Avacta Group Regulatory News (AVCT)

15 December 2021

Avacta Group plc

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

AffiDx® SARS-CoV-2 antigen lateral flow test detects the Omicron variant

Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms is pleased to announce that the AffiDX® antigen lateral flow test has been shown to detect the Omicron variant of the SARS-CoV-2 virus in clinical samples.

The Omicron (B.1.1.529) variant, with more than 35 mutations of the original SARS-CoV-2 virus, first appeared in South Africa a few weeks ago and was designated a variant of concern by the World Health Organisation (WHO) on 26 November 2021. The UK has now reported over 3,000 cases of this more infectious variant of the virus.

The AffiDX® SARS-CoV-2 antigen lateral flow test has been evaluated at the Carlos III Hospital in Madrid using a small number of actual patient samples confirmed to be Omicron variant positive. The results indicate that the AffiDX® antigen test detects the new Omicron variant in addition to all previously identified new variants of concern.

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

"We are delighted to confirm that the AffiDX® SARS-CoV-2 antigen lateral flow test detects the Omicron variant. As this variant is more infectious, it is important that it can be detected in individuals with higher loads using lateral flow tests so that its spread can be slowed down.

"We are progressing with our application to the CTDA in order to put the AffiDx product on the market in the UK, as well as continuing to pursue commercial opportunities in Europe and further afield for the professional-use test. We also continue to work with our partners, Medusa 19 Healthcare, to obtain the CE mark for consumer self-testing for the product which is a critical next step in the commercialisation of the product."

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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 London and 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 is developing an in-house pipeline of Affimer-based diagnostic assays, including the AffiDX® SARS-CoV-2 Lateral Flow Rapid Antigen Test, and works with partners world-wide to develop bespoke Affimer® reagents for third party products.

Avacta's Therapeutics Division is working to deliver a more tolerable and durable treatment response for oncology patients who do not respond to existing immunotherapies. By combining its two proprietary platforms the Group is building a wholly owned pipeline of clinically differentiated cancer therapies, aiming to extend the therapeutic benefits to all cancer patients. In 2021 Avacta transitioned to become a clinical stage biopharmaceutical company, commencing a phase I first-in-human, open label, dose-escalation and expansion study of AVA6000, a 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 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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