[source: Avacta]

Avacta Group (AVCT ) said it maintains a confident outlook amid “very significant progress” during the 1H21 period, 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. 

Dr Alastair Smith, CEO of Avacta said: “It has been a period of very significant progress for the Group and a transformative one for both the Diagnostics and Therapeutics Divisions.

The progress made during the reporting period has been extraordinary, as indeed it has been over the last 18 months, under very challenging circumstances for staff with regards to restrictions on working conditions and the effects of the pandemic on our lives outside work.”

Avacta Group developed the lateral flow test using its Affimer® platform to detect the coronavirus spike antigen. In April 2021, it released positive data from the clinical validation of the AffiDX® antigen lateral flow test which demonstrated 98% overall clinical sensitivity.   

Data from a study in Europe on 98 positive COVID-19 samples demonstrated an ‘excellent performance’ in identifying the SARS-CoV-2 virus across a broad range of viral loads.  

The clinical evaluation of Avacta’s lateral flow test, which tested 98 positive samples, was carried out at a single site in Europe with patient samples with viral loads confirmed by PCR.  

The test identified 96/98 of these correctly as positive with 20 minutes read time resulting in a clinical sensitivity of 98.0% for samples within this broad range down to low viral loads.  

Out of a total of 102 negative samples tested with the lateral flow device, the test correctly identified 101 as negative, giving a clinical specificity of 99.0%, the company told investors. 

Following the positive data, the Company submitted a declaration of conformity for CE mark for its AffiDX® SARS-CoV-2 antigen rapid test through its partner Mologic in early May 2021.

Post-period, Avacta reported that the Medicines and Healthcare products Regulatory Agency (“MHRA”) had confirmed the registration of its AffiDX® SARS-CoV-2 antigen lateral flow test, thereby allowing the group to place the product on the market in the UK for professional use.

Meanwhile, Avacta’s therapeutics division received approval from the MHRA for its phase I, first-in-human clinical study for AVA6000 pro-doxorubicin. Over the period, the Company commenced the dosing of its first patient at the Royal Marsden Hospital in August 2021.
In August 2021, Avacta said the first patient from its Phase I multi-centre trial evaluating AVA6000, a therapeutic product based on the pre|CISION™ technology has been dosed. 

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. 

The Company added that it believes its Diagnostics Division has the potential to generate significant revenue from sales of the AffiDX® SARS-CoV-2 antigen test over a longer period than originally anticipated, therefore creating the basis for a profitable Diagnostics Division. 

“In the next 12 months we expect to see further strong progress in both Divisions and anticipate several significant value inflection points to be achieved,” Avacta concluded. 

On Wednesday, Avacta said it had achieved a pre-clinical development milestone as part of its $400m multi-target therapeutics development partnership with LG Chem Life Sciences. 

Under the partnership, LG Chem has the exclusive rights to develop and commercialise, on a global basis, Avacta’s Affimer® PD-L1 inhibitor with Affimer XT® serum half-life extension.

LG Chem also has the right to develop and commercialise other Affimer® and non-Affimer biotherapeutics combined with Affimer XT® half-life extension for a range of indications.

Avacta could earn up to $55m in milestone payments for each of these new products.In addition, Avacta will earn royalties on all future Affimer XT® product sales by LG Chem.

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