ANGLE plc ("the Company")

RESULTS FROM WORK TO DEVELOP A PARSORTIX-BASED Her2 assay KIT SHOWCASED AT INTERNATIONAL LIQUID BIOPSY CONFERENCE

Parsortix-based HER2 kit being developed to provide an optimised, easily implemented, solution to enable product customers to undertake longitudinal, repeat assessment of HER2 status in breast cancer

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 new data at the American Association for Cancer Research (AACR) Special Conference in Cancer Research in San Diego, US from 13 to 16 November 2024.

ANGLE is presenting a poster entitled the "Development of a scoring system to classify HER2 protein expression in Circulating Tumor Cells through immunofluorescence following isolation using Parsortix^® instruments" and reports on progress of the Company's co-development programme with BioView.

Using the high throughput BioView Allegro Plus microscope, ANGLE and BioView are developing an end-to-end assay kit for the evaluation of HER2 gene amplification and protein expression in circulating tumour cells (CTCs) harvested using the Parsortix system from the blood of metastatic breast cancer (MBC) patients.

Results presented showcase the development of a scoring system for HER2 expression, which could be implemented alongside the current standard of care which uses tumour tissue for HER2 assessment. The workflow was assessed in a cohort of 43 MBC patients. The study identified cases where HER2 status had changed over time and patients who were initially HER2 negative had, in the time elapsed since tissue biopsy, become HER2 positive based on their CTC analysis. 

Approximately 80% of breast cancer patients are categorised as HER2 negative based on tissue biopsy at diagnosis. However, it is well documented that HER2 status can change over time and a blood-based test could therefore enable the identification of patients who were previously HER2 negative who may now be HER2-low or positive and could therefore benefit from treatment with a HER2-targeted antibody drug conjugate (ADC) or anti-HER2 therapy.

BioView's Chief Scientific Officer, Chassidy Johnson, commented:

"The results ANGLE will present from our co-development work at the AACR Special Conference in Cancer Research are an important milestone in our development programme. The results highlight the ability and robust analytical performance of the developed HER2 CTC assay to detect ranges of HER2 expression therefore potentially identifying patients that could benefit from anti-HER2 therapy as well as newer HER2-targeted ADCs."

ANGLE's Chief Scientific Officer, Karen Miller, commented:

"We are pleased to present new data from our collaborative HER2 assay development programme at the AACR Special Conference in Cancer Research. This study highlights the potential for longitudinal, repeat assessment of HER2 CTC status to identify patients whose HER2 status has changed and could therefore benefit from treatment with HER2-targeted ADC or anti-HER2 therapy."

The poster is available for review at: https://angleplc.com/resources/posters/.

For further information:

For Research Use Only. Not for use in diagnostic procedures.

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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.