Avacta Group Regulatory News (AVCT)

06 August 2020

Avacta Group plc

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

COVID-19 Rapid Antigen Test Manufacturing Partner

Avacta appoints BBI Solutions as manufacturing partner for the rapid SARS-CoV-2 antigen test being developed with Cytiva

Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has appointed BBI Solutions, part of BBI Group ("BBI"), to manufacture the saliva-based rapid SARS-CoV-2 antigen test that is being developed with Cytiva.

BBI Solutions is a leading global developer and manufacturer of raw materials and finished test products for the in-vitro diagnostics market, with manufacturing sites in five different countries, spanning four continents.

The manufacturing agreement between Avacta and BBI comprises the accelerated development and validation of a scaled-up manufacturing process that has the potential to ramp up to a production capacity of millions of tests per month. Avacta, Cytiva and BBI are in the process of the technology transfer of the prototype and related manufacturing procedures for the saliva-based rapidSARS-CoV-2 antigen test from Cytiva to BBI.

Avacta aims to begin clinical validation of the test as soon as possible by using the first pilot batches generated as part of the technology transfer process for these studies. In parallel with these clinical validation studies, which will be run within the UK government's CONDOR programme and potentially with other collaborators globally, BBI will work with Avacta and Cytiva to produce the additional technical documentation that is required for CE marking of the final product.

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

"I am delighted to be working with BBI to manufacture the rapid COVID-19 test. BBI has been excellent to work with to define a highly compressed product development timeline that will allow us to get the product to market as quickly as possible.

We anticipate very high demand for the COVID-19 rapid test and will be working with our preferred manufacturing partners at BBI to satisfy that demand. We are actively continuing our discussions with other manufacturing partners to ensure that we have access to additional manufacturing capacity to address the global need for SARS-CoV-2 antigen testing both now, and in the next few years.

As we set out in the use of proceeds at the recent fund raising, we have now expanded our product development team with the appointment of an experienced in-vitro diagnostic Product Development Manager, and we are expanding the protein production facilities in order to meet the expected demand for Affimer proteins for the COVID-19 tests and future diagnostic tests in the pipeline.

The diagnostics business has also been working at a rapid pace towards ISO13485 accreditation, which will streamline CE marking and other regulatory approval processes.

I am immensely proud of what has been achieved by Avacta's diagnostics team. Their progress in just a few months would have been challenging under normal circumstances, but with the additional restrictions imposed by COVID-19, it has been an outstanding example of hard work, ingenuity and commitment from a world-class team.

I look forward to further updating the market as we go through the next stages of manufacturing scale-up, clinical validation, regulatory approval and product launch."

Dr. Mario Gualano, Chief Executive of BBI Group:

"BBI are delighted to have been appointed to lead the manufacture of Avacta's rapid coronavirus antigen test, and to be able to further extend our lateral flow expertise to addressing the global challenges presented by COVID-19.

Our ability to respond rapidly to Avacta's needs is testament to our team's diagnostic expertise and the supporting manufacturing and quality systems we have implemented at our ISO13485 accredited facility."

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).

- Ends-

For further information from Avacta Group plc, please contact:

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.

To register for news alerts by email go to www.avacta.com/investor-news-email-alerts

About BBI Solutions - https://bbisolutions.com/

BBI Solutions has served the global diagnostics industry for over 50 years, as a leading developer and manufacturer of biological reagents and finished test platforms for the in-vitro diagnostics market. BBI is a global business with manufacturing sites and sales offices across four continents.

BBI's range of raw materials includes human antigens, antibodies, serum and plasma products and clinical chemistry enzymes. BBI manufactures world renowned labels for lateral flow, ELISA assay and biosensors, including gold nanoparticles and glucose oxidase.

BBI Solutions offers lateral flow development and manufacturing services with a core focus on antibody development, gold conjugation, lateral flow test manufacture and mobile diagnostic solutions with Novarum™ technology.

BBI Solutions is part of the BBI Group.