Full Class II De Novo FDA Submission seeking clearance of the Parsortix system for metastatic breast cancer
Potential to be the first ever FDA clearance for a system to harvest intact cancer cells from a simple blood draw for subsequent analysis
GUILDFORD, SURREY / ACCESSWIRE / September 28, 2020 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that it has submitted a full De Novo FDA Submission for its Parsortix® PC1 system seeking FDA clearance for use with metastatic breast cancer (MBC) patients ("the Submission").
The Submission provides a data package demonstrating the performance of the Parsortix system in harvesting cancer cells from MBC patient blood for subsequent analysis. The directors believe that the capability to harvest these cells provides the potential for a wide range of downstream analyses, which may transform the treatment of cancer, providing patients with personalised cancer care through a non-invasive, repeat biopsy based on a simple blood test (a "liquid biopsy").
Submission details
The Submission is the output of five years' work including extensive dialogue with FDA, and the development of over 400 technical reports and documents, which have now been submitted to FDA. The characterisation of the system included the assessment, inter alia, of performance with clinical samples, recovery, linearity, limit of detection, reproducibility, repeatability, blood volume, blood stability and interfering substances both exogenous and endogenous, requiring over 15,000 samples to be run on the Parsortix system in the UK and at clinical sites in the United States. This process, combined with the manufacture of the Parsortix system and associated consumables, has been completed and fully documented under ANGLE's ISO 13485 quality system and in compliance with numerous other technical and quality standards active in the United States and Europe. The Submission has also been designed to meet the requirements for European CE Mark and, if granted clearance by FDA in the United States, ANGLE intends to register for European CE Mark clearance allowing clinical sales in both the United States and Europe for the intended use.
We are most grateful to over three hundred MBC patients at four leading US cancer centres and several thousand healthy volunteer donors, who have donated blood to allow us to undertake the extensive studies necessary for the Submission.
Market potential
ANGLE intends that the Parsortix system will eventually be adopted worldwide. Cowen Equity Research estimate the market opportunity for liquid biopsy in the United States alone to be up to US$ 130 billion per annum.
The current National Cancer Guidelines in the United States for the treatment of MBC patients require a tissue biopsy of the metastatic site to support clinical decision-making. Despite being in the Guidelines, only around 50% of MBC patients receive a successful biopsy as a result of patients being too sick for the invasive procedure, the inaccessibility of the metastatic site or insufficient tissue being available. For the same reasons, virtually no MBC patients will subsequently have a further biopsy of another metastatic site, despite it being well-established that cancer develops and changes over time and there is a clear medical need for up-to-date information on the status. The Parsortix system offers an alternative method for obtaining cancer cells for analysis, which is non-invasive and can be repeated as often as needed. Furthermore, unlike ctDNA (fragments of dead cells) analysis, the focus for most of the liquid biopsy industry, which is limited to DNA, a full range of analyses can be undertaken with circulating tumor cells (CTCs) harvested by the Parsortix system including DNA, RNA and protein analysis making it a close parallel to the tissue biopsy.
Breast cancer is the most frequently diagnosed cancer in women in the United States and there are an estimated 3.6 million women alive who have been diagnosed with breast cancer in the United States. Despite new treatment options and advances in patient management protocols, an estimated 30% of women initially diagnosed with earlier stages of breast cancer eventually develop recurrent advanced or metastatic disease. Although the prognosis of patients with metastatic breast cancer has significantly improved over the last two decades, it remains largely incurable with median survival of three years. ANGLE estimates that the global market potential for the Parsortix system used with MBC patients is US$2.4 billion per annum.
COVID-19
During lock down, 'non-essential' screening, surgical and other procedures for cancer treatment have been postponed, delayed or cancelled by clinical institutions across the world. This extends to procedures such as tissue biopsies both of primary cancer sites for diagnosis and secondary cancer sites for treatment selection. The delay of these procedures may have significant adverse impacts for patients. This highlights the need for the regulatory approval of a CTC based liquid biopsy alternative to such invasive tissue biopsy procedures. Harvested cancer cells from a simple blood test that could be used to progress a patient's diagnosis and treatment while reducing the time to answer delays associated with the processing and pathological evaluation of tissue biopsies would be extremely valuable. The blood draw could be undertaken at the patient's home avoiding the need for the patient to visit the clinical institution for a surgical procedure.
