Avacta announces AVA6000 dose escalation results

Candidate is a cancer therapy that has been chemically modified with Avacta’s pre|CISION platform

Avacta – a company developing oncology diagnostics and drugs – has announced that the fifth dose escalation cohort regarding its ALS-6000 candidate.

The phase 1 research was evaluating the tolerability and safety of the therapy and continues to demonstrate a very favourable profile for the tumour-targeted chemotherapy. Indeed, a number of patients among this fifth cohort – and earlier groups – remain on treatment as their condition has not progressed further.

AVA6000 is a type of doxorubicin that has been chemically modified with Avacta’s pre|CISION platform. This process is designed to decrease systemic side effects by targeting the release of active chemotherapy within tumour tissue.

In spite of the high dose level in this latest study, which is around 2.25 times a typical dose of doxorubicin, AVA6000 remains well tolerated by patients. Meanwhile, there has been a clear reduction in the incidence and severity of the typical toxicities associated with standard doxorubicin chemotherapy provision.

Dr Alastair Smith, chief executive at Avacta, has been encouraged by the data: “The continued positive safety profile of AVA6000 at these dose levels compared with standard doxorubicin is remarkable. We are seeing a significant reduction in the incidence and severity of all doxorubicin side effects.”

He added: “Analysis of the tumour biopsies to date also confirms that enough doxorubicin is being released in the tumour to have a therapeutic effect. If even higher doses of AVA6000 are tolerated then this may make a significant difference to the outcomes for patients in the upcoming efficacy study.”

“We are keen to progress onto the phase 1b efficacy study as soon as possible following completion of the dose finding phase 1a study. The dose expansion phase 1b study will provide an initial evaluation of efficacy and of the relative improvement in patient outcomes and quality of life of different dosing regimens of AVA6000 compared with the standard doxorubicin regimen,” he concluded.

The latest cohort consisted of 29 patients with a range of advanced or metastatic solid tumours were dosed at clinical trial sites in the UK and US. Following the favourable safety profile of AVA6000, the Safety Data Monitoring Committee has now recommended continuation to the sixth dose cohort at 310mg/m2 – equivalent to 2.7 times the standard dose of doxorubicin.