Avacta gets approval for new cancer drug trial

The Wetherby-based group has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for a Clinical Trial Authorisation (CTA) in the UK for a phase I study of its lead pre|CISION pro-drug, AVA6000 pro-doxorubicin.

The new cancer drug, AVA6000, has been modified to make it inactive in the body's circulation until it enters a cancer tumour.

Once it enters the tumour, it is activated by an enzyme called FAP (fibroblast activation protein), which is in high abundance in most solid tumours, but not in healthy tissue such as the heart.

In animal tests, AVA6000 has significantly increased the amount of active drug in a tumour compared with the heart and has significant potential to achieve better clinical outcomes for patients.

The research will be a first in-human 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.

Avacta said the timing of dosing the first patient in the study may be affected by the ongoing Covid-19 pandemic and its effect on hospital resources. However, it is anticipated that the study will start around mid-year.

Alastair Smith, chief executive of Avacta Group, said: “I am delighted to receive this approval for the AVA6000 Pro-doxorubicin phase I study from the MHRA.

"This is a significant milestone for Avacta and opens the path to a potentially transformational clinical proof-of-concept study for AVA6000 and the pre|CISION platform.

"If the AVA6000 study shows that the pre|CISION chemistry is effective in reducing systemic toxicity of doxorubicin in humans, then it can be applied to a range of other established chemotherapies to improve their safety and efficacy.

"This would open up a pipeline of next generation chemotherapies for the group with significant clinical and commercial value in a chemotherapy market that is expected to grow to $56 billion by 2024."

Analyst Mark Brewer at FinnCap said: "Confirmation that the MHRA has given CTA approval for Avacta to start its first clinical study with AVA6000 (pro-doxorubicin) is a major milestone – transforming the therapeutics business into a clinical stage company and further de-risking the pre|CISION platform.

"Having filed the CTA on 23 December 2020, this will allow Avacta to start a Phase I study in a range of cancers to establish safety, tolerability and early efficacy signals.

"Covid-19 restrictions permitting, Avacta is targeting first patient dosing in mid-year, which should generate first data in the second half of 2021.

"A successful phase I outcome would see a substantial uplift in our target valuation."