Peptide Drug Conjugate (PDC)
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Avacta Therapeutics Presents Compelling Phase 1a Data for Faridoxorubicin and the pre|CISION® Platform at the European Society of Medical Oncology Annual Congress
Globenewswire· 2025-10-19 14:00
Core Insights - Avacta Therapeutics has reported promising results from its Phase 1a clinical trial of faridoxorubicin (FAP-Dox, AVA6000), indicating a significant improvement in progression-free survival (PFS) for patients with salivary gland cancer, with a disease control rate of 91% [1][10] - The treatment demonstrated favorable safety and tolerability, with no severe cardiac toxicity observed even at cumulative doses up to 550 mg/m², which is approximately four times the conventional doxorubicin dose [2][12] Clinical Trial Results - Median PFS has not been reached in the cohort of patients with salivary gland cancers, suggesting a durable response, with follow-up data indicating a duration of PFS more than double that of benchmark data [3][10] - In the Phase 1a study, faridoxorubicin was well-tolerated across both every-three-week and every-two-week dosing regimens, with no maximum tolerated dose reached despite dosing up to 385 mg/m² [8][9] - The trial included 11 patients with salivary gland cancers, showing multiple confirmed partial and minor responses, and a median PFS follow-up of approximately 41 weeks [10] Safety Profile - Cardiac safety data revealed no severe cardiac events reported during treatment or follow-up, even at maximum cumulative exposure [12] - The study demonstrated that faridoxorubicin has a markedly improved safety profile over conventional doxorubicin, with only two patients showing echocardiogram changes consistent with adverse findings [12][9] Mechanism of Action - Faridoxorubicin is designed to reduce systemic side effects by concentrating the active drug in the tumor microenvironment, leveraging the pre|CISION platform [7][19] - The platform allows for the release of the drug specifically within the tumor, resulting in higher concentrations at the tumor site and lower levels in the bloodstream and healthy tissues [21] Future Developments - Avacta continues to enroll patients in the Phase 1b expansion cohorts, with further data in salivary gland cancer expected by the end of 2025 [15] - The company plans to present additional findings at the upcoming Investor Meet conference on October 21, 2025 [16]