Core Insights - Avacta Therapeutics announced promising Phase 1 data for its lead program FAP-Dox (AVA6000), showing preliminary efficacy in salivary gland cancers and a favorable safety profile with no severe cardiac toxicity [1][3][4] - The Phase 1a study demonstrated a disease control rate of 91% in patients with salivary gland cancers, with median progression-free survival (PFS) not yet reached, indicating a significant improvement over previous benchmarks [5][6] - The proprietary pre|CISION platform targets fibroblast activation protein-alpha (FAPα), allowing for tumor-localized drug activation, which enhances efficacy while minimizing systemic toxicity [2][11] Clinical Data Highlights - AVA6000 was well-tolerated in a Phase 1a dose-escalation study, with no maximum tolerated dose reached despite dosing up to 385 mg/m² every three weeks [4][6] - In a cohort of 11 patients with salivary gland cancers treated at or above 250 mg/m², multiple confirmed responses were observed, and the median follow-up exceeded 25 weeks [5][7] - The exposure of released doxorubicin in plasma and normal tissues was lower than that of conventional doxorubicin, with a median tumor to plasma ratio of 100:1, further supporting its improved safety profile [6][11] Future Developments - Full Phase 1a data across all patients, including cardiac safety assessments, are expected in the second half of 2025 [7] - Avacta is enrolling patients in three Phase 1b expansion cohorts targeting salivary gland cancer, triple negative breast cancer, and high-grade soft tissue sarcoma, with data anticipated by the end of 2025 [7]