Life sciences company Avacta Group PLC (AIM: AVCT) announced on Monday that it presented new Phase 1a data for its lead programme, faridoxorubicin (FAP-Dox, AVA6000), at the 2025 European Society of Medical Oncology (ESMO) Annual Congress in Berlin, demonstrating strong safety, tolerability and early efficacy signals.
Faridoxorubicin, developed using Avacta's proprietary pre|CISION platform, showed no maximum tolerated dose up to 385 mg/m²--approximately four times the conventional doxorubicin dose - with no severe cardiac toxicity reported even at cumulative doses of 550 mg/m². Across both every-two-week and every-three-week dosing regimens, treatment was well tolerated, with reduced toxicity compared to standard chemotherapy.
In patients with salivary gland cancers (n=11) treated at or above 250 mg/m², faridoxorubicin achieved a 91% disease control rate, including multiple confirmed partial and minor responses. Median progression-free survival (PFS) has not yet been reached, with current follow-up data suggesting PFS duration more than double that of benchmark studies, which report 3.5 - 4 months.
Activity was also observed in soft tissue sarcoma patients (n=17), with durable disease stabilisation and evidence of tumour responses at lower dose levels. Cardiac monitoring showed no severe events, even at cumulative exposures equivalent to the upper anthracycline threshold, reinforcing the therapy's improved safety profile.
Pharmacokinetic analyses indicated that plasma exposure to released doxorubicin remained lower than conventional dosing, while intratumoral concentrations were up to 100 times higher, confirming targeted activation within the tumour microenvironment.
Avacta continues enrolling patients in the Phase 1b expansion cohorts, with further data in salivary gland cancer expected by the end of 2025. The company will host an investor conference on 21 October 2025 to review the latest results.
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Avacta reports promising Phase 1a data for faridoxorubicin at ESMO 2025