Avacta Group plc (AIM: AVCT), a leader in the life sciences sector specializing in innovative oncology drugs and diagnostics, has announced the completion of its sixth dose escalation cohort in the ALS-6000-101 Phase 1 clinical trial. The study aims to evaluate the safety and tolerability of AVA6000, a chemically modified form of doxorubicin, in patients with advanced and/or metastatic solid tumors.

The Safety and Efficacy Data

The data from the sixth cohort indicates an excellent safety profile for AVA6000, which has been well-tolerated by 35 patients in clinical trial sites in both the UK and the United States. Notably, a patient with soft tissue sarcoma showed a significant reduction in tumor volume. Further, clinical activity in patients with various other indications has also been observed. The Safety Data Monitoring Committee (SDMC) has advised proceeding to the seventh dose cohort, with a dose of 385 mg/m2, approximately 3.5 times the standard dose of doxorubicin.

What is AVA6000?

AVA6000 is developed using Avacta’s pre|CISION platform and is designed to target the release of active chemotherapy to tumor tissue while minimizing systemic side effects. The patients in the sixth cohort received a dose 2.79 times higher than the typical dose of doxorubicin and showed clinically significant reductions in the toxicities usually associated with standard doxorubicin chemotherapy.

Clinical Development Strategy Adaptation

In light of these encouraging results, the company has updated its clinical development strategy to bring forward a pivotal phase 2 study in soft tissue sarcoma, subject to regulatory approval. This study aims to determine the recommended dosing regimen for phase 2 and could possibly provide additional indications of activity in soft tissue sarcoma patients. It will replace the initially planned Phase 1b efficacy study and aims to expedite the start of the phase 2 efficacy study to 2024.

Dr. Alastair Smith, the CEO of Avacta Group plc, stated, “I believe that we are on the verge of a paradigm shift in how chemotherapy is delivered to cancer patients.” He added that the company plans to accelerate the clinical development of AVA6000 and aims to start the phase 2 efficacy study earlier than initially planned.

  ALS-6000-101, AVA6000, Avacta Group, doxorubicin, Dr. Alastair Smith, soft tissue sarcoma