ANGLE plc ("the Company")

Pharma Services Contract with Crescendo Biologics

Crescendo to use ANGLE's recently launched Portrait Flex Assay in prostate cancer study

ANGLE plc (AIM: AGL; OTCQX: ANPCY), a world-leading liquid biopsy company, is delighted to announce that it has signed a contract with a new customer, Crescendo Biologics Limited ("Crescendo"). Crescendo is a UK-based, clinical stage immuno-oncology company with an extensive proprietary pipeline of novel, targeted T cell enhancing Humabody^® therapeutics. Crescendo will use ANGLE's recently launched Portrait Flex assay in its ongoing Phase 1 clinical trial (NCT04839991) investigating the safety and efficacy of CB307, Crescendo's first-in-class prostate-specific membrane antigen (PSMA) x CD137 half-life extended bispecific, for the treatment of patients with PSMA positive solid tumours.

ANGLE developed the immunofluorescence (IF) Portrait Flex assay for the detection of epithelial and mesenchymal circulating tumour cells (CTCs) as well as those undergoing the epithelial-mesenchymal transition (EMTing). Additionally, the assay offers the customer the possibility of adding any bespoke protein biomarker, depending on its needs. The assay has high sensitivity and specificity (>90%) for epithelial and mesenchymal CTCs, which are known to be involved in cancer metastasis and drug resistance and was launched in late 2022 as an offering to pharma services customers.

Crescendo will use the Portrait Flex assay in the cohort expansion part of its ongoing clinical study, sending patient samples to ANGLE's ISO15189 accredited clinical laboratories for processing using the Parsortix system and analysis.

Crescendo Biologics' VP, Translational Biology, Dr Andrew Pierce, commented:

"We are excited to be working with ANGLE to provide an important element of our robust translational package as we seek to further illustrate the mechanism by which CB307 can bring clinical benefit to patients."

ANGLE Founder and Chief Executive, Andrew Newland, added:

"The use of CTC biomarkers in clinical trials is a rapidly growing field, facilitating the identification of druggable targets as well as providing prognostic information, predicting treatment response, resistance, and patient relapse. We are delighted that Crescendo Biologics has adopted our new Portrait Flex assay and we will seek opportunities to expand our relationship going forward. Our menu of Parsortix based CTC assays is building and the pipeline of potential pharma services customers is growing as a result."

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Notes for editors

About Crescendo Biologics

Crescendo Biologics is a private, clinical stage immuno-oncology company developing novel, targeted T cell enhancing Humabody^® therapeutics.

Leading its proprietary pipeline, Crescendo Biologics has developed CB307, a novel half-life extended CD137 x PSMA Humabody for the selective activation of tumour-specific T cells exclusively within the tumour microenvironment. CB307 is designed to achieve a longer lasting anti-cancer effect whilst avoiding systemic toxicity, and the clinical programme for CB307 is underway in patients with PSMA positive solid tumours (NCT04839991). CB693 is a half-life extended CD137 x MSLN Humabody and is the second proprietary clinical candidate from Crescendo's T cell enhancing pipeline. Crescendo is also developing CB213, a preclinical PD-1 x LAG-3 multi-specific Humabody.

The Company's ability to develop multi-functional Humabody therapeutics is based on its unique, patent protected, transgenic mouse platform generating fully human VH domain building blocks (Humabody VH). These robust molecules can be configured to engage therapeutic targets in such a way that they deliver novel pharmacology and superior bio-distribution. This can lead to larger therapeutic windows compared to conventional IgG approaches. Humabody-based formats can also be applied across a range of non-cancer indications.

Beyond Crescendo's proprietary pipeline, the Company has global, multi-target discovery and development collaborations with both Takeda and BioNTech and an exclusive, worldwide licensing agreement with Zai Lab for ZL-1102 (formerly CB001, an anti-IL-17A targeting Humabody), which is expected to enter global Phase 2 clinical development in patients with psoriasis.

Crescendo Biologics is located in Cambridge, UK, and is backed by blue-chip investors including Sofinnova Partners, Andera Partners, IP Group, BioNTech, Takeda and Quan Capital.

For more information, please visit www.crescendobiologics.com and follow @HUMABODY.

About ANGLE plc www.angleplc.com 

ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected circulating tumor cell (CTC) harvesting technology is known as the Parsortix^® system.

ANGLE's Parsortix^® system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood.

Intended use

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.

The Parsortix system enables a liquid biopsy (a simple blood test) to be used to provide the circulating metastatic breast cancer cells 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 phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) as well as CTC clusters in a viable form (alive).  CTCs harvested from the system enable a complete picture of a cancer to be seen; as being an intact cell they allow DNA, RNA and protein analysis as well as cytological and morphological examination and may provide comparable analysis to a tissue biopsy in metastatic breast cancer. 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 of a patient's tumor. In addition, the live CTCs harvested by the Parsortix system can be cultured, which offers the potential for testing tumor 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 are being progressed worldwide.

In the United States, the Parsortix^® PC1 system has received a Class II Classification from FDA for use with metastatic breast cancer patients. FDA clearance is seen as the global gold standard. ANGLE's Parsortix system is the first ever FDA cleared system for harvesting CTCs for subsequent analysis. ANGLE has applied the IVD CE Mark to the same system for the same intended use in Europe.

ANGLE has also completed three 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 95.4% with sensitivity of 90% and specificity of 93%. This excellent clinical result demonstrates the utility of cells harvested by the Parsortix system, which the Company believes is the "best sample" for liquid biopsy analysis as it recovers intact, living cancer cells that are involved in the progression of the disease providing prospective information.

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 77 peer-reviewed publications and numerous publicly available posters from 35 independent cancer centres, available on our website.

ANGLE has established clinical services laboratories in the UK and the United States to accelerate commercialisation of the Parsortix system and act as demonstrators to support product development. The laboratories offer services globally to pharmaceutical and biotech customers for use of Parsortix in cancer drug trials and, once the laboratories are accredited and tests validated, will provide Laboratory Developed Tests (LDTs) for patient management.