Avacta Group Regulatory News (AVCT)

30 September 2020

Avacta Group plc

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

Launch of SARS-CoV-2 BAMSTM Research Test

Affimer-based research assay launched alongside performance data published by Bruker

Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer® and pre|CISIONTM platforms, is pleased to announce that the BAMS assay to detect the SARS-CoV-2 virus has been launched as a research kit1 by its partner Adeptrix (Beverly, MA, USA) and the assay has been presented by Bruker Scientific (Billerica, MA, USA), a leading mass spectrometer manufacturer, in a new application note2.

The bead-assisted mass spectrometry ("BAMS") assay uses the Affimer reagents specific to the SARS-CoV-2 virus to capture the virus spike protein from the sample for rapid detection by mass spectrometry, using the installed base of these instruments in hospitals. Up to one thousand samples per day can be analysed by a single technician using BAMS, making BAMS a very attractive high throughput technique for COVID-19 diagnosis and research.

Adeptrix has launched a BAMS research assay kit incorporating Avacta's Affimer reagents in order to make this powerful tool available to researchers globally to support the fight against the coronavirus. Work carried out in parallel by Bruker, a leading mass spectrometer manufacturer with a significant installed base of instruments in hospitals globally, to assess the performance of the assay has been published by Bruker in a detailed application note.

Avacta continues to work actively with the UK government's CONDOR programme to clinically evaluate the coronavirus BAMS assay in order to obtain regulatory approval for diagnostic use. Avacta and Adeptrix are in discussions with mass spectrometer manufacturers with a view to establishing commercial partnerships to market the research use and diagnostic products.

Commercial details are not being disclosed but Avacta will receive a royalty on the SARS-CoV-2 BAMS research kit sales.

1. https://adeptrix.com/store#!/SARS-CoV-2-S1-GlycoproteinAssay/p/234586062/category=0 

2. https://www.bruker.com/fileadmin/user_upload/8-PDF-Docs/Separations_MassSpectrometry/Literature/ApplicationNotes/1881181_MT-128_SARS-CoV-2_Antigen_Assay_ebook.pdf

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

"I am delighted that the Affimer-based BAMS assay developed with Adeptrix is now available for scientists to use in their research into the coronavirus. A research use assay is the first step in commercialising this powerful Affimer-based coronavirus research and diagnostic tool and the clinical evaluation of the assay in the UK to support CE marking for diagnostic use is a very high priority for Avacta.

I am also very pleased indeed that Bruker has published their application note, providing considerable detail about the performance of the SARS-CoV-2 BAMS assay, clearly demonstrating the potential of this Affimer-based coronavirus mass spectrometry test and another important validation of the Affimer platform.

I look forward to updating the market on the clinical evaluation of the BAMS assay and on commercial progress in due course."

- Ends -

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).

For further information from Avacta Group plc, please contact:

About Avacta Group plc - 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 $100 billion. 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 in 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 $400 million, 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 Affimer reagents 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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