Imugene Ltd (ASX:IMU, OTC:IUGNF) has received Human Research Ethics Committee (HREC) approval to kick off an Australian Phase 1 clinical trial of its oncolytic virotherapy candidate, VAXINIA (CF33-hNIS).
Ethics approval confirms the company has met all the necessary pre-clinical safety and efficacy testing of VAXINIA required to commence human clinical trials in Australia.
The Phase 1 trial will be conducted under Australia’s Clinical Trials Notification Scheme, meaning Imugene will notify the Therapeutic Goods Administration (TGA) of HREC approval and complete local site initiation activities.
Trial to kick off in South Australia
The first hospital to receive ethics approval is Tasman Oncology Research, a comprehensive cancer hospital in Eastwood, South Australia.
Additional clinical sites will open across the country, following the US, where the company received Food and Drug Administration (FDA) investigational new drug (IND) approval 12 months ago.
The trial, named 'A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)', is expected to run for 24 months, funded from existing budgets and resources.
The primary aim of the trial is to determine safety and an optimal biological dose of the drug as a monotherapy and later in combination with immune checkpoint inhibitors.
Efficacy, tolerability and immune response will also be measured.
Cancer-shrinking potential
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.
Imugene MD and CEO Leslie Chong said: “The start of our Australian study is a significant milestone for Imugene and clinicians treating Australians faced with the challenge of advanced solid tumour cancers.
“Accomplishing this goal speaks to the perseverance and dedication of Imugene’s clinical and research team as we continue to build on our clinical and commercial potential.
“In addition to the positive preclinical results, we’re incredibly eager to unlock the potential of VAXINIA and the oncolytic virotherapy platform for Australians inflicted with cancer.”