ANGLE plc has announced successful results from its Parsortix liquid biopsy system in a Phase 2 pilot study conducted with pharmaceutical company Eisai. The study demonstrated the system's capability to assess breast cancer patients' HER2 status in real-time, offering significant advantages over traditional tissue biopsies.
The UK-based liquid biopsy company reported that its Parsortix-based HER2 assay successfully processed patient samples with consistent results at each timepoint. Notably, the technology detected significant differences in HER2 circulating tumor cell (CTC) status, as well as changes in CTC numbers and clusters, between pre-treatment and post-treatment samples from the same patients.
"This data is highly significant as it validates that ANGLE's HER2 assay is capable of measuring changes in HER2 status over time, which is not possible with a tissue biopsy as it is an invasive procedure which cannot always be repeated," the company stated in its announcement.
Implications for Breast Cancer Treatment
The ability to monitor HER2 status dynamically could have profound implications for breast cancer treatment. HER2 (human epidermal growth factor receptor 2) is an important biomarker that determines eligibility for targeted therapies, including antibody-drug conjugates (ADCs).
Andrew Newland, ANGLE's Chief Executive Officer, highlighted the potential clinical impact: "There is considerable evidence, including ANGLE's in-house studies, that demonstrate that HER2 status of patients can change over time, with HER2 positive CTCs being found in patients who were initially HER2 negative based on their tissue biopsy."
This observation is particularly significant as independent studies have shown that patients with HER2-positive CTCs can benefit from HER2-targeted treatments, even when their initial tissue biopsy indicated HER2-negative status. This could potentially expand the market for HER2-targeted drugs while improving outcomes for patients who would otherwise not receive such treatments.
The HER2 therapeutic market is substantial and growing, valued at approximately $9.4 billion in 2023 and projected to reach $13.2 billion by 2030. Last year saw a record 481 new ADC trials announced, with HER2 being the leading target candidate.
AstraZeneca Assay Development Success
In addition to the Eisai study results, ANGLE announced the successful completion of development work for AstraZeneca on two important assays:
- A Parsortix-based Androgen Receptor (AR) assay for prostate cancer
- A DNA damage response (DDR) assay for detecting micronuclei in CTCs as a measure of DNA damage
Both assays have been approved for use by AstraZeneca and are currently being used to test patient blood samples. This positions ANGLE to execute large-scale clinical trials for AstraZeneca and potentially expand CTC analysis to other areas within the pharmaceutical company's research portfolio.
"Successful completion of the AstraZeneca assay development projects is a key milestone for the Company in progressing our aim for Parsortix-based CTC analysis to be widely adopted for new and existing drugs to identify the right drug for the right patient at the right time," said Newland.
Market Opportunities
ANGLE will now add the AR and DDR micronuclei assays to its menu of validated tests available to pharmaceutical customers through its clinical laboratory services. Both markets present significant opportunities:
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The AR therapeutic market is estimated to reach $9.2 billion by 2033, driven by increasing prostate cancer prevalence and growing demand for personalized medicine. Currently, over 46,000 patients are enrolled in 181 AR clinical studies.
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The DDR therapeutic market was valued at $8.2 billion in 2024 and is forecast to grow to $30.3 billion over the next decade. With more than 16,000 patients in 133 DDR clinical trials, ANGLE sees substantial opportunity in this space.
Future Directions
While the full Phase 2 study of Eisai's HER2-targeting antibody-drug conjugate BB-1701 has not yet completed, Eisai has decided not to progress its option for BB-1701 and has returned product development rights to BlissBio. Despite this, ANGLE reports having developed a good working relationship with Eisai, which has indicated interest in using Parsortix-based CTC analysis for other projects.
ANGLE is now seeking to engage with BlissBio to support the next stage of BB-1701 development, although specific details are not yet available.
The Parsortix system has been cleared by the FDA for enriching circulating tumor cells from peripheral blood collected from patients diagnosed with metastatic breast cancer. The technology employs a microfluidic chamber to capture cells based on size and deformability, enabling downstream analysis including whole cell imaging and molecular characterization.
With over 100 peer-reviewed publications demonstrating the performance of the Parsortix system, ANGLE continues to position its liquid biopsy technology as a valuable tool for research, drug development, and clinical oncology applications that could significantly improve cancer treatment through more personalized approaches.
