Avacta Group Regulatory News (AVCT)

22 July 2020

Avacta Group plc

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

Update on Clinical Validation of Adeptrix COVID-19 Diagnostic Test

Avacta to begin clinical validation of the high throughput COVID-19 laboratory test in collaboration with the UK government CONDOR programme

Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has begun work with the UK government's CONDOR programme to evaluate and clinically validate the high throughput COVID-19 bead-assisted mass spectrometry ("BAMSTM") laboratory assay developed with Adeptrix (Beverly, MA, USA).

The COVID-19 National Diagnostic Research and Evaluation Platform (CONDOR), recently funded by the National Institute for Health Research, UK Research and Innovation, Asthma UK and the British Lung Foundation, was created by the UK government to provide a route for evaluating new COVID-19 diagnostic tests in hospitals and in community healthcare settings. 

Adeptrix's novel BAMS platform uses Affimer reagents to capture the virus and viral proteins from patient samples and combines this with the power of mass-spectrometry analysis to provide a highly sensitive and specific diagnostic test. Up to 1,000 nasopharyngeal swab or saliva samples per day can be analysed by a single technician using the BAMS assay, making it a very attractive high throughput technique for COVID-19 screening in the clinical setting.

Through the collaboration with the CONDOR scheme, Avacta will be provided access to patient samples and collaborators in UK hospitals to evaluate the performance of the prototype BAMS assay and to conduct the clinical validation study.

The work with the CONDOR programme will commence immediately to evaluate the test performance using real patient samples and will quickly progress to full clinical validation.

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

"I am delighted that the COVID-19 BAMS assay that we are developing with Adeptrix has been accepted into the CONDOR programme. This provides us with access to patient samples and partners in UK hospitals to rapidly carry out the validation studies that are critical to progress the BAMS assay development.

We are confident that the BAMS assay will perform very well and potentially provide a new gold standard for laboratory reference testing for the COVID-19 infection. The BAMS assay runs on equipment that is already installed in most hospital clinical microbiology labs but is currently unused for COVID-19 testing. Therefore, with the potential for a single technician to analyse up to 1,000 samples a day, the BAMS assay will provide a significant boost to centralised hospital testing capacity around the world.

I am also very pleased that the CONDOR programme will support the clinical validation of the rapid saliva-based COVID-19 antigen test strip that we are developing with Cytiva. This, combined with other collaborations that we are putting in place, will provide us with access to a sufficient number of COVID-19 patient samples to allow us to quickly clinically validate the saliva rapid test.

I look forward to providing further updates 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).

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

Avacta is developing novel cancer immunotherapies combining its two proprietary platforms - Affimer® biotherapeutics and pre|CISION™ tumour targeted chemotherapy. With this approach, the Company aims to address the lack of a durable response to current immunotherapies experienced by most patients. The Company's therapeutics development activities are based in Cambridge, UK.

The Company benefits from near-term revenues generated from Affimer reagents for diagnostics, bioprocessing and research, through a separate business unit based in Wetherby, UK.

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

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

By combining these two platforms the Company is building a wholly owned pipeline of novel cancer therapies with the aim of creating effective treatments for all cancer patients including those who do not respond to existing immunotherapies. Avacta expects to take its first drug, a pre|CISION targeted form of the standard-of-care Doxorubicin, into the clinic later in 2020 or early 2021.

Avacta has established drug development partnerships with pharma and biotech, including with Moderna Therapeutics Inc., a deal with LG Chem worth up to $310m, a partnership with ADC Therapeutics to develop Affimer drug conjugates and has established a joint venture in South Korea with Daewoong Pharmaceutical focused on cell and gene therapies incorporating Affimer immune-modulators. Avacta actively seeks to license its proprietary platforms in a range of therapeutic areas.

Avacta diagnostics business unit works with partners world-wide to develop Affimers for evaluation by those third parties with the objective of establishing royalty bearing license deals. The Company is also developing a small in-house pipeline of Affimer-based diagnostic assays for licensing.

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