On June 21, 2023 Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, reported that the fifth dose escalation cohort in the ALS-6000-101 dose escalation Phase 1 clinical trial to evaluate the safety and tolerability of AVA6000 has been completed successfully (Press release, Avacta, JUN 21, 2023, View Source [SID1234632834]). The data continue to show a very favourable safety profile for the tumour targeted chemotherapy and several patients in cohort 5 and earlier cohorts remain on treatment as their disease has not progressed.
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AVA6000 is a form of doxorubicin that has been chemically modified with Avacta’s pre|CISION platform designed to reduce systemic side effects by targeting the release of active chemotherapy in tumour tissue. Despite the high dose level in the fifth cohort which is approximately 2.25 times a typical dose of doxorubicin, AVA6000 has continued to be well tolerated by patients with a marked reduction in the incidence and severity of the typical toxicities associated with the standard doxorubicin chemotherapy administration.
The emerging positive safety and pharmacokinetic data from the study support the potential clinical differentiation of AVA6000 over doxorubicin. This includes: (i) higher dosing of AVA6000 compared to standard doxorubicin, (ii) more frequent dosing of AVA6000 compared to doxorubicin – doxorubicin is typically dosed every three weeks in order for patients to recover from the side effects of treatment, (iii) the ability to administer many more cycles of AVA6000 compared to doxorubicin.
A total of 29 patients with a range of advanced and/or metastatic solid tumours have now been dosed at the clinical trial in sites in the UK and United States. On the basis of the very favourable safety profile of AVA6000 in the study to date, the Safety Data Monitoring Committee (SDMC) has recommended continuation to the sixth dose cohort at 310 mg/m2, which is equivalent to 2.7 times the standard dose of doxorubicin. This continued dose escalation is aimed at identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the Phase 1b and future studies.
Dr Alastair Smith, Chief Executive of Avacta Group plc commented: "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. 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."