Imugene Ltd (ASX:IMU, OTC:IUGNF) plans to expand its Phase 1 metastatic advanced solid tumours (MAST) trial to target bile duct tumours, further advancing the evaluation of its novel cancer-killing virus CF33-hNIS (VAXINIA) following initial successes and a recent FDA Fast Track designation.
"Following the positive news on VAXINIA's early signals and FDA Fast Track Designation to end 2023, we are pleased to start the new year by announcing the ongoing progress of the MAST trial as we continue to see no safety issues with the drug," said Imugene managing director and chief executive officer Leslie Chong.
"We also look forward to expanding the trial to take a closer look at bile duct cancer where we've seen early encouraging results."
Dosing higher dose patients
The Phase 1 trial has continued to progress going into 2024, with the first of 38 patients enrolled to date dosed for both the higher dose monotherapy and combination arms.
The first patients of Cohort 5 of both the intratumoural (IT) and intravenous (IV) arms of the monotherapy dose escalation study were dosed on January 16 and 18, respectively.
Additionally, the combination study, which investigates VAXINIA in conjunction with pembrolizumab, continues to actively enrol new patients, with 13 signed up so far.
No safety concerns so far
The multi-centre Phase 1 MAST trial commenced by administering low doses of VAXINIA to patients with advanced solid tumours who had exhausted at least two prior treatments.
With no safety concerns identified so far, the trial has progressed through the monotherapy dose escalation and combination study arms.
The City of Hope-developed CF33 oncolytic virus has shown promising pre-clinical activity against various cancers, including colon, lung, breast, ovarian and pancreatic tumours.
The MAST trial aims to recruit up to 100 patients across around10 trial sites in the United States and Australia.
Imugene expects the trial, funded through existing resources, to run for about 24 months.