Parsortix HER2 assay showcased at AACR 2024

CTC HER2 assay being developed for HER2 targeted drugs and antibody drug conjugates presented at internationally renowned AACR Annual Meeting 2024

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 its participation at the American Association for Cancer Research (AACR) Annual Meeting, San Diego, US between 5 to 10 April 2024.

ANGLE is presenting a poster entitled the "Development and analytical validation of a novel assay for HER2 assessment on circulating tumor cells harvested using the Parsortix® system and incorporating BioView imaging technologies". The poster pertains to the Company's collaboration with BioView, for which ANGLE is developing an end-to-end assay for the evaluation of human epidermal growth factor receptor 2 (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. The presented data showcases the development and analytical validation of this assay using the BioView Allegro Plus, an automated, high-throughput platform for imaging and identification of CTCs. The system facilitates the assessment of CTC classification, HER2 biomarker expression, and assessment of HER2 gene copy number by Fluorescence In Situ Hybridization.

ANGLE's in-house study reports the successful identification of the HER2 protein and gene copy information from cell targets with minimal cell loss. The analysis of clinical samples using the assay has demonstrated the ability to detect HER2 positive CTCs in patients who were previously HER2 negative based on a primary tissue biopsy. This assay is being developed as a product kit for minimally invasive identification of HER2 positive and HER2 low patients, who may benefit from HER2-targeted therapies and HER2 antibody-drug conjugates. The ability to monitor HER2 status over time from repeat blood samples may provide valuable data for assessing treatment options. The combination of ANGLE's Parsortix system for harvesting CTCs for analysis, BioView's imaging and analysis technologies, and the new HER2 CTC staining kit under development is intended to provide an easy to use assay based on a simple blood test, providing an up-to-date HER2 status for breast cancer patients on a repeat basis.

The evaluation of HER2 status via tissue biopsy is the current standard of care for guiding breast cancer patient treatment plans. However, tissue biopsy is invasive and difficult to repeat throughout the patient care pathway. Moreover, discordance between a primary tumour sample and a metastatic site is common. Liquid biopsy evaluation of HER2 status is a minimally invasive technique, suitable for repeat monitoring and capturing changes in disease status during and after treatment. Specifically, CTCs, as a liquid biopsy analyte have shown considerable potential to provide key information on HER2 status in breast cancer patients. One third-party study of 575 breast cancer patients found that HER2 status had changed in 38% of patients from the original primary tissue biopsy to the metastatic tissue biopsy, at disease recurrence1.

ANGLE Chief Scientific Officer, Karen Miller, commented:

"We are delighted to be presenting results from our HER2 assay development programme at the AACR's Annual Meeting as one of the key annual events in the cancer research calendar. We are excited to engage with the multidisciplinary community of attendees at this preeminent event to showcase this novel HER2 assay in partnership with BioView."

BioView Chief Scientific Officer, Chassidy Johnson commented:

"We are pleased to present both analytical and clinical data to support this novel HER2 assay being developed in collaboration with ANGLE. We believe this HER2 CTC assay has potential to greatly impact metastatic breast cancer patient care and look forward to this presentation at the 2024 AACR Annual Meeting."

About the AACR:

The AACR is the first and largest cancer research organisation dedicated to the prevention and cure of cancer. The AACR Annual Meeting is described as the focal point of the cancer research community, where cutting edge innovations in cancer science and medicine are presented from internationally renowned researchers and institutions. The annual conference is attended by scientists, clinicians, healthcare professionals, patient advocates and industry representatives, with last year's conference attracting over 21,000 attendees.

• Miglietta F et al. Evolution of HER2-low expression from primary to recurrent breast cancer. NPJ Breast Cancer. 2021 Oct 12;7(1):137

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