Avacta Group Regulatory News (AVCT)

04 August 2021

Avacta Group plc

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

Update on AffiDX® SARS-CoV-2 Antigen Lateral Flow Test

Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer® and pre|CISION™ platforms is pleased to announce that shipment of its AffiDX® SARS-CoV-2 antigen lateral flow test has now commenced.

The AffiDX® SARS-CoV-2 antigen lateral flow test is a high performance, 20-minute antigen test using patient-friendly nasal swabbing that is CE marked for professional use in the UK and EU. The test has been shown by independent clinical evaluation to be 100% sensitive for patient samples with a PCR Ct value below 27 (high viral load), 98.0% sensitive across a much wider range of viral loads and with 99% specificity. The test has also been shown to detect all the major variants of the virus including the delta variant.

The Company has recently appointed Calibre Scientific, a global distributor of diagnostic and life science products, as the first distributor for the test in the UK and European Union, and is progressing multiple commercial opportunities with distributors and end users in Europe, UK, Asia and elsewhere.

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

"I am delighted that shipment of the AffiDX® SARS-CoV-2 antigen lateral flow test has commenced. The excellent clinical performance and ease of nasal sampling, coupled with the fact that the AffiDX® antigen test has been developed in the UK, and is based on UK technology and manufactured in the UK, are major points of differentiation.

"Manufacturing scale up continues to progress well and we remain focused on the challenge of being able to supply the clear demand in the market.

"We continue to see significant levels of commercial interest from around the world and are progressing a number of opportunities in a range of sectors. I look forward to updating the market on further developments."

-Ends-

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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|CISIONTM 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 Group is also developing an in-house pipeline of Affimer-based diagnostic assays including the AffiDX® SARS-CoV-2 Lateral Flow Rapid Antigen Test and AffiDX® BAMS™ 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 Group is building a wholly owned pipeline of novel cancer therapies deigned to be effective for all cancer patients. In 2021 Avacta a clinical stage biopharmaceutical company, commencing a phase 1 first-in-human, open label, dose-escalation and expansion study of AVA6000 Pro-doxorubicin, the Group's lead pre|CISION™ 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 ModernaTX,Inc. (formerly 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|CISION™ platform. Avacta continues to actively seek to license its proprietary platforms in a range of therapeutic areas.

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