus all our efforts to get this system into the market to the benefit of patients.”

While initial commercial development of the Parsortix system is focused on ovarian cancer, Newland informs DDNews that the Parsortix system has promising results in the capability to detect all cancers with solid tumors of epithelial origin—as well as other diseases—that require the capture and isolation of specific cells from a blood sample to aid in analysis for diagnosis. “Parsortix is enabling precision medicine, preventing waste and empowering the targeting of personalized treatments and drugs to each patient, as well as being much less invasive,” says Newland.

The Barts Cancer Institute of Queen Mary University of London and Thomas Jefferson University have also released poster presentations that use ANGLE’s Parsortix cell separation system. The Barts Cancer Institute has released a presentation detailing Parsortix’s effectiveness in detecting prostate cancer, and Thomas Jefferson University has released research on the Parsortix system’s selective isolation of CTCs for downstream molecular analysis of a highly enriched population of single cells, irrespective of expression technique.

“Our strategy with Parsortix has been to collaborate alongside multiple cancer centers. They can investigate, and we are able to provide the technology and tech support,” Newland explains. ANGLE is also working with University of Southern California’s Norris Comprehensive Cancer Center and MD Anderson, as well as the aforementioned universities.

ANGLE hopes to be able to bring the Parsortix system to the general medical market as soon as 18 months from now, pending multiple studies in the United States and European Union.

“We are in process of seeking authorization with the FDA. At the moment, there is no other system filtering cancer out of the blood cells, and we’re hoping to be the first to patient,” says Newland.