Imugene Limited announced it has received Human Research Ethics Committee (HREC) approval to commence a Phase I clinical trial of its oncolytic virotherapy candidate, VAXINIA in Australia. Ethics approval is confirmation Imugene has completed all the necessary pre-clinical safety and efficacy testing of VAXINIA required to commence human clinical trials in Australia. The Australian component of the Phase I trial will be conducted under Australia's Clinical Trials Notification (CTN) Scheme meaning Imugene will notify the Therapeutic Goods Administration (TGA) of HREC approval and complete local site initiation activities.

The first hospital to receive ethics approval is Tasman Oncology Research, a comprehensive cancer hospital located in Eastwood, South Australia. Additional clinical sites will be opened in Australia, as have already been in the US following a Food and Drug Administration (FDA) investigational new drug (IND) approval 12 months ago. The primary aim of the Phase 1 trial is to determine safety and an optimal biological dose of VAXINIA (CF33-hNIS) as a monotherapy and later in combination with immune checkpoint inhibitors.

Efficacy, tolerability and immune response will also be measured. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumors in preclinical laboratory and animal models.