Avacta in Wetherby applies for clinical trial of drug that helps target tumours

In AVA6000, Doxorubicin has been modified with Wetherby-based Avacta's pre|CISION chemistry which renders the modified drug inactive in the circulation until it enters the tumour micro-enviornment where it is activated by an enzyme called fibroblast activation protein (FAP) which is in high abundance in most solid tumours but not in healthy tissue such as the heart.

AVA6000 has been shown in animal models to significantly increase the amount of active drug in a tumour compared with the heart and should thereby improve tolerability and achieve better clinical outcomes for patients.

The planned phase I study is a first-in-human, open-label, multi-centre study to be carried out in the UK in patients with locally advanced or metastatic solid tumours which are known to be FAP positive including pancreatic, colorectal, breast, ovarian, bladder and non-small cell lung cancers, squamous cell carcinoma of the head and neck and soft-tissue sarcoma.

The dose-escalation phase of the study, which will be carried out in 15-20 patients, is designed to evaluate the safety of AVA6000 in humans and establish the appropriate dosing levels for the dose expansion phase of the study.

Alastair Smith, CEO of Avacta Group, said: "I am absolutely delighted that we have achieved this landmark milestone for the pre|CISION platform and for the group.

"I would express my gratitude to our clinical development team led by Neil Bell who recently joined the group as chief development officer, as well as our collaborators at Tufts University, who have worked tirelessly to meet a demanding timeline under difficult conditions during the pandemic.

"The study will provide key information about the performance of the pre|CISION chemistry in humans that will underpin the value of a substantial pipeline of safer, next-generation chemotherapies.

"We have already begun development of pre|CISION pro-drug forms of Velcade, Oxaliplatin and Paclitaxel so that we can rapidly accelerate one or more of these assets into the clinic when we see the first read-out from the AVA6000 trial approximately four months into the dose escalation phase.

"We expect to receive feedback from the Medicines and Healthcare products Regulatory Agency (MHRA) on the Clinical Trial Application by February 2021.

"Dosing of first patients will commence when we have responded to that feedback and received approval to proceed. I look forward to updating the market on the detailed timing in due course."

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Thank you

James Mitchinson