Avacta reaches milestone in AVA6000 dose escalation

Avacta Group announced a significant milestone in its phase 1a dose escalation study of AVA6000, its lead ‘preCISION’ drug, on Thursday.

The AIM-traded company announced the dosing of the third patient in the initial cohort of the study, marking progress in developing innovative oncology drugs and diagnostics.

It described AVA6000 as a peptide drug conjugate engineered to target the release of chemotherapy specifically to tumour tissue.

The technology leverages the higher levels of fibroblast activation protein (FAP) found in many solid tumours compared to healthy tissues.

By rendering chemotherapy inert until it encounters FAP, the aim was to minimise damage to healthy tissues and reduce systemic side effects, ultimately enhancing patient tolerability and treatment efficacy.

The phase 1a dose escalation study aimed to assess the safety and tolerability of AVA6000.

Data from the three-weekly dosing arm of the trial, announced in December, indicated promising results.

AVA6000 demonstrated targeted release of chemotherapy to tumours, improved safety and tolerability of doxorubicin, and showed encouraging preliminary signs of anti-tumor activity.

Even at higher dose levels, such as in cohort seven of the three-weekly study, dose-limiting toxicities were not observed, affirming the safety of AVA6000.

Building on those positive findings, Avacta initiated a two-weekly dosing safety study in the United States, anticipating potential efficacy enhancements with the dosing schedule.

Three patients had already been dosed in cohort one of the two-weekly dose escalation study in the US, with regulatory and ethics approvals secured to open sites in the UK for the study arm as well.

Avacta said it expected the safety data monitoring committee (SMDC) to review the data from the two-weekly cohort one by the end of April.

The board said the combined data from both the three-weekly and two-weekly studies would guide the company in defining the dose and schedule for future efficacy studies.

Parallel dosing in the two-weekly dose escalation study was underway, with plans to start a dose expansion efficacy study in the latter half of 2024.

That expansion study would inform the selection of a single orphan indication for the subsequent phase two efficacy study.

Avacta said it was on track with its development timeline, aiming to advance the field of targeted oncology drugs while optimising patient outcomes.

“We are extremely pleased with the continued excellent progress of AVA6000 in the phase 1a dose escalation study,” said chief executive officer Dr Alastair Smith.

“These emerging data clearly demonstrate that the preCISION peptide drug conjugate platform is functioning in the way it was designed and is capable of targeting the release of a cancer therapy to the tumour.

“Targeted therapy that spares healthy tissues is a holy grail of oncology drug development and we believe we have a unique platform to target FAP-rich tumour tissues to deliver significantly better outcomes for patients and substantial value to our shareholders.”

Dr Smith said the continuing validation of the preCISION platform in the clinic underlined the company’s confidence in the opportunity to apply preCISION to a range of warheads, including those “much more potent” than doxorubicin.

“We are now in a very strong position to deliver significant clinical and commercial milestones relating to AVA6000 and the wider preCISION platform, and we are looking forward to providing a further detailed update on the clinical trial at the American Association for Cancer Research meeting in April.”

At 1245 GMT, shares in Avacta Group were up 0.86% at 53.15p.

Reporting by Josh White for Sharecast.com.