Avacta Therapeutics had announced that the first patient has been treated in the FOCUS-01 trial, the multicenter, open-label Phase 1 clinical trial of FAP-Exd (AVA6103) in adults with selected advanced cancers. Avacta has very recently announced a £10 million fundraise by way of an oversubscribed placing and subscription to extend the Company's cash runway into early First Quarter 2027, expected to provide sufficient funding beyond the initial clinical data readout on AVA6103. The FOCUS-01 Clinical Trial The Phase 1a dose escalation portion of the FOCUS-01 clinical trial will evaluate the safety, tumor and plasma pharmacokinetics, pharmacodynamics and preliminary efficacy of AVA6103 in patients with one of four solid tumors in the advanced setting: pancreatic cancer, cervical and vulvar cancer, gastric and gastroesophageal junction cancers, and small cell lung cancer.
The selection of these initial four tumor types for the dose escalation portion of the trial was based on an AI approach investigating the co-expression of a gene that can predict sensitivity to the topoisomerase 1 inhibition mechanism (SLFN11) and FAP as part of the Company's strategic collaboration with Tempus AI. The data mining team ranked solid tumor indications based on the gene expression profiles to predict those cancer indications with the highest probability of success. The trial is expected to enroll approximately 144 patients and is designed to identify a dose and regimen for further clinical development using a Bayesian statistical method.
The Bayesian Optimal Interval (BOIN) design accelerates data collection through flexible cohort management while minimizing the probability of improper dose selection in the two arms of the trial, designed to investigate two dosing schedules (with every 3 weeks and every 2 weeks arms dosing in parallel). The first three centers open for enrollment in the FOCUS-01 study are the Virginia Cancer Specialists (VCS) Research Institute in Fairfax, Virgina, NEXT Oncology Specialists in Dallas, Texas, and START Midwest Center for Oncology Research in Grand Rapids Michigan.
