Avacta moves to next dose in first-in-human chemotherapy trial

Clinical-stage oncology drug company Avacta announced on Thursday that the first-in-human phase 1 trial of ‘AVA6000’ pro-doxorubicin would advance to the next dose cohort, following a positive review of the safety data from the dosing of the first cohort.

The AIM-traded firm said its safety data monitoring committee, composed of clinicians currently recruiting patients, had completed its review of the safety data from the first cohort dosed with AVA6000 at 80 milligrams per square metre in the ongoing phase 1 trial.

Following that review, the committee recommended that the clinical trial continued as planned, and escalates to the next dose of AVA6000 at 120 milligrams per square metre.

Avacta described AVA6000 as a novel form of doxorubicin that had been modified with its ‘preCISION’ platform to improve its safety and therapeutic index.

Anthracyclines such as doxorubicin, a generic chemotherapy with a market size that was expected to grow to $1.38bn by 2024, were widely used as part of standard-of-care in several tumour types, but their use was limited by cumulative toxicity.

AVA6000 was designed to limit cell penetration of the drug, and thus its cell-killing effect, until it was specifically activated by fibroblast activation protein α (FAP), which is in high concentration in many solid tumours compared to healthy tissues.

The resulting reduced exposure of healthy tissues to active doxorubicin had the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression.

“We are delighted with the committee’s recommendation to move on to the next dose of AVA6000 in our dose escalation study following its positive review of the safety data from patients in the first cohort,” said chief executive officer Dr Alastair Smith.

“We are very excited by the potential of AVA6000, and the preCISION platform more broadly, to deliver ground-breaking and affordable cancer treatments that have the potential to significantly improve patients' lives.”

At 1203 GMT, shares in Avacta Group were up 9.78% at 90.4p.