Avacta Group Regulatory News (AVCT)

2 September 2020

Avacta Expands Rapid SARS-CoV-2 Antigen Test Manufacturing Capacity

Manufacturing agreement with Abingdon Health for Avacta's rapid COVID-19 saliva test

Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has entered into an agreement with Abingdon Health for the manufacture of Avacta's saliva-based rapid SARS-CoV-2 antigen test as part of its ongoing expansion of manufacturing capacity.

Avacta, in partnership with Cytiva, is developing a rapid test strip for use with patient saliva that aims to provide a result in a few minutes, indicating whether the patient is currently infected with the SARS-CoV-2 coronavirus. The test has the potential to be used for frequent mass testing of the population to promptly identify infectious individuals so that they can be isolated and treated, thereby reducing the spread of infection.

Avacta recently announced a manufacturing partnership with BBI Solutions to develop and validate a scaled-up manufacturing process for the rapid coronavirus antigen test. Avacta, Cytiva and BBI are in the process of technology transfer of the prototype and related manufacturing procedures for thetest. Avacta aims to begin clinical validation of the test as soon as possible using the first pilot batches.

Abingdon Health provides innovative rapid testing solutions to a global client base and has Europe's largest lateral flow test contract manufacturing capacity. Abingdon Health's two sites in York and Doncaster, UK are able to produce millions of rapid tests per month.

Technology transfer to Abingdon Health will begin immediately with the aim of manufacturing an equivalent rapid antigen test product which therefore does not require additional clinical validation/regulatory approvals. The agreement with Abingdon Health will provide additional manufacturing capacity that could increase to several millions of tests per month.

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

"I am delighted to have partnered with Abingdon Health to expand the manufacturing capacity for Avacta's rapid saliva-based COVID-19 test.

Authorities around the world are now looking to carry-out frequent mass testing to identify the most infectious people promptly in order to reduce infection rates and combat the coronavirus pandemic. That requires a highly specific test to minimize false positives which would otherwise overwhelm healthcare systems. The Affimer reagents that we have generated are very specific to SARS-CoV-2 antigen and we are confident of meeting and exceeding the clinical performance requirements for identifying the most infectious people.

Manufacturing capacity is therefore the key challenge that has to be met in achieving widespread roll-out of Avacta's saliva-based rapid antigen test. We therefore continue to actively seek additional manufacturing partners globally to be able to provide the volume of tests that will be required in the UK and elsewhere. I look forward to updating the market on progress in that regard, and will keep the market informed on the key next steps of clinical validation and regulatory approval."

Chris Yates, CEO of Abingdon Health commented:

"We are pleased to be working with Avacta on this saliva-based COVID-19 test. Abingdon Health is working at the forefront of COVID-19 rapid testing and we are delighted to expand our reach further to support deployment of mass testing to help in the fight to combat the COVID-19 global pandemic.

We have invested in our manufacturing capacity over the past few months and stand ready to support deployment of high volume, quality, rapid lateral flow tests."

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

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About Avacta Group plc - https://www.avacta.com

Avacta is developing novel cancer immunotherapies combining its two proprietary platforms - Affimer® biotherapeutics and pre|CISION™ tumour targeted chemotherapy. With this approach, the Company aims to address the lack of a durable response to current immunotherapies experienced by most patients. The Company's therapeutics development activities are based in Cambridge, UK.

The Company benefits from near-term revenues generated from Affimer reagents for diagnostics, bioprocessing and research, through a separate business unit based in Wetherby, UK.

The Affimer platform is an alternative to antibodies derived from a small human protein. Despite their shortcomings, antibodies currently dominate markets worth in excess of $100bn. Affimer technology has been designed to address many of these negative performance issues, principally: the time taken, and the reliance on an animal's immune response, to generate new antibodies; poor specificity in many cases; large size and cost.

Avacta's pre|CISION targeted chemotherapy platform, releases active chemotherapy only in the tumour, thereby limiting systemic exposure and damage to healthy tissues, and thereby improving the overall safety and therapeutic potential of these powerful anti-cancer treatments.

By combining these two platforms the Company is building a wholly owned pipeline of novel cancer therapies with the aim of creating effective treatments for all cancer patients including those who do not respond to existing immunotherapies. Avacta expects to take its first drug, a pre|CISION targeted form of the standard-of-care Doxorubicin, into the clinic later in 2020 or early 2021.

Avacta has established drug development partnerships with pharma and biotech, including with Moderna Therapeutics Inc., a deal with LG Chem worth up to $310m, a partnership with ADC Therapeutics to develop Affimer drug conjugates and has established a joint venture in South Korea with Daewoong Pharmaceutical focused on cell and gene therapies incorporating Affimer immune-modulators. Avacta actively seeks to license its proprietary platforms in a range of therapeutic areas.

Avacta diagnostics business unit works with partners world-wide to develop Affimers for evaluation by those third parties with the objective of establishing royalty bearing license deals. The Company is also developing a small in-house pipeline of Affimer-based diagnostic assays for licensing.

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About Abingdon Health

Abingdon Health is a technology-enabled lateral flow diagnostics company providing innovative rapid testing solutions to a multi-industry, global client base. Abingdon Health provides specialist assay development and smartphone reader solutions alongside Europe's largest lateral flow test manufacturing capacity. By combining a multi-disciplinary approach with precision automation, Abingdon Health assures product consistency and security of supply for the most complex of assays and markets. Abingdon Health takes projects from initial concept through scale-up and into high-volume manufacturing, in addition to accommodating clients looking to transfer their rapid test from third-party developers or manufacturers.