CAMBRIDGE & WETHERBY, England– Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that the first patient has been dosed in its Phase I multicentre trial evaluating AVA6000, a novel pro-drug of Doxorubicin.
AVA6000 is Avacta’s first therapeutic based on its proprietary pre|CISION™ technology. The platform incorporates a substrate that is specifically cleaved by the protease fibroblast activation protein alpha (FAPα), which is upregulated in most solid tumours and at low background levels in healthy tissue, providing an activation mechanism to ensure localised release of chemotherapeutic agents from their pro-drug form. By activating chemotoxins only within the tumour microenvironment, systemic exposure to healthy tissues is limited, improving the safety and therapeutic potential of these cancer therapies.
Incorporating the pre|CISION™ platform, AVA6000 is a tumour-activated form of Doxorubicin. 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, particularly cardiotoxicity. Avacta’s pre|CISION™ pro-drug approach is designed to reduce the systemic exposure of healthy tissues to the active chemotherapy, leading to improved safety and therapeutic index, potentially resulting in improved dosing regimens, better efficacy and better outcomes for patients.
The AVA6000 study is a dose-escalation Phase I study in patients with locally advanced or metastatic selected solid tumours, known to be FAP-positive. These cohorts will receive ascending doses of AVA6000 to determine the maximum tolerated dose and establish a recommended Phase II dose. The second part of the study is an expansion phase where patients receive AVA6000 to further evaluate the safety, tolerability and clinical activity at this recommended Phase II dose across selected tumour types. For more information visit www.clinicaltrials.com (NCT04969835)
The first patient has received their first dose of AVA6000 at The Royal Marsden NHS Foundation Trust, London. The Phase I study is being initiated across a small group of leading UK oncology centres with an established reputation for early clinical research in cancer. The dose escalation phase is anticipated to complete by Q2 2022 followed by completion of the dose expansion phase by Q2 2023.
