AGL Angle Plc

ANGLE plc ("the Company")

DNA analysis of Parsortix-enriched CTCs and ctDNA provides complementary information in NSCLC patients treated with AstraZeneca's osimertinib

The addition of CTC-DNA analysis to clinical trials could identify patients developing treatment resistance prior to disease progression

CTC analysis identifies druggable targets which could be used to inform combined targeted treatment

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company with innovative circulating tumour cell (CTC) solutions for use in research, drug development and clinical oncology, is pleased to announce the publication of research investigating the dual analysis of CTCs and circulating tumour DNA (ctDNA) in non-small cell lung cancer (NSCLC), undertaken by the National and Kapodistrian University of Athens.

Researchers used the Parsortix^® system to isolate and harvest CTCs from 30 patients with EGFR-mutated NSCLC that were undergoing treatment with osimertinib (TAGRISSO: AstraZeneca). Osimertinib is an EGFR inhibitor with annual revenues of c. US$6.7 billion, growing at c. 16% per annum. Both CTCs and ctDNA were analysed using a range of molecular techniques which enabled the identification of mutations, methylation, gene expression and amplification.

The study provides further evidence that complementary information can be obtained through dual analysis of CTC-DNA and ctDNA. Using the dual analysis technique, at disease progression an increased number of patients were identified with the EGFR T790M resistance mutation and DNA methylation, compared to analysis of either analyte alone. Dual analysis of these liquid biopsy analytes enables longitudinal monitoring of patients throughout clinical trials and may enable early identification of non-responders and identify patients becoming resistant to treatment before disease progression.

Additional analysis of CTCs identified druggable molecular markers, such as HER2, PD-L1, PIM-1 and AXL, at study baseline and at disease progression, providing information on the potential benefits of combined targeted treatment, and possible suitable therapies for those patients whose cancer progresses due to resistance to osimertinib. This adds to the body of evidence supporting ANGLE's large pharma strategy, highlighting the potential to aid in the stratification of patients that may benefit from alternative/combinatorial therapies being investigated in clinical trials.

Chief Scientific Officer, Karen Miller, commented:

"This study supports our pharma services business by demonstrating how dual molecular analysis of Parsortix-enriched CTCs and ctDNA could improve patient stratification in clinical trials investigating new targeted therapies or new therapy combinations. This approach could ultimately lead to the development of more targeted drugs or better drug combinations that could result in better outcomes for patients, all of which may require a Parsortix-based companion diagnostic to support regulatory approval."

The research, published as a peer-reviewed publication in the journal Frontiers in Oncology, is available online at https://angleplc.com/resources/publications/.

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Notes for editors

About ANGLE plc

ANGLE is a world-leading liquid biopsy company with innovative circulating tumour cell (CTC) solutions for use in research, drug development and clinical oncology using a simple blood sample. ANGLE's FDA cleared and patent protected CTC harvesting technology known as the Parsortix^® PC1 System enables complete downstream analysis of the sample including whole cell imaging and proteomic analysis and full genomic and transcriptomic molecular analysis.

ANGLE's commercial businesses are focusing on clinical services and diagnostic products. The clinical services business is offered through ANGLE's GCLP-compliant laboratories. Services include custom made assay development and clinical trial testing for pharma. Products include the Parsortix system, associated consumables and assays.

Over 100 peer-reviewed publications have demonstrated the performance of the Parsortix system. For more information, visit www.angleplc.com

Any reference to regulatory authorisations such as FDA clearance, CE marking or UK MHRA registration shall be read in conjunction with the full intended use of the product:

The Parsortix^® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood collected in K₂EDTA tubes from patients diagnosed with metastatic breast cancer. The system employs a microfluidic chamber (a Parsortix cell separation cassette) to capture cells of a certain size and deformability from the population of cells present in blood. The cells retained in the cassette are harvested by the Parsortix PC1 system for use in subsequent downstream assays. The end user is responsible for the validation of any downstream assay. The standalone device, as indicated, does not identify, enumerate or characterize CTCs and cannot be used to make any diagnostic/prognostic claims for CTCs, including monitoring indications or as an aid in any disease management and/or treatment decisions.

All results reported in this announcement and any other products and services are for research use only and not for use in diagnostic procedures.