Policy & Regulation
Avacta completes sixth dose escalation in AVA6000 Phase 1 trial
19 September 2023 -

UK life sciences company Avacta Group plc (AIM:AVCT) announced on Tuesday that it has successfully completed the sixth dose escalation cohort in the ALS-6000-101 Phase 1 clinical trial of AVA6000.

Designed to assess AVA6000's safety and tolerability, the trial has also shown encouraging results in terms of efficacy. One patient with soft tissue sarcoma demonstrated a significant reduction in tumour volume in response to the drug, with further signs of activity observed in patients with cancers not limited to soft tissue sarcoma.

AVA6000 is a tumour targeted 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 the active chemotherapy to tumour tissue.

The Safety Data Monitoring Committee has recommended continuation to the seventh dose cohort at 385 mg/m2, which is equivalent to approximately 3.5 times the standard dose of doxorubicin. This will be the final dose escalation cohort in the ALS-6000-101 Phase 1a safety study for three weekly dosing.

Avacta also said that the favourable safety profile of AVA6000 supports its potential for higher dosing and increased cycles compared to standard doxorubicin. A short study exploring fortnightly dosing of AVA6000 as a first-line treatment in soft tissue sarcoma patients is planned for Q4 2023, pending FDA protocol amendment approval.

In light of the positive data emerging from the ALS-6000-101 study, the company has adapted its clinical development strategy with the aim of bringing forward the start of a potentially pivotal phase 2 study in soft tissue sarcoma, subject to regulatory approval.

Detailed Phase 1a data from the ALS-6000-101 clinical study, encompassing clinical and pharmacokinetic data, is anticipated for release in Q4 2023.