Avacta Group (AVCT) Study Update summary

Mechanism and Platform Overview

• AVA6000 (faridoxorubicin) uses a FAP-activated drug delivery system to target doxorubicin release within tumors, minimizing systemic toxicity and enabling prolonged treatment.

• The bystander effect allows released drug to affect both FAP-positive and adjacent tumor cells, enhancing tumor exposure while limiting blood exposure.

• The pre|CISION® platform enables tumor-specific release of doxorubicin via FAP cleavage, supporting broad applicability even in low-FAP tumors.

Study Design and Patient Population

• Phase 1a and 1b trials enrolled patients with salivary gland cancers, including those with high and heterogeneous FAP expression.

• Phase 1b included 22 SGC patients (median age 63), with most having prior therapy; 19 were evaluable for efficacy.

• Across both phases, 30 patients treated at 250 mg/m² and above were evaluable for efficacy.

• Primary endpoint was safety; secondary endpoint was efficacy by FAP level.

Safety and Tolerability

• AVA6000/faridoxorubicin demonstrated a favorable safety profile, with no Grade 3/4 cardiac toxicities and low rates of severe neutropenia.

• Dramatic reductions in GI and hematologic toxicities were observed compared to conventional doxorubicin.

• Four patients reached maximum cycles at 550 mg/m² with no severe cardiac toxicity.

• Safety profile in Phase 1b was consistent with Phase 1a, with no new safety signals.