Angle PLC Announces Submission Accepted by FDA for Substantive Review

Rhea-AI Summary

ANGLE plc has successfully completed the FDA's administrative review for its Parsortix system, seeking clearance for use with metastatic breast cancer. The full Class II De Novo submission aims for FDA clearance potentially by Q2 CY21. This submission follows five years of development and extensive documentation. The FDA has 150 days to make a decision post-submission acceptance. ANGLE's technology has the potential to be the first of its kind to capture intact circulating tumor cells from blood for analysis, marking a significant advancement in non-invasive cancer diagnostics.

Positive

• Successful completion of FDA's administrative review for the Parsortix system.
• Potential for FDA clearance by Q2 CY21.
• Five years of extensive development contributing to the submission.
• Possible first-ever FDA clearance for a platform capturing circulating tumor cells.

Negative

• Inherent uncertainty regarding timing and success of the De Novo process.

• Full Class II De Novo FDA Submission seeking clearance of the Parsortix system for metastatic breast cancer has successfully completed FDA administrative review
• ANGLE believes that the earliest prospect of FDA clearance is Q2 CY21*

GUILDFORD, SURREY / ACCESSWIRE / October 20, 2020 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that FDA has completed its administrative review and accepted ANGLE's FDA submission for substantive review.

As announced on 28 September 2020, ANGLE has submitted a full Class II De Novo FDA Submission for its Parsortix^® PC1 system seeking FDA clearance for use with metastatic breast cancer (MBC) patients ("the Submission"). ANGLE has now received an Acceptance Review Notification from FDA that the Submission has been accepted. The administrative acceptance review is a formal process undertaken by FDA to determine that the Submission contains all of the necessary elements and information needed by FDA to proceed with substantive review.

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 been submitted to FDA.

FDA's goal is to make a decision about a De Novo request in 150 review days. Review days are calculated as the number of calendar days between the date the De Novo request was received by FDA and the date of FDA's decision. The review clock stops, however, when FDA requests further information or clarification from the Company. ANGLE believes that the earliest prospect of FDA clearance is Q2 CY21.*

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We are pleased that our FDA submission has successfully completed FDA administrative review and is now in substantive review. 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."

* ANGLE is following a De Novo FDA process for Parsortix, as there is no predicate device. Consequently, there is inherent uncertainty over the timing of the process and its ultimate success.

For further information:

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

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 26 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three extensive families of patents 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 HyCEAD^TM 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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FAQ

What did ANGLE plc announce on October 20, 2020?

ANGLE plc announced that its Class II De Novo FDA submission for the Parsortix system for metastatic breast cancer has successfully completed FDA's administrative review.

What is the significance of the Parsortix system's FDA submission?

The Parsortix system could be the first platform to capture intact circulating tumor cells from blood, potentially transforming metastatic breast cancer diagnostics.

When does ANGLE expect FDA clearance for the Parsortix system?

ANGLE believes the earliest prospect of FDA clearance is Q2 CY21.

What are the next steps after the FDA's acceptance of ANGLE plc's submission?

The submission will undergo substantive review by the FDA, which typically takes 150 days, unless additional information is requested.