Positive initial data from first Affimer-based rapid test strips for SARS-COV-2 spike protein

Avacta Group plc, the developer of Affimer® biotherapeutics and reagents, is pleased to announce that the first Affimer-based rapid test strips to detect SARS-COV-2 spike protein have been developed and evaluated by Avacta’s partners at Cytiva (formerly GE Healthcare Life Sciences) and show positive initial performance data.

In mid-May Avacta provided Affimer reagents that are specific to the SARS-COV-2 spike protein to Cytiva which has now developed the first lateral flow test strips using these reagents and generated initial performance data using coronavirus spike protein.

These data show that the test strips detect the spike protein in model samples at concentrations within the clinical range found in saliva of patients with COVID-19. Work continues now to refine the test strip design, optimise its performance and get the best detection limit possible in order to generate the highest sensitivity in the final rapid test product.

Following the optimisation of the lateral flow test by Cytiva the design will then be transferred to manufacturing partners in the UK that are currently being put in place by Avacta. The Company is working with these manufacturers to compress the normal manufacturing, clinical validation and regulatory timelines in order to bring a product to market as quickly as possible.

Dr. Alastair Smith, Chief Executive of Avacta Group commented: “I am delighted with the progress made by our partners at Cytiva and very encouraged by the positive data from the first test devices. We now need to optimise the test performance to achieve the best possible limit of detection as this will ultimately play a significant factor in determining the clinical sensitivity of the test.

This is a really positive step and we aim to have completed the optimisation very soon so that we can begin the transfer to manufacturers. I will be updating the market on progress in due course.”

Klaus Hochleitner, Global Lead, Technology Product Specialist at Cytiva, commented: “I am pleased that the test development has progressed from a working initial design to now focussing on optimising the test as much as possible. The Affimer reagents have worked well in lateral flow test strips and we are very encouraged by the initial data.”

About Avacta Group plc

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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