Imugene Ltd (ASX:IMU, OTC:IUGNF) welcomes news that its VAXINIA oncological treatment candidate has cleared an Australian regulatory requirement and a Phase 1 clinical trial can now be expanded to Australia.
The Australian Government’s Office of the Gene Technology Regulator (OGTR) has granted the DIR licence that the clinical-stage immuno-oncology company requires to expand the trial.
Australian hurdle cleared
The licence – 'Clinical trial of a genetically modified (GM) chimeric Orthopoxvirus (CF33-hNIS) as a cancer treatment' – is required as part of the Australian regulatory framework for dealings involving the intentional release of genetically modified organisms into the environment.
Imugene’s multicentre Phase 1 VAXINIA trial kicked off in May at US sites, 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.
Virus shrinks certain tumours
The oncolytic virus, developed at the City of Hope, has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models.
The Phase 1 clinical trial will look at the dose escalation, safety and tolerability of VAXINIA when administered intratumorally or intravenously, alone or in combination with pembrolizumab, and will target metastatic or advanced solid tumours.
Overall the study aims to recruit 100 patients across approximately 10 clinical trial sites in the United States and Australia.
The trial is anticipated to run for about 24 months and is funded from existing budgets and resources.
Imugene MD and CEO Leslie Chong said: “We’re pleased to see this regulatory hurdle cleared on schedule which will allow the smooth progression of our VAXINIA Phase 1 trial as planned.”