Avacta reports positive progress in chemotherapy trial
Oncology drug and diagnostics developer Avacta Group said in an update on Tuesday that ‘AVA6000’ was continuing to show a “very favourable” safety profile in the fourth dose cohort of the ALS-6000-101 dose escalation phase-one clinical trial.
The AIM-traded firm additionally said that analysis of tumour biopsies obtained from six patients across several cohorts indicated that doxorubicin was being released within the tumour tissue, confirming the tumour-targeting potential of its ‘preCISION’ technology.
It said AVA6000 was still being well-tolerated by patients in the fourth cohort, with a “marked reduction” in the incidence and severity of the typical toxicities associated with the standard doxorubicin chemotherapy administration.
Typical toxicities include alopecia, myelosuppression, nausea, vomiting, mucositis and cardiotoxicity.
It said that importantly, even at the highest dosing levels in the cohort - equivalent to more than double the normal dose of doxorubicin - the typical drug-related cardiotoxicity of doxorubicin was not observed.
A number of tumour biopsies obtained from patients in different cohorts were also analysed to confirm the release of the active chemotherapy, doxorubicin, in the tumour tissue.
Avacta said the analysis showed that AVA6000 was targeting the release of doxorubicin to the tumour tissue at therapeutic levels that were “much higher” than the levels being detected in the bloodstream at the same time point.
A total of 19 patients with a range of advanced or metastatic solid tumours enrolled across four cohorts had been administered AVA6000 to date.
On the basis of the “very favourable” safety profile of AVA6000 in the study so far, the safety data monitoring committee (SDMC) had recommended continuation to higher dose cohorts, with the aim of identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the phase-1b and future studies.
The company said it expected to complete those additional cohorts during the first half of 2023.
“We're delighted with the very positive data emerging from the dose escalation study of our lead preCISION tumour targeted therapy AVA6000,” said chief executive officer Alastair Smith.
“The very significant reduction in the usual toxicities, plus the observed release of doxorubicin at significant levels in the tumour tissue, show that the preCISION platform has the potential to significantly improve the safety and tolerability of chemotherapies, and other drugs, by targeting their release to the tumour.
“This is extremely encouraging as we work towards realising our vision of ‘chemotherapy without side effects’ to make a meaningful difference to cancer patients' lives.”
Dr Smith said Avacta was now in a position to proceed beyond the fourth cohort in the dose escalation study to even higher doses than originally anticipated, which he described as an “unexpected and very positive” development.
“The data being generated in the ALS-6000-101 study are providing detailed insights into the preCISION platform which add significant value to the technology and confirm the potential of the preCISION platform.”
At the close on Tuesday, shares in Avacta Group were up 12.17% at 154.8p.
Reporting by Josh White for Sharecast.com.