Angle PLC Announces Partnership with Major United States Urology Group & More News Here

PARTNERSHIP ESTABLISHED WITH A MAJOR UNITED STATES UROLOGY GROUP TO CONDUCT CLINICAL STUDIES IN PROSTATE CANCER AND AS A POTENTIAL ROUTE TO MARKET

MidLantic Urology to guage the Parsortix system in prostate most cancers medical research and allow potential gross sales to Solaris Health in depth affected person base

Major unmet medical want for a pre-screening instrument forward of invasive prostate tissue biopsy as an support to assessing prostate most cancers presence and aggressiveness to information therapy decisions

GUILDFORD, UK / ACCESSWIRE / May 30, 2022 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy firm, is delighted to announce it has signed a grasp medical examine settlement with Solaris Health Holdings, LLC (Solaris) and joinder agreements with MidLantic Urology LLC, to collaborate and conduct medical research in prostate most cancers and as a possible path to market within the United States.

MidLantic Urology, an affiliate of Solaris, is without doubt one of the largest suppliers of specialist urology providers within the United States with greater than 70 physicians working from 47 devoted urology centres throughout the state of Pennsylvania. The Solaris Health community encompasses greater than 500 medical urology suppliers throughout 179 areas and 9 States with greater than 729,000 distinctive sufferers yearly.

Together with MidLantic Urology, ANGLE will provoke medical research geared toward investigating the usage of the Parsortix^® system for the detection of prostate most cancers and prediction of its severity in sufferers who current with an elevated prostate particular antigen (PSA) stage and/or irregular digital rectal examination.

The design of the primary examine to be carried out with MidLantic Urology, anticipated to be initiated in Q3 2022, has been knowledgeable by earlier pilot research independently carried out on the Barts Cancer Institute (Queen Mary University London) which used the Parsortix system to reap circulating tumour cells (CTCs). This examine will initially enrol 100 males scheduled to endure a prostate tissue biopsy at a minimal of three examine websites over an anticipated interval of as much as 9 months. Blood samples collected by MidLantic Urology will likely be shipped to ANGLE’s United States medical laboratory for processing by the Parsortix system to reap and analyse CTCs and related immune cells. The Parsortix harvests will likely be evaluated by each imaging and molecular evaluation to evaluate the potential to foretell the presence of clinically vital prostate most cancers previous to tissue biopsy and to evaluate potential correlation with established illness severity scores (e.g. the Gleason rating) in these sufferers discovered to have prostate most cancers.

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ANGLE expects headline outcomes from the primary examine of 100 males in 2023. Compelling information may kind the idea of a laboratory developed check which ANGLE would supply from its medical laboratories within the United States and the UK. Solaris may very well be ANGLE’s first path to marketplace for this check, providing the established check to their in depth affected person base. Successful outcomes may additionally permit the design of a bigger validation examine to help an eventual submission to FDA and different regulatory our bodies for this utility.

Prostate most cancers is the main reason behind most cancers in males and accounts for 13% of all new most cancers circumstances within the United States. Under the nationwide screening programme, 11 million males will endure a PSA check within the US every year. Of these, some 1.2 million could have an irregular end result, resulting in additional investigations. The present commonplace of care, transrectal or transperitoneal prostate tissue biopsy, is an invasive process related with vital medical problems and value. Following the process, 32% of sufferers are reported to expertise average negative effects, with 1.4% of sufferers experiencing main problems. This consists of post-biopsy sepsis in 2-5% of circumstances with as much as 25% requiring admission to ICU at an estimated price of US$19,000 per affected person. Prostate tissue biopsies are adverse in 75% of sufferers and due to this fact place sufferers at pointless danger however may additionally miss the most cancers in 30-40% of circumstances, requiring sufferers to endure repeat tissue biopsy. At least 60% of prostate cancers recognized are indolent and unlikely to trigger hurt throughout a affected person’s lifetime. Nonetheless many males will endure radical prostatectomy which is related with vital post-procedure problems together with urinary incontinence and erectile dysfunction. Liquid biopsy presents the potential for a a lot safer, cost-effective prognosis, energetic surveillance the place acceptable and, following prognosis, the flexibility to supply longitudinal monitoring and updated focused therapy choice.

Dr Jose Moreno, Principal Investigator, MidLantic Urology, commented:

“Even though PSA is a valuable marker of response to prostate cancer treatment, its role in screening is modest at best and can lead to both overdiagnosis of clinically indolent prostate cancer and underdiagnosis of clinically significant prostate cancer which can result in increased rates of local failure and metastatic disease.

ANGLE’s Parsortix platform has the potential to enable molecular characterisation of the cancer using a blood test in patients undergoing both traditional ultrasound biopsies and MRI fusion biopsies. The preliminary data suggest that we may be able to create an assay for the detection of clinically significant prostate cancer that has high specificity and sensitivity. Moreover, the assay can be customized to operate in a wide spectrum of prostate cancer disease states, including pre-prostate biopsy, after a negative biopsy, active surveillance, after local failure, and in early and late metastatic disease states. If our results are validated, our MidLantic Urology patients and Solaris Health affiliates may be the first to benefit from these developments.”

ANGLE Founder and Chief Executive, Andrew Newland, added:

“We are delighted that Solaris and MidLantic Urology have agreed to work with ANGLE on clinical studies in prostate cancer, which build on prior work done by Barts Cancer Institute and demonstrates the power of our leveraged research approach. Successful development of this simple blood test could prevent men from being subjected to unnecessary tissue biopsies when they either do not have prostate cancer (despite the elevated level of PSA) or their cancer is indolent and unlikely to impact either their life expectancy or quality of life.

