First patient dosed in Avacta's 'AVA6000' trial

Clinical-stage oncology drug company Avacta Group announced on Wednesday that the first patient has been dosed in its phase 1 multicentre trial evaluating ‘AVA6000’, which it described as a “novel pro-drug” of ‘doxorubicin’, and its first therapeutic product based on the proprietary ‘preCISION’ technology.

The AIM-traded firm said anthracyclines such as doxorubicin, a generic chemotherapy for which the market was expected to grow to $1.38bn by 2024, were widely used as part of standard-of-care in several tumour types, but use was limited by cumulative toxicity, and in particular, cardiotoxicity.

It said its ‘preCISION’ pro-drug approach was 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 trial of AVA6000 is a dose-escalation phase 1 study in patients with locally-advanced or metastatic selected solid tumours, known to be FAP-positive, in which cohorts of patients will receive ascending doses of AVA6000 to determine the maximum tolerated dose and establish a recommended phase 2 dose.

It said the second part of the study would be an expansion phase, where patients would receive AVA6000 to further evaluate the safety, tolerability and clinical activity at the recommended phase 2 dose across selected tumour types.

The first patient received their first dose of AVA6000 at the Royal Marsden NHS Foundation Trust.

Avacta said the phase 1 study was being initiated across a small group of leading UK cancer centres, with an “established reputation” for early cancer clinical research in the phase 1 setting.

The dose escalation phase was expected to complete by the second quarter of 2022, followed by completion of the dose expansion phase by the second quarter of 2023.

“The initiation of the first-in-human phase 1 clinical study for AVA6000 marks the transformation of Avacta into a clinical-stage biopharmaceutical company,” said chief executive officer Dr Alastair Smith.

“It is an outstanding achievement by the team and we are extremely proud of what has already been achieved since the establishment of the collaboration with professor William Bachovchin at Tufts University Medical School to develop the ‘preCISION’ technology for tumour targeting.

“If the study shows that the preCISION technology is effective in reducing systemic toxicity of Doxorubicin in humans, then that would open up an extensive and proprietary pipeline for Avacta of next-generation preCISION pro-drug chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74bn by 2027.”

At 0943 BST, shares in Avacta Group were up 2.35% at 125.89p.