Avacta Group PLC has provided an update on the progress of its AVA6000 Phase 1a clinical trial. The trial involves a two-weekly dose escalation study of AVA6000, a peptide drug conjugate designed to target the release of the chemotherapy doxorubicin to tumor tissue. The pre|CISIONTM technology aims to reduce damage to healthy tissues and systemic side effects, improve tolerability for patients, and optimize dosing schedules to enhance efficacy.
The safety and tolerability of AVA6000 are being assessed in the Phase 1a dose escalation study. Data from the three-weekly dosing arm of the trial demonstrated that the pre|CISIONTM platform targets the release of chemotherapy to the tumor as intended, significantly improves the safety and tolerability of doxorubicin, and shows encouraging preliminary clinical signs of anti-tumor activity. Even at the highest dose level, dose-limiting toxicities were not observed, and the Safety Data Monitoring Committee concluded that this dose level is safe.
Based on the favorable safety profile, a two-weekly dosing safety study has commenced in the US, with three patients already dosed in cohort 1. Regulatory and ethics approval has been received to open sites in the UK for the two-weekly arm. The combined data from the three-weekly and two-weekly studies will help define the dose and schedule for future efficacy studies. Avacta remains on track to begin the dose expansion efficacy study in the second half of 2024.
Dr. Alastair Smith, Chief Executive Officer of Avacta Group, expressed satisfaction with the progress, stating that the emerging data demonstrate the functionality of the pre|CISION™ platform and its capability to target the release of cancer therapy to the tumor. He also highlighted the potential to apply pre|CISION™ to a range of warheads, including those more potent than doxorubicin.
The company is looking forward to providing a detailed update on the clinical trial at the American Association for Cancer Research meeting in April. Lee Cranmer, MD, PhD, FACP, expressed encouragement by the initial data with AVA6000 and looks forward to understanding the optimal dosing for this novel approach to targeted cancer therapy.
The update indicates significant progress in the development of AVA6000 and the wider pre|CISION™ platform, positioning Avacta to deliver substantial clinical and commercial milestones.