Update on Lateral Flow Test Regulatory Submissions
1 June 2021
Avacta Group plc
("Avacta" or "the Group" or "the Company")
Update on SARS-CoV-2 Antigen Lateral Flow Test Regulatory Submissions
Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer® and pre|CISION™ platforms, today releases an update on the submission of the Declaration of Conformity for CE mark of its AffiDX® SARS-CoV-2 antigen lateral flow test for professional use. As previously announced, this regulatory submission was the responsibility of the Group's partner, Mologic Limited ("Mologic"), a leading developer of lateral flow and rapid diagnostic technologies, products and services.
On 10 May, Avacta announced that Mologic had submitted the Declaration of Conformity to the Medicines and Healthcare products Regulatory Agency ("MHRA") in the UK at that date. The regulatory submissions to both the MHRA and to a Competent Authority in a European Union member state were sub-contracted by Mologic to an independent regulatory consulting agency. An error made by that agency, for which it was solely responsible, resulted in a delay to the MHRA submission which was finally made on 28 May. In the meantime, the Company has continued its discussions with distributors and customers for the AffiDX® antigen test and does not anticipate that the error will cause a delay to first commercial sales of the product.
Following the delayed MHRA submission, it is anticipated that Mologic will receive confirmation of registration of the AffiDX® test for the UK market from the MHRA shortly. The Company can confirm that the submission of the Declaration of Conformity has also been made to a Competent Authority in a European Union member state to enable marketing and sale of the AffiDX® SARS-CoV-2 antigen lateral flow test in the EU.
Avacta can also confirm that the SARS-CoV-2 test referenced in a social media post on 27 May, highlighting an email that had been obtained from the MHRA reporting rejection of a filing of a Declaration of Conformity of a SARS-CoV-2 antigen test from Mologic, was an unrelated Mologic antigen test. It was not the Avacta AffiDX® SARS-CoV-2 antigen lateral flow test as purported in the social media post.
The Company looks forward to updating the market shortly on the responses from the Competent Authorities in the UK and EU and on commercial progress for its AffiDX® SARS-CoV-2 antigen lateral flow test.
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For further information from Avacta Group plc, please contact:
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Avacta Group plc Alastair Smith, Chief Executive Officer Tony Gardiner, Chief Financial Officer Michael Vinegrad, Group Communications Director |
Tel: +44 (0) 844 414 0452
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Stifel Nicolaus Europe Limited (Nomad and Broker) |
Tel: +44 (0) 207 710 7600 |
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Nicholas Moore / Nick Adams / Fred Walsh / Ben Maddison |
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FTI Consulting (Financial Media and IR)
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Tel: +44(0) 203 727 1000
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Zyme Communications (Trade and Regional Media) Katie Odgaard
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Tel: +44 (0)7787 502 947 katie.odgaard@zymecommunications.com
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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 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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