Clinical-stage immuno-oncology company Imugene (ASX: IMU) has announced that its Phase 1 MAST (metastatic advanced solid tumours) trial evaluating the safety of novel cancer-killing virus CF33hNIS (VAXINIA) has cleared cohort 4 of the intravenous arm of the monotherapy dose escalation study.
The company said it has also cleared IV cohort 2 of the combination study where VAXINIA is administered with MSD's checkpoint inhibitor drug pembrolizumab. Cohort 5 of the IV arm for the monotherapy dose escalation is now open, as is IV cohort 3 of the combination study.
Managing director and CEO Leslie Chong said, “As we near closer to opening and completing the final cohorts that were planned at the beginning of the trial, we have an opportunity to expand the trial by enrolling patients in additional cohorts for the monotherapy dose escalation component. This will provide us with a far more robust data set to analyse and speak to at the conclusion of the MAST study, and provide us with a stronger platform as we further the clinical development of CF33 and VAXINIA.”
The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard-of-care treatment.
The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models.
The company said the study aims to recruit up to 100 patients across approximately ten trial sites in the United States and Australia.