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Avacta Group (AVCT ) has received approval from the US Food and Drug Administration 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 enroll 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. 

Dr Alastair Smith, Chief Executive Officer of Avacta Group, stated: “This is a major milestone in our development of pre|CISION™ chemotherapies and is testament to the performance of our clinical development team and the quality of the pre-clinical data for AVA6000.”

ALS-6000-101 is a Phase I study in patients with locally advanced or metastatic selected solid tumours, known to be FAP-positive, in which patients receive ascending doses of AVA6000 to determine the maximum tolerated dose and establish a recommended Phase II dose.

The second part of the study of ALS-6000-101 is an expansion phase where patients will receive AVA6000 to evaluate the safety, tolerability and clinical activity at this recommended dose across selected tumour types.The dose escalation phase for this study is anticipated to complete by 2Q22 followed by completion of the dose expansion phase by 2Q23, it noted.

The company’s therapeutic drug AVA6000 is a novel form of doxorubicin that has been modified with Avacta’s pre|CISION™ platform to improve its safety and therapeutic index. 

Anthracyclines such as doxorubicin, a generic chemotherapy for which the market is expected to grow to $1.38bn by 2024, are widely used as part of standard of care in several tumour types, but their use is limited by cumulative toxicity, the company explained to shareholders.

AVA6000 has been designed by Avacta Group ‘to limit cell penetration of the drug, and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein α (FAP) which is in high concentration in many solid tumours compared with healthy tissues.’

The AIM-listed company explained to investors that the resulting reduced exposure of healthy tissues to active doxorubicin has the potential to ‘significantly increase’ its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression.

Commenting on the potential of the Phase 1 study, Smith added: “Provided that the study shows that the pre|CISIONTM technology is effective in reducing systemic toxicity of Doxorubicin, then that would open up an extensive and proprietary pipeline for Avacta of next-generation pre|CISIONTM chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74bn by 2027.”

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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