Angle Regulatory News (AGL)

ANGLE plc

("ANGLE" or "the Company")

Parsortix Update

PARSORTIX GEN2 SEPARATION CASSETTE - DESIGN BREAKTHROUGH

ANGLE plc (AIM: AGL), the technology commercialisation company, is delighted to announce that it has successfully achieved crucial new capabilities in the performance of its Parsortix cancer cell separation device.

ANGLE has previously demonstrated that its Parsortix separation technology can capture cultured breast cancer, prostate cancer, lung cancer, colon cancer and ovarian cancer cells added to blood (spiked blood) and has successfully captured circulating tumour cells (CTCs) in prostate cancer and breast cancer patient blood.

Capture of the very rare CTCs in cancer patient blood may enable the development of a simple blood test to allow the:

·; prognostic assessment of patients to predict the likely outcome of their cancer enabling a more informed consideration of their treatment options at the outset;

·; monitoring of cancer patients during treatment to assess their progress and determine which treatments are likely to be effective for them;

·; post-treatment monitoring of patients in remission for early detection of potential relapse, with the potential to improve treatment success rates for secondary cancers.

Primarily as a result of the original design being for the separation of foetal cells from peripheral maternal blood for foetal health diagnostics, the first generation of Parsortix separation technology (known as Parsortix GEN1) was limited to a blood sample volume of circa 1ml and a flow rate of circa 0.1ml/hour. Efficacy and practicality in clinical CTC applications requires separations of 7.5ml blood volumes in times of a few hours.

Because of this, ANGLE has previously advised the market of a critical and challenging objective to develop "new separation device designs to allow ease of use in the laboratory addressing critical factors of increasing the volume of blood that can be screened and the speed of blood flow through the device". A related and important issue was that GEN1 captured not only the target cancer cells but also the patient's white blood cells (albeit in a different location within the cassette), which are not cells of interest in the cancer application.

Successfully redesigning the cassette to address these key issues has been considered a major technology risk remaining with the Parsortix development and has required a major engineering development effort over the last six months.

Highly innovative design and manufacturing by the Parsortix technical team and its partners has generated an advanced new form of the cassette (GEN2). Externally GEN2 maintains the same simple design and size, but internally the patented step arrangement has an entirely new structure and layout.

Experimentation using the GEN2 cassettes has demonstrated a tremendous improvement in cassette performance, surpassing our most optimistic expectations.

The Parsortix GEN2 cassette has successfully allowed:

·; Blood sample volumes of 8ml to be separated. It appears that substantially larger volumes of blood can be processed if required, although this has not yet been demonstrated.

·; A flow rate of 8ml/hour to be utilised without any fracture or damage to the target cancer cells. This meets the top end target that we set for the device. However it appears that we may be able to substantially increase flow rates beyond this level, although again this has not yet been demonstrated.

·; Near complete reduction in the debris and clogging to which the GEN1 cassette can be prone.

·; Visual identification of cultured cancer cells spiked in healthy whole blood with cancer cell capture and enumeration being accurate to approximately 10% of the cells added for numbers of cancer cells added of 0, 15, 200, and 2,000 cells in volumes of blood ranging from 1ml to 8ml. Bearing in mind that there is a level of statistical variation when adding the spiked cells into the blood, this is indicative of complete capture of the added cancer cells.

·; Formal identification of the added cancer cells using industry standard immuno-staining within the cassette for cytokeratin 18, an epithelial marker used to indicate cancer. Again there was very good enumeration of the cells, closely in line with the number of cells spiked in the blood.

·; Capture of the target cancer cells without capture of other non-target cells (other than very low levels of red blood cells and white blood cells on the periphery of the cassette) and without any build-up of aggregate or debris, making visualisation and identification of cancer cells even easier.

The most challenging separation so far completed was 15 cancer cells added to 8ml of whole blood, which equates to looking for one cancer cell in 2.8 billion other cells. Our complete success (subject to the tolerances of counting the cells) in visually identifying the target cells in this sample within one hour of receiving the sample is testament to the sensitivity of the new Parsortix GEN2 design.

We are greatly encouraged by the success of this further development of our technology. Our technical development is proceeding to plan and we are on track to meet the next key milestones, which are:

·; Validation of the separation device for other cancer types;

·; Independent third party validation of the performance of the Parsortix CTC separation device by leading cancer research centres including the Paterson Institute for Cancer Research; and

·; Development and launch of the Parsortix cancer diagnostic product for research purposes, with initial sales to cancer research centres and pharmaceutical companies developing cancer drugs.

Development of the Parsortix cancer diagnostic product for research purposes is in progress and is expected to involve a Parsortix GEN3 cassette as a consumable together with a compact and relatively inexpensive instrument on which to run the separation. This work is in progress and we hope that it will be complete in time for us to take delivery of the first units in Q3 this year. Sales for research purposes can then commence once the product has been tested both in-house and by our partners.

ANGLE's Founder and Chief Executive, Andrew Newland, commented:

"Solving the critical issues of sample volume and processing time is extremely important. This major breakthrough proves the potential for the Parsortix technology to address the market requirements and in doing so brings us much closer to market launch."

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