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Highlights
- Imugene Limited (ASX:IMU) has received human research ethics approval for Phase I human trial of anti-cancer oncolytic virotherapy VAXINIA
- Tasman Oncology Research, a comprehensive cancer hospital in South Australia, is the first hospital to receive ethics approval
- The patient screening will begin in January
- With HREC approval, IMU has won the first independent review of VAXINIA pre-clinical safety and efficacy data in Australia
A clinical-stage immuno-oncology company, Imugene Limited (ASX:IMU), has won Human Research Ethics Committee (HREC) approval to start Phase I clinical trial of its oncolytic virotherapy candidate, VAXINIA, in Australia. Following the update, IMU shares were spotted trading 6.25% higher at AU$0.170 per share at 11:16 AM AEDT today.
Ethics approval marks a significant milestone as it confirms that all the essential pre-clinical safety and efficacy testing of VAXINIA needed for human clinical trials in Australia has been completed by Imugene.
Details of the trial
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).”
Phase 1 trial is being conducted with the primary objective of measuring safety and an optimal biological dose of VAXINIA (CF33-hNIS) as a monotherapy and in combination with immune checkpoint inhibitors. The test will also analyse the efficacy, immune response, and tolerability of the City of Hope-developed oncolytic virus. In preclinical laboratory and animal models, it has been shown to shrink ovarian, colon, lung, breast, and pancreatic cancer tumors.
The Australian component of Phase I trial will be performed under Australia’s Clinical Trials Notification (CTN) Scheme. As part of the process, the Therapeutic Goods Administration (TGA) will be informed about the HREC approval by Imugene. Also, the company will complete local site initiation activities.
Tasman Oncology Research, a comprehensive cancer hospital located in Eastwood, South Australia, is the first hospital to receive ethics approval. Eventually, more clinical sites will be made available in the country. A similar process was seen in the United States after receiving investigational new drug (IND) approval from the Food and Drug Administration (FDA) a year ago.
Imugene expects the trial to be completed in about two years.
Data source: IMU update; Image source: © 2023 Krish Capital Pty. Ltd.