Avacta Group Regulatory News (AVCT)

01 May 2020

Avacta Group plc

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

COVID-19 Antigen Diagnostic Collaboration with Adeptrix

Second partnership to exploit the recently generated Affimer binders to the SARS-COV-2 virus in a high throughput COVID-19 antigen test

Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has entered into a collaboration with Adeptrix (Beverly, MA, USA) to develop a high throughput COVID-19 antigen test using Adeptrix's proprietary bead-assisted mass spectrometry (BAMS™) platform.

Avacta and Adeptrix will collaborate to develop and manufacture an Affimer-based BAMS coronavirus antigen test that will provide clinicians with a significant expansion of the available testing capacity for COVID-19 infection in hospitals.

Adeptrix's novel BAMS platform combines enrichment of the sample to improve sensitivity with the power of mass-spectrometry to improve specificity. Hundreds of samples per day can be analysed by a single technician using BAMS, exceeding the capacity of single PCR machine, making BAMS a very attractive high throughput technique for COVID-19 screening in the clinical setting.

The diagnostic test will allow hospitals around the world to utilise their existing installed base of mass spectrometers that are not currently used for COVID-19 testing, thus contributing significantly to the increase in global testing capacity. Avacta's recently developed Affimer reagents that bind the SARS-COV-2 spike protein will be used to provide the capture and enrichment of the virus particle from the sample which could be saliva, nasopharyngeal swabs or serum.

Development of a BAMS test capable of diagnosing whether a person has the COVID-19 infection at any specific moment is a quick process and the companies are aiming to have a BAMS test ready for clinical validation, regulatory approval and manufacturing in June. Adeptrix and Avacta are already in discussion with large-scale manufacturing partners to rapidly deploy this new high throughput test.

Further commercial details are not being disclosed but Avacta will receive a royalty on the sales of BAMS test kits by Adeptrix.

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

"We are delighted to have established this partnership with Adeptrix in our push to develop Affimer -based COVID-19 antigen tests. Jeff and his team are world-renowned in the mass spectrometry field, and the BAMS diagnostic platform is highly sensitive and specific, giving us great confidence that a high performance COVID-19 antigen test can be developed and launched commercially very quickly.

We believe that the BAMS test will be hugely attractive as an adjunct to PCR testing because it uses laboratory equipment that is already in hospital labs but not currently used for COVID-19 testing so it provides incremental testing capacity.

A consensus view is building around the world that hundreds of millions of COVID-19 tests are going to be required per month for a long period, and that the disease will be endemic after the initial pandemic has passed, meaning that testing for COVID-19 is going to be needed for many years.

I have made it clear that we intend to partner the SARS-COV-2 spike protein Affimer reagents with several select companies to support antigen test development on multiple diagnostic test platforms. This will contribute most effectively to the urgent need to increase antigen testing capacity globally and maximise the commercial return to Avacta. Adeptrix is one example of this and other discussions are underway. I look forward very much to further updating the market in the near future."

Dr. Jeffrey C. Silva, Director of Product Development, Adeptrix Corporation commented:

"I am pleased to have Avacta recognise the promise of the BAMS technology with respect to its sensitivity, accuracy and high throughput capacity. I have worked with Affimers previously and have found them to be excellent immunoassay reagents, so we are looking forward to quickly implementing the SARS-COV-2 Affimers in a BAMS diagnostic test.

Mass spectrometry can enhance the diagnostic utility of immunoassays, as it is capable of monitoring both existing and emerging viral strains by accurately measuring the molecular components of the virus. BAMS provides an ideal multiplexing platform to obtain higher specificity for monitoring COVID-19 infection.

We are excited to be working with Avacta to rapidly develop BAMS tests and supply them to clinical diagnostic laboratories."

THE INFORMATION COMMUNICATED IN THIS ANNOUNCEMENT IS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 596/2014.

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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 in late 2020.

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 Adeptrix

Adeptrix Corporation provides proteomic and diagnostic products using its proprietary BAMSTM platform which is a novel tool for targeted, multiplexed proteomics combining bead-based affinity enrichment with the power of mass spectrometry.

For further information: www.adeptrix.com