How Avacta has transformed into a clinical stage biopharmaceutical company

Drug developer Avacta has announced that the first patient has been dosed in the Phase I multi-centre trial evaluating AVA6000, a novel pro-drug of Doxorubicin and Avacta's first therapeutic product based on its proprietary pre|CISION technology.

Dr Alastair Smith said the clinical study for AVA6000 marks the transformation of Avacta into a clinical stage biopharmaceutical company.

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, and, in particular, 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.

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

The Phase I study is being initiated across a small group of UK cancer centres with an established reputation for early cancer clinical research in the Phase I setting.

The dose escalation phase is anticipated to complete by the second quarter of 2022 followed by completion of the dose expansion phase by the second quarter of 2023.

Dr Alastair Smith, CEO of Avacta, said: "The initiation of the first in human Phase I clinical study for AVA6000 marks the transformation of Avacta into a clinical stage biopharmaceutical company.

“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 pre|CISION technology for tumour targeting.

“We are delighted to be working on the AVA6000 study with global key opinion leaders in oncology drug development at world-class oncology clinical trial sites in the UK on this important pro-drug approach to improving the safety and efficacy of chemotherapies.

"If the study shows that the pre|CISION 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 pre|CISION pro-drug chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74bn by 2027."

Neil Bell, chief development officer at Avacta Life Sciences, said: "AVA6000 offers an exciting opportunity to improve upon the current doxorubicin treatment paradigm for patients, either as a monotherapy or in combination.

“We look forward to the results from our AVA6000 first-in-human clinical trial as we strive to improve the therapeutic index of doxorubicin for patients."

AVA6000 principal investigator Professor Udai Banerji, deputy director of the Drug Development Unit at The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust, said: “I am delighted that the first patient has now received AVA6000 in the first-in-human study.

“This drug harnesses our understanding of the tumour microenvironment to enhance drug delivery - targeting potent anticancer therapies to tumours and potentially sparing patients debilitating side effects.

“It is fantastic that efforts are being made to discover and develop smarter, kinder treatments."

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