ANGLE plc ("the Company")

UPDATE ON ASTRAZENECA ASSAY DEVELOPMENT PROJECTS AND SUCCESSFUL COMPLETION OF EISAI CONTRACT

Development of both the prostate cancer androgen receptor assay and the multi-cancer DDR micronuclei assay successfully completed for AstraZeneca

Results of Eisai Phase 2 pilot study supports the capability of the Parsortix system for real-time assessment of breast cancer patient HER2 status and applicability of Parsortix-based HER2 assay for use in ADC clinical trials

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 delighted to announce that it has successfully completed the AstraZeneca development work for both the Parsortix-based Androgen Receptor ("AR") assay and the DNA damage response ("DDR") assay for the detection of micronuclei in CTCs as a measure of DNA damage. ANGLE has also successfully completed its contract with the global pharmaceutical company, Eisai Inc. ("Eisai") demonstrating the ability to measure HER2 CTC status dynamically over time. 

Update on AstraZeneca assay development projects

Both the developed assays (AR and DDR) have been approved for use by AstraZeneca and we are currently using the assays to test blood samples from patients. These developments put ANGLE in the position to be able to execute large scale clinical trials for AstraZeneca. In addition, ANGLE is working to progress discussions in other areas where we believe AstraZeneca could benefit from adopting CTC analysis.

ANGLE will now add the AR and DDR micronuclei assays to its menu of validated tests, which are available to pharma customers as a service from our clinical laboratory. Both the AR and DDR markets are considerable and growing, presenting an excellent opportunity for further pharma services contracts:

·    The AR therapeutic market is estimated to reach US$9.2 billion in 2033, driven by the rising prevalence of prostate cancer, the growing adoption of targeted therapies, and the increasing demand for personalised medicine. There are over 46,000 patients in 181 AR clinical studies, with ANGLE targeting key players in the space.

·    The DDR therapeutic market was estimated at US$8.2 billion in 2024 and is forecast to grow to US$30.3 billion over the next decade. The complex mechanisms involved in DNA repair and the potential for off-target effects necessitate rigorous preclinical and clinical evaluations. As such, real-time assessment of how the drug impacts the DDR pathway is particularly important during clinical trials and is only made possible through liquid biopsy. There are over 16,000 patients in 133 DDR clinical trials, again presenting a significant opportunity for ANGLE, with the addition of the DDR micronuclei assay complementing its γH2AX and pKAP1 DDR assays.

Results of Eisai Phase 2 pilot study

ANGLE provided CTC analysis with its Parsortix-based HER2 assay to assess breast cancer patients' HER2 (human epidermal growth factor receptor 2) status in a Phase 2 study of the HER2 targeting antibody-drug conjugate (HER2-ADC) BB-1701. Detailed analysis of the results demonstrates that:

·    patient samples were successfully processed with consistent results from two samples from each patient at each timepoint;

·    significant differences in HER2 CTC status and numbers of CTCs and CTC clusters were observed between the results for two different timepoints for the same patient before and after treatment.

This data is highly significant as it validates that ANGLE's HER2 assay is capable of measuring changes in HER2 status over time, which is not possible with a tissue biopsy as it is an invasive procedure which cannot always be repeated. This information is key to utilising the assay in clinical studies to assess patient treatment response and offers the potential to identify patients likely to respond to HER2-ADCs. 

The HER2 therapeutic market is a significant and growing sector, with a reported value of US$9.4 billion in 2023, projected to reach US$13.2 billion by 2030. The market is being driven by increasing usage of advanced and targeted therapeutic options such as monoclonal antibodies and antibody-drug conjugates (ADCs). Last year saw a record 481 new ADC trials announced, with HER2 listed as the leading target candidate, thus highlighting the opportunity for ANGLE's HER2 assay to support drug trials.

The full Phase 2 study of BB-1701 has not yet completed, and the drug efficacy results are unknown.  However, Eisai have made the strategic decision not to progress their option to BB-1701 further and have returned product development rights to BlissBio. ANGLE has nevertheless developed a very good working relationship with Eisai, who have indicated that there are other projects where Parsortix-based CTC analysis may be relevant, and we hope to progress these over time.

In addition, BlissBio, have confirmed their intention to progress BB-1701 themselves.  Accordingly, ANGLE is now seeking to engage with BlissBio in order to work with them on the next stage of development of BB-1701 although at this stage we have no specifics on this.

ANGLE Chief Executive Officer, Andrew Newland, commented:

"Successful completion of the AstraZeneca assay development projects is a key milestone for the Company in progressing our aim for Parsortix-based CTC analysis to be widely adopted for new and existing drugs to identify the right drug for the right patient at the right time. There is a clear business case for AstraZeneca and other large pharma to expand their markets for existing drugs by identifying patients expressing the target biomarker on CTCs, as biomarker status can change over time and impact response to treatment.

With regards to Eisai, we are delighted with the results of the HER2 CTC analysis, in both its reproducibility and its ability to dynamically measure HER2 changes over time, which we believe makes it ideally suited for HER2 and HER2-ADC clinical trials. There is considerable evidence, including ANGLE's in-house studies, that demonstrate that HER2 status of patients can change over time, with HER2 positive CTCs being found in patients who were initially HER2 negative based on their tissue biopsy.

Independent studies have shown that patients with HER2 positive CTCs can benefit from treatment with HER2 targeted treatment. This could open larger markets for HER2 drugs and improve outcomes for patients who would not otherwise receive HER2 treatment."

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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.