Generics
Avacta Gains FDA Approval of its Investigational New Drug Application for AVA6000
30 November 2021 - - The US Food and Drug Administration has approved its Investigational New Drug application for AVA6000, UK-based clinical stage biopharmaceutical company Avacta Group plc (AIM: AVCT) said.

This will allow the Group to expand its Phase I clinical trial, ALS-6000-101, into clinical trial sites in the United States.

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 USD 1.38bn by 20241, are widely used as part of standard of care in several tumour types, but their use is limited by cumulative toxicity.

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

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.

The FDA has completed its 30-day review of Avacta's IND application, which was submitted ahead of schedule in October 2021, and has concluded that the Group may proceed with its proposed clinical investigation.

This allows Avacta to enroll eligible patients into US clinical trial sites for the company's Phase I multi-centre study, ALS-6000-101.

As previously announced in August 2021, the company 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.

Enrollment in US clinical trial sites is expected to begin in early 2022.

Provided that the study shows that the pre|CISION 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|CISION chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed USD 74bn by 20272.
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