The funding for this study, which addresses a major unmet medical need, was a key element of our capital raise last year and could open up a significant market opportunity for ANGLE. Initiation of the study, expected in the near future, delivers on another business milestone as we build out our commercial plans for the Parsortix system.”

For additional data:

The data contained inside this announcement is deemed by the Company to represent inside data as stipulated below the EU Market Abuse Regulation (596/2014). Upon the publication of this announcement by way of a regulatory data service, this data is taken into account to be within the public area.

For Frequently Used Terms, please see the Company’s web site on https://angleplc.com/investor-relations/glossary/

Notes for editors

About ANGLE plcwww.angleplc.com

ANGLE is a world main liquid biopsy firm with sample-to-answer options. ANGLE’s confirmed patent protected platforms embrace a circulating tumor cell (CTC) harvesting expertise generally known as the Parsortix^® system and a downstream evaluation system for price efficient, extremely multiplexed evaluation of nucleic acids and proteins.

ANGLE’s Parsortix^® system is FDA cleared for its meant use in metastatic breast most cancers and is at present the primary and solely FDA cleared medical system to reap intact circulating most cancers cells from blood.

Intended use

The Parsortix^® PC1 system is an in vitro diagnostic system meant to counterpoint circulating tumor cells (CTCs) from peripheral blood collected in Ok₂EDTA tubes from sufferers recognized with metastatic breast most cancers. The system employs a microfluidic chamber (a Parsortix cell separation cassette) to seize cells of a sure measurement and deformability from the inhabitants of cells current in blood. The cells retained within the cassette are harvested by the Parsortix PC1 system to be used in subsequent downstream assays. The finish person is liable for the validation of any downstream assay. The standalone system, as indicated, doesn’t determine, enumerate or characterize CTCs and can’t be used to make any diagnostic/prognostic claims for CTCs, together with monitoring indications or as an support in any illness administration and/or therapy choices.

The Parsortix system allows a liquid biopsy (a easy blood check) for use to supply the circulating metastatic breast most cancers cells to the person in a format appropriate for a number of kinds of downstream analyses. The system is predicated on a microfluidic system that captures cells based mostly on a mixture of their measurement and compressibility. The system is epitope impartial and might seize all phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) in addition to CTC clusters in a viable kind (alive). CTCs harvested from the system allow an entire image of a most cancers to be seen; as being an intact cell they permit DNA, RNA and protein evaluation in addition to cytological and morphological examination and should present comparable evaluation to a tissue biopsy in metastatic breast most cancers. Because CTC evaluation is a non-invasive course of, not like tissue biopsy, it may be repeated as typically as wanted. This is essential as a result of most cancers develops and adjustments over time and there’s a clear medical want for up-to-date data on the standing of a affected person’s tumor. In addition, the dwell CTCs harvested by the Parsortix system will be cultured, which presents the potential for testing tumor response to medicine outdoors the affected person.

The Parsortix expertise is the topic of 26 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three in depth households of patents are being progressed worldwide.

In the United States, the Parsortix^® PC1 system has acquired a Class II Classification from FDA to be used with metastatic breast most cancers sufferers. FDA clearance is seen as the worldwide gold commonplace. ANGLE’s Parsortix system is the primary ever FDA cleared system for harvesting CTCs for subsequent evaluation. ANGLE has utilized the IVD CE Mark to the identical system for a similar meant use in Europe.

ANGLE has additionally accomplished two separate 200 topic medical research below a program designed to develop an ovarian most cancers pelvic mass triage check, with the outcomes displaying greatest at school accuracy (AUC-ROC) of 95.1%. The pelvic mass triage assay has undergone additional refinement and optimisation and a 200 affected person medical verification examine has now accomplished enrolment.

ANGLE’s expertise for the multiplex analysis of proteins and nucleic acids of all kinds is named the HyCEAD^TM platform and is predicated on a patented movement via array expertise. It gives for low price, extremely multiplexed, speedy and delicate seize of targets from all kinds of pattern sorts. A proprietary chemistry method (the HyCEAD methodology) permits for the seize and amplification of over 100 biomarkers concurrently in a single response. The HyCEAD system is extraordinarily delicate and is good for measuring gene expression and different markers immediately from Parsortix harvests and was used within the ovarian most cancers pelvic mass triage check to attain greatest at school accuracy (AUC-ROC) of 95.1%.

ANGLE’s proprietary applied sciences will be mixed to supply automated, sample-to-answer ends in each centralised laboratory and point-of-use cartridge codecs.

ANGLE has established formal collaborations with world-class most cancers centres and main corporates resembling Abbott, Philips and QIAGEN, and works carefully with main CTC translational analysis clients. These Key Opinion Leaders (KOLs) are working to determine functions with medical utility (clear profit to sufferers), and to safe medical information that demonstrates that utility in affected person research. The physique of proof as to the advantages of the Parsortix system is rising quickly from our personal medical research in metastatic breast most cancers and ovarian most cancers and in addition from KOLs with 60 peer-reviewed publications and quite a few publicly obtainable posters from 31 impartial most cancers centres, obtainable on our web site.

ANGLE has established medical providers laboratories within the UK and the United States to speed up commercialisation of the Parsortix system and act as demonstrators to help product growth. The laboratories supply providers globally to pharmaceutical and biotech clients to be used of Parsortix in most cancers drug trials and, as soon as the laboratories are accredited and assessments validated, will present Laboratory Developed Tests (LDTs) for affected person administration.

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SOURCE: ANGLE plc

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