Avacta Group PLC
LONDON and PHILADELPHIA, Sept. 25, 2026 (GLOBE NEWSWIRE) -- Avacta Therapeutics (AIM: AVCT, the "Company", "Avacta"), a life sciences company developing innovative, targeted oncology drugs, today announces the presentation of the FOCUS-01 trial design and preclinical data highlighting the potential of AVA6103 (FAP-Exd) in pancreatic ductal adenocarcinoma (PDAC). FOCUS-01 is the Phase 1 trial of AVA6103, the Company's first Next-Generation pre|CISION® peptide-drug conjugate (PDC) and is being presented at the American Association for Cancer Research ("AACR") Conference on Pancreatic Cancer in San Diego, California, held between 25-28 September 2026.
The presentation highlights the design of the FOCUS-01 Phase 1 study of AVA6103 and updated preclinical data supporting the assessment of AVA6103 in patients with PDAC. AVA6103 is designed to significantly increase the therapeutic window of the highly potent payload, exatecan, and the trial implements a dose-dense arm, dosing every two weeks (Q2W), to enhance the delivery of payload to the tumor over traditional dosing of ADCs at every three weeks (Q3W). Preclinical studies using the dose-dense regimen in patient-derived xenograft (PDX) mouse models of PDAC demonstrate that AVA6103 achieved tumor-targeted delivery of exatecan with highly durable complete and partial responses in multiple models observed for weeks following cessation of dosing.
Additionally, researchers observed high FAP expression in PDAC with close proximity of FAP-expressing cancer-associated fibroblasts (CAFs) to both blood vessels and tumor cells, shown via multiplex immunofluorescence (mIF). These findings support the mechanism of action of the Next Gen pre|CISION medicines: efficient PDC delivery to the tumor, cleavage and release of payload with tumor cell uptake of released payload.
Christina Coughlin, CEO of Avacta, commented:
"The preclinical data presented at AACR underscore the significant potential of AVA6103 in addressing the challenges of pancreatic cancer, a disease with limited treatment options and poor prognosis. The robust preclinical efficacy, combined with the high FAP expression in PDAC, further strengthens our confidence in AVA6103 as a promising therapeutic candidate to improve treatment options for patients.
"This adds to the momentum of AVA6103 and highlights the potential of our unique pre|CISION® technology to bring hope to patients battling PDAC and other aggressive cancers. The first clinical data from the FOCUS-01 trial, providing clinical evidence consistent with tumor-specific delivery of exatecan by AVA6103, have further reinforced our confidence in this program and we are now moving towards an initial efficacy readout from the study in H1 2027."