Life sciences company Avacta Therapeutics (AIM: AVCT) announced on Monday that it presented compelling Phase 1 clinical data for its lead pre|CISION® candidate, FAP-Dox (AVA6000), at the 2025 American Association for Cancer Research Annual Meeting in Chicago.

FAP-Dox, a fibroblast activation protein-activated form of doxorubicin, demonstrated strong safety and preliminary efficacy, with no severe cardiac toxicity observed even at doses up to four times higher than conventional doxorubicin. In patients with salivary gland cancers treated at or above 250 mg/m², the disease control rate reached 91%, with median progression-free survival not yet reached after a median follow-up of 25.3 weeks. These results significantly outperform benchmark data presented at ESMO 2024, where similar patients had a median progression-free survival of 3.5 months.

Pharmacokinetic data showed a tumour to plasma doxorubicin exposure ratio of 100:1, highlighting effective tumour targeting and reduced systemic exposure. Full Phase 1a data across all patients, including comprehensive cardiac safety analysis, are expected in the second half of 2025.

Patient enrolment continues in three Phase 1b expansion cohorts across salivary gland cancer, triple negative breast cancer, and high-grade soft tissue sarcoma, with further data anticipated by the end of 2025.

Avacta Therapeutics is advancing a pipeline of pre|CISION peptide drug conjugates and Affimer drug conjugates, leveraging tumour-specific FAP activation to enhance efficacy and minimise toxicity in cancer therapies.