Avacta Group PLC has presented interim results from the Phase 1 clinical trial of AVA6000 at the American Association for Cancer Research (AACR) annual meeting. AVA6000, the first peptide drug conjugate in the Avacta pipeline, has shown a favorable safety profile and has demonstrated clinical proof-of-concept by delivering high concentrations of doxorubicin to the tumor microenvironment (TME), resulting in multiple patient responses. The trial has shown promising results in patients with high levels of Fibroblast Activation Protein (FAPhigh), validating the pre|CISIONTM drug delivery platform.

The lead investigator, Professor Udai Banerji, expressed enthusiasm about the early findings, highlighting the opportunity to localize an effective chemotherapeutic agent to tumors using innovative technology and biomarker strategies, resulting in reduced side effects. Dr. Alastair Smith, CEO of Avacta, emphasized the potential of the pre|CISIONTM platform, stating that the data supports the belief that it could be a game changer in cancer treatment, allowing for better outcomes with reduced side effects.

The Head of Research and Development at Avacta, Christina Coughlin MD, PhD, highlighted the advantages of the peptide drug conjugate drug class, particularly the tumor-specificity of the release of doxorubicin through targeting FAP and the simplicity of the manufacturing process, which results in significant cost savings. The clinical data demonstrated that treatment with AVA6000 resulted in tumor responses with favorable tolerability in patients whose tumors over-expressed FAP (FAPhigh), supporting further development in specific indications with higher FAP expression and sensitivity to anthracyclines.

Avacta's pre|CISIONTM technology leverages the tumor-specificity of FAP expression by rendering a therapeutic warhead inert until it encounters FAP and is cleaved, releasing the active warhead into the TME. This targeted release aims to reduce damage to healthy tissues and systemic side effects, improving tolerability for patients and allowing for the optimization of the dosing schedule to improve efficacy.

In the Phase 1a Arm 1 of the trial, seven dose cohorts were completed, with all 42 patients enrolled being evaluable for safety and efficacy. Enrollment continues in the Phase 1 Arm 2 dose cohort. The data from the trial demonstrate clinical proof of concept for AVA6000 with multiple patient responses, supporting the further development of the drug in specific indications with higher FAP expression and sensitivity to anthracyclines.