Avacta Group plc says that AVA6000 continues to show a favorable safety profile in the fourth dose cohort of the ALS-6000-101 dose escalation phase 1 clinical trial.
Additionally, analysis of tumor biopsies obtained from six patients across several cohorts indicates that doxorubicin is being released within the tumor tissue. This confirms the tumor targeting potential of the pre|CISIONTM technology.
Avacta’s AVA6000 continues to be well tolerated by patients in cohort 4 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. Importantly, even at the highest dosing levels in cohort 4, equivalent to more than double the normal dose of doxorubicin, the typical drug-related cardiotoxicity of doxorubicin was not observed.
Tumor biopsies obtained from patients in different cohorts have also been analyzed to confirm the release of the active chemotherapy, doxorubicin, in the tumor tissue. This analysis showed AVA6000 targets the release of doxorubicin to the tumor tissue at therapeutic levels much higher than the levels being detected in the bloodstream at the same timepoint.
Nineteen patients with a range of advanced and/or metastatic solid tumors enrolled across four cohorts, have been administered AVA6000 to date. On the basis of the favorable safety profile of AVA6000 in the study to date, the Safety Data Monitoring Committee (SDMC) has 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 expects that it will complete these additional cohorts during the first half of 2023.
Avacta vision: ‘Chemotherapy without side effects’
Alastair Smith, chief executive officer of Avacta, said: “We’re delighted with the very positive data emerging from the dose escalation study of our lead pre|CISIONTM tumor targeted therapy AVA6000. The very significant reduction in the usual toxicities, plus the observed release of doxorubicin at significant levels in the tumor tissue, show that the pre|CISIONTM platform has the potential to significantly improve the safety and tolerability of chemotherapies, and other drugs, by targeting their release to the tumor.
“This is extremely encouraging as we work towards realizing our vision of “chemotherapy without side effects” to make a meaningful difference to cancer patients’ lives. We are now in a position to proceed beyond the fourth cohort in the dose escalation study to even higher doses than originally anticipated, which is an unexpected and very positive development. The data being generated in the ALS-6000-101 study are providing detailed insights into the pre|CISIONTM platform which add significant value to the technology and confirm the potential of the pre|CISIONTM platform.”