[source: Avacta]

The clinical stage biopharmaceutical company Avacta Group (AVCT ) has confirmed that its AffiDX® antigen lateral flow test can detect the Omicron variant of the SARS-CoV-2 virus. 

The Omicron (B.1.1.529) variant, with more than 35 mutations of the original SARS-CoV-2 virus, first appeared in South Africa a few weeks ago and was subsequently designated a variant of concern by the World Health Organisation (WHO) on 26 November 2021.

The UK has now reported over 3,000 cases of this more infectious variant of the virus.

Avacta, which develops cancer therapies and diagnostics using its proprietary Affimer® and pre|CISION™ platforms, said AffiDX® has been shown to detect Omicron in clinical samples.

The SARS-CoV-2 antigen lateral flow test was evaluated at the Carlos III Hospital in Madrid using a small number of actual patient samples confirmed to be Omicron variant positive.

The results indicated that the AffiDX® antigen test can detect the new Omicron variant in addition to all previously identified new variants of concern of the SARS-CoV-2 virus.

Commenting, Dr Alastair Smith, Chief Executive Officer of Avacta Group, outlined: “We are delighted to confirm that the AffiDX® SARS-CoV-2 antigen lateral flow test detects the Omicron variant. As this variant is more infectious, it is important that it can be detected in individuals with higher loads using lateral flow tests so that its spread can be slowed down.”

Currently, the Company explained that it is progressing with its application to the CTDA in order to put the AffiDx product on the market in the UK, as well as continuing to pursue commercial opportunities in Europe and further afield for the professional-use test. 

In addition, Avacta is workin with Medusa 19 Healthcare, to obtain a CE mark for consumer self-testing which it describes as “a critical next step in the commercialisation of the product.”

Avacta’s Diagnostics Division is currently developing an in-house pipeline of Affimer-based diagnostic assays, including the AffiDX® SARS-CoV-2 Lateral Flow Rapid Antigen Test, and works with partners world-wide to develop bespoke Affimer® reagents for third party products.

Last month, Avacta Group announced that it had received approval from the US FDA for its Investigational New Drug application in regard to the company’s therapeutic drug AVA6000. 

The US FDA approval means the clinical stage biopharmaceutical group will be able to expand its Phase I clinical trial of AVA6000 into clinical trial sites in the US in early 2022.

Avacta’s IND application was submitted ahead of schedule in October 2021. Upon review, the FDA has concluded that Avacta may proceed with its proposed clinical investigation to enrol eligible patients into US clinical trial sites for a Phase I multi-centre study of ALS-6000-101.

In recent weeks, Avacta has begun recruiting and dosing patients for this study at several clinical trial sites in the UK, and continues to expect the dose escalation phase for this trial to complete by 2Q22 followed by completion of the dose expansion phase around mid-2023.

The company said enrollment in US clinical trial sites is expected to begin in early 2022. 

At the end of September, Avacta said it maintained a confident outlook amid “very significant progress” during 1H21, particularly within the firm’s Diagnostics and Therapeutics Division. 

Over the period, revenues increased to £2.3m up from £1.8m in 1H20. Operating loss came to £11.3m compared to £8.1m in 1H20 while the Group’s increased investment into research and development led to reported loss of £10.2m compared to £7m in the prior 2020 period.

By period end, cash and short-term deposits stood at £37m compared to £54.5m in 1H20.

The biopharmaceutical firm described the six months to 30 June 2021 as “transformative” for its diagnostics division, which become an ISO 13485 accredited in-vitro diagnostic (IVD) products business and saw the first sales of its AffiDX® SARS-CoV-2 antigen lateral flow test. 

Commenting on Avacta’s outlook, Smith told investors that “significant value inflection points lie ahead”. He outlined that this included the Group’s potential to transform cancer therapy with the next generation of safer preCISION™ chemotherapies and Affimer immunotherapies. 

Avacta said it believes its most significant near-term value driver will be the clinical data from the phase I study of AVA6000. It said the pre|CISION prodrug approach ‘has the potential to complement chemotherapy and to create new oncology treatments that are affordable for all.’

If the study proves successful, Avacta expects to see a ‘significant commercial opportunity’ and ‘a large, and very valuable, pipeline of future pre|CISION™ chemotherapy prodrugs.’

In particular, Avacta said this would come with “significant clinical and commercial advantages” in a chemotherapy market that is expected to exceed $74 billion by 2027. 

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