Rns Out17 Dec 2025 07:01
Faridoxorubicin (AVA6000) Phase 1b cohort demonstrates clinically meaningful tumor shrinkage in patients with salivary gland cancers
Preliminary Phase 1b data is in line with Phase 1a data reported at the European Society of Medical Oncology in September 2025
Combined disease control rate of 90% across both Phase 1a and Phase 1b patients with confirmed partial and minor responses observed
LONDON and PHILADELPHIA - December 17, 2025 - Avacta Therapeutics (AIM: AVCT), a clinical stage biopharmaceutical company developing pre|CISION®, a tumor-activated oncology delivery platform, today announced compelling new data in patients with salivary gland cancer (SGC) enrolled in the ongoing Phase 1b trial of faridoxorubicin (AVA6000). The data show confirmed partial and minor responses, consistent with data previously reported from the Phase 1a part of the study.
Faridoxorubicin is the first peptide drug conjugate (PDC) in Avacta's pipeline. It consists of doxorubicin conjugated with Avacta's proprietary pre|CISION® peptide and is specifically cleaved (released) by fibroblast activation protein-alpha (FAP), which is over-expressed in the tumor microenvironment, enabling targeted release of the doxorubicin payload.
SGC accounts for 6-8% of head and neck cancers, with approximately 2,500 cases diagnosed in the U.S. each year.1 SGC is a disease that does not respond to chemotherapy, has no standard therapy defined in the metastatic setting and a five-year survival rate of approximately 42%2 in advanced stage disease.
Avacta's recent data demonstrate continued robust and meaningful tumor shrinkage in patients with SGCs and a combined disease control rate of 90% across Phase 1a and Phase 1b patients.
Based on the preliminary favorable efficacy and safety data observed in the Phase 1b cohort in this part of the trial, enrollment will continue in this cohort with further data updates across the Phase 1a and Phase 1b cohorts expected in 1H 2026.
Christina Coughlin MD, PhD, CEO of Avacta, commented:
"These data continue to reinforce our belief in the transformative potential of our pre|CISION® peptide drug conjugates to expand the therapeutic index and increase the efficacy of highly potent therapeutics and further strengthens our confidence across our broader pipeline.
"SGC cancer is a devastating disease with no established standard of care treatment options. The clinically meaningful tumor shrinkage and prolonged progression free survival we have observed in the study highlight faridoxorubicin's potential as an important new treatment option for patients with SGC and other solid tumors. The Phase 1b data will mature as we continue to collect the survival data in this cohort.
"Translational data collected from this population continue to demonstrate the power of our pre|CISION® platform, with optimal payload release observed even at the lowest levels of FAP expression. T