De Novo process
ANGLE is following a De Novo FDA process for Parsortix as there is no identified predicate device. Consequently, there is inherent uncertainty over the timing of the process and its ultimate success. The outcome and timing of any FDA regulatory decision is entirely dependent on FDA's review and response to the Company's submission. ANGLE considers the earliest likely timing for clearance is six months after submission.
ANGLE Founder and Chief Executive, Andrew Newland, commented:
"We are delighted to have made our FDA Submission for the Parsortix system. We believe there is a tremendous opportunity for ANGLE to secure the first ever FDA clearance for a platform that captures and harvests intact circulating tumour cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer. We believe that FDA regulatory clearance, considered the gold standard for approval of medical diagnostic systems globally, would further competitively differentiate our Parsortix liquid biopsy system and should lead to an acceleration in commercial adoption of the system in both research and clinical settings."
For further information ANGLE:
ANGLE plc
+44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
finnCap Ltd (NOMAD and Joint Broker)
Corporate Finance – Carl Holmes, Simon Hicks
ECM – Alice Lane, Sunila de Silva
+44 (0)20 7220 0500
WG Partners (Joint Broker)
Nigel Barnes, Nigel Birks, Andrew Craig, Chris Lee
+44 (0) 203 705 9330
FTI Consulting
Simon Conway, Ciara Martin, Stephanie Cuthbert
Matthew Ventimiglia (US)
+44 (0) 203 727 1000
+1 (212) 850 5624
The information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2015.
For Frequently Used Terms, please see the Company's website on https://angleplc.com/investor-relations/glossary/
Notes for editors
About ANGLE plc www.angleplc.com
ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected platforms include a circulating tumor cell (CTC) harvesting technology and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins.
ANGLE's cell separation technology is called the Parsortix® system, and it enables a liquid biopsy (a simple blood test) to be used to provide the cells of interest to the user in a format suitable for multiple types of downstream analyses. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all types of CTCs as well as CTC clusters in a viable form (alive).
CTCs enable the complete picture of a cancer to be seen as, being an intact cell, they allow DNA, RNA and protein analysis and thus provide comparable analysis to a tissue biopsy. Because CTC analysis is a non-invasive process, unlike tissue biopsy, it can be repeated as often as needed. This is important because cancer develops and changes over time and there is a clear medical need for up-to-date information on the status. In addition, the live CTCs harvested can be cultured, which offers the potential for testing response to drugs outside the patient.
The Parsortix technology is the subject of 24 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three extensive families of patents are being progressed worldwide.
The Parsortix system has a CE Mark in Europe for the indicated use and, in the United States, a De Novo Submission has been made to FDA for the Parsortix® PC1 system seeking FDA clearance with Class II Classification for use with metastatic breast cancer patients. FDA clearance is seen as the global standard. ANGLE is seeking to be the first ever FDA cleared system for harvesting CTCs for subsequent analysis.
ANGLE has also completed two separate 200 subject clinical studies under a programme designed to develop an ovarian cancer pelvic mass triage test, with the results showing best in class accuracy (AUC-ROC) of 95.1%. The pelvic mass triage assay has undergone further refinement and optimisation, and is currently in the process of a 200 patient clinical verification study.
ANGLE's technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEADTM Ziplex® platform and is based on a patented flow through array technology. It provides for low cost, highly multiplexed, rapid and sensitive capture of targets from a wide variety of sample types. A proprietary chemistry approach (the HyCEAD method) allows for the capture and amplification of over 100 biomarkers simultaneously in a single reaction. The HyCEAD Ziplex system is extremely sensitive and is ideal for measuring gene expression and other markers directly from Parsortix harvests and was used in the ovarian cancer pelvic mass triage test to achieve best in class accuracy (AUC-ROC) of 95.1%.
ANGLE's proprietary technologies can be combined to provide automated, sample-to-answer results in both centralised laboratory and point-of-use cartridge formats.
ANGLE has established formal collaborations with world-class cancer centres and major corporates such as Abbott, Philips and QIAGEN, and works closely with leading CTC translational research customers. These Key Opinion Leaders (KOLs) are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies. The body of evidence as to the benefits of the Parsortix system is growing rapidly from our own clinical studies in metastatic breast cancer and ovarian cancer and also from KOLs with 36 peer-reviewed publications and numerous publicly available posters, available on our website.
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SOURCE: ANGLE plc
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