Avacta Group Regulatory News (AVCT)

2 November 2021

Avacta Group plc

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

Update on UK Availability of AffiDX SARS-CoV-2 Lateral Flow Rapid Antigen Test following Implementation of CTDA Regulations

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, notes that, as of 1 November 2021, the UK Health Security Agency's Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 ("CTDA regulations") have come into force. Consistent with these new regulations the Company has suspended, as of 1 November 2021, further sales of its AffiDX SARS-CoV-2 Lateral Flow Rapid Antigen Test in the UK until the ongoing desktop evaluation of the test has been successfully completed by the Agency and the test subsequently is put on the CTDA register for approved products. This is a new requirement for the supply of any COVID-19 test in the UK and is over and above the CE mark and successful registration of Company's AffiDX test with the MHRA which was announced on 7 June 2021.

The new CTDA Regulations stipulate that all suppliers of COVID-19 tests must submit information regarding their products for desktop review if they wish to remain on sale in the UK. As of 1 November 2021, there were only three products for which the Agency had completed its desktop review listed on the CTDA register for approved products. Additionally, the UK Health Security Agency has published a temporary protocol which lists 48 tests (both PCR and antigen based) which passed the Public Health England validation process at Porton Down earlier in the year that can remain available for sale in the UK whilst their validation is completed until a cut-off date of 28 February 2022.

Avacta submitted, ahead of the 1 September 2021 deadline, all the information required for its AffiDX test to be validated under these regulations by the UK Health Security Agency, and the Company has paid the required fee. The Company awaits further notification from the UK Health Security Agency when it completes its review of the information supplied for the AffiDX SARS-CoV-2 Lateral Flow Rapid Antigen Test.

The impact of suspension of sales in the UK as a result of the CTDA regulations coming into force will not have a material impact on the Company's anticipated financial outturn for the financial year ending 31 December 2021. As previously noted, Avacta continues to focus on opportunities outside of the UK for the sale and marketing of its AffiDX SARS-CoV-2 Lateral Flow Rapid Antigen Test including markets in Europe and further afield. 

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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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