Avacta Group Regulatory News (AVCT)

14 July 2021

Avacta Group plc

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

Avacta's Diagnostic Division Achieves ISO 13485 Certification

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 Avacta Life Sciences' diagnostics division has achieved ISO 13485 certification for the quality management system for the manufacture and distribution of Affimer® reagents for use in lateral flow, ELISA and immunodiagnostic in-vitro diagnostic devices.

The ISO 13485 standard defines the comprehensive requirements for quality management for a developer and legal manufacturer of diagnostic products and medical devices. The certification, which provides a practical foundation for Avacta to address the regulatory requirements and ensure the safety and quality of its products, follows after having successfully passed the audit by the Avacta's Notified Body (BSI Group) of the Company's quality management system in April 2021.

ISO 13485 certification means that the CE mark for the AffiDX® SARS-CoV-2 antigen lateral flow test can be transferred to Avacta from its partner, Mologic, and Avacta will be legal manufacturer of all future in-vitro diagnostic products.

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

"We are delighted that Avacta's diagnostics division has achieved ISO 13485 certification. The team have delivered excellent systems, processes and practices that now make up our quality framework, supporting the future growth and commercial success of the company.

"ISO 13485 certification is recognised globally by our partners, customers and regulatory bodies alike as the medical device industry benchmark for quality. This certification marks a major milestone for Avacta and underpins the product development strategy for the future of our diagnostics division."

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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 will commence 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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