On January 9, 2023 Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, reported that it has received Human Research Ethics Committee (HREC) approval to commence a Phase I clinical trial of its oncolytic virotherapy candidate, VAXINIA in Australia (Press release, Imugene, JAN 9, 2023, View Source [SID1234626003]).
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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 clinical trial is titled "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)." The trial is anticipated to run for approximately 24 months and is funded from existing budgets and resources.
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 models1.
Imugene MD & 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."