Avacta Group Regulatory News (AVCT)

16 February 2021

Avacta Group plc

("Avacta" or "the Group" or "the Company")

Results of Initial Evaluation of SARS-CoV-2 Lateral Flow Antigen Test with Clinical Samples

Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, announces that it has received the first data for its SARS-CoV-2 rapid antigen test from ongoing clinical studies in Europe and the UK. These data show excellent performance of the test in identifying patients with an infectious viral load and no false positive results.

Avacta's SARS-CoV-2 rapid antigen test has been developed to identify infectious individuals so that they can isolate promptly and reduce the spread of COVID-19. A recent report from the Liverpool Covid SMART Pilot Study1 indicates that individuals with COVID-19 infection had a significant chance of infecting their contacts if they had a viral load measured by PCR, called the Ct value (cycle threshold value), of approximately 25 or lower. The Ct value indicates how many PCR cycles are required to amplify the viral RNA so that it can be detected and a lower Ct value indicates a higher viral load.

The initial evaluation of Avacta's lateral flow rapid antigen test with clinical samples has been carried out at two sites, one in EU and one in the UK using patient samples with viral loads confirmed by PCR. 30 positive samples were tested with Ct values of 26 and below, with half of those in the range 22-26, and the lateral flow test identified 29/30 of these correctly as positive. This indicates a clinical sensitivity of 96.7% for samples with a Ct value below 26. Importantly, out of a total of 26 negative samples tested with the lateral flow device, the test correctly identified all 26 as negative, giving a clinical specificity of 100%. High specificity is critical for a lateral flow test for mass screening so that large numbers of false positives are not generated which would create a major burden on follow-on testing resources, and result in a significant socio-economic cost of unnecessarily isolating people.

On the basis of these excellent initial data, the Company will now progress to a full clinical validation with a larger number of patient samples to CE mark the test for professional use, aiming to bring the test to market in Europe around the end of the first quarter of this year.

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: 

"I am delighted with the performance of the test with clinical samples which is extremely encouraging.

On the basis of these initial clinical studies, the lateral flow test shows very good sensitivity in the infectious range of viral loads including at the lower infectious loads with Ct values of 23-26 which compares very favourably with the data reported in the Liverpool Covid SMART Pilot Study report.

These data from the first clinical studies will allow us to quickly progress with confidence into the full clinical validation of the test, manufactured at scale, at our clinical trial sites in the UK and the EU. I am confident that these data will accelerate our commercial discussions regarding the roll-out of the test when it is approved for professional use.

I look forward to updating the market on clinical and commercial progress in due course."

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

Disclaimer: The AffiDxTM SARS-Cov-2 rapid antigen test is not currently available for sale in the United States.

- Ends-

1 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/950695/s0958-liverpool-covid-smart-evaluation.pdf

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About Avacta Group plc - https://www.avacta.com

Avacta Group is developing novel cancer immunotherapies and powerful diagnostics based on its two proprietary platforms - Affimer® biologics and pre|CISION™ tumour targeted chemotherapies.

The Affimer platform is an alternative to antibodies derived from a small human protein. Despite their shortcomings, antibodies currently dominate markets, such as diagnostics and therapeutics, worth in excess of $100bn. Affimer technology has been designed to address many of these negative performance issues, principally: the time taken to generate new antibodies and the reliance on an animal's immune response; poor specificity in many cases; their large size, complexity and high cost of manufacture.

Avacta's pre|CISION targeted chemotherapy platform releases active chemotherapy in the tumour, which limits the systemic exposure that causes damage to healthy tissues, and thereby improves the overall safety and therapeutic potential of these powerful anti-cancer treatments.

The Group comprises two divisions: The therapeutics development activities are based in Cambridge, UK and the Group is generating near-term revenues from Affimer reagents for diagnostics, bioprocessing and research, through a separate diagnostics business unit based in Wetherby, UK.

Avacta's Diagnostics Division works with partners world-wide to develop bespoke Affimer reagents for third party products. The Company is also developing an in-house pipeline of Affimer-based diagnostic assays including the AffiDXTM SARS-CoV-2 Lateral Flow Rapid Antigen Test and a BAMSTM SARS-CoV-2 Assay in partnership with Adeptrix Inc.

Avacta's Therapeutics Division is addressing a critical gap in current cancer treatment - the lack of a durable response to current immunotherapies experienced by most patients. By combining its two proprietary platforms the Company is building a wholly owned pipeline of novel cancer therapies deigned to be effective for all cancer patients. In 2021 Avacta will commence a phase 1 first-in-human, open label, dose-escalation and expansion study of AVA6000 Pro-doxorubicin, the Company's lead pre|CISIONTM prodrug, in patients with locally advanced or metastatic selected solid tumours.

Avacta has established drug development partnerships with pharma and biotech, including a research collaboration with Moderna Therapeutics Inc., a multi-target deal with LG Chem worth up to $400m, a joint venture in South Korea with Daewoong Pharmaceutical focused on cell and gene therapies incorporating Affimer immune-modulators, a partnership with ADC Therapeutics to develop Affimer-drug conjugates and a collaboration with Point Biopharma to develop radiopharmaceuticals based on the pre|CISIONTM platform. Avacta actively seeks to license its proprietary platforms in a range of therapeutic areas.

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