New Response in the FAP-Dox (AVA6000) Phase 1b Trial

Avacta Therapeutics (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs, today announces a new partial response observed in a patient with salivary gland cancer (SGC) in the dose expansion phase of the FAP-Dox (AVA6000) Phase 1b trial.

This further signal of antitumor activity in this disease setting is encouraging as the expansion cohort continues to enroll in the indication of salivary gland cancer. This patient is a 69-year-old male with metastatic salivary gland cancer.  His prior therapy includes surgery and radiation with no prior systemic therapy.  His combined tumor diameter was reduced at the first scan by almost 50%, qualifying as a partial response.

 Recent data presented by the Company at the American Association of Cancer Research (AACR) annual meeting in April 2025 described the Phase 1a cohort of patients with one confirmed partial response and multiple minor responses with a disease control rate of 91%.  At the time of the data cutoff, the median progression free survival had not been reached and the data are trending to a doubling of the benchmark PFS in this pretreated setting. Recent benchmark data were published at ESMO in 2024 (Licitra et al. ESMO Annual Congress 2024).  The unmet need in this rare tumor type is very high, with metastatic salivary gland cancer having no preferred standard therapy.

The Company plans to publish the final data from the AVA6000 Phase 1a in the second half of 2025.  Further, the Company will provide a business update on the date of the Annual General Meeting, on July 2, 2025.

Christina Coughlin, CEO Avacta commented:

“We are thrilled to see the antitumor activity of FAP-Dox (AVA6000) in this disease with no preferred standard therapy.  The high unmet need in this indication underscores the potential for FAP-Dox to have a meaningful impact to patients.  We are encouraged by this response and remain focused on delivering further updates in this setting later in 2025.”