On September 19, 2022 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that the Australian Government’s Office of the Gene Technology Regulator (OGTR) has granted Imugene the DIR licence required to expand its VAXINIA Phase 1 clinical trial within Australia (Press release, Imugene, SEP 19, 2022, https://mcusercontent.com/e38c43331936a9627acb6427c/files/62a3b420-798b-d7c4-4a34-5ff2a546823c/IMU.pdf [SID1234619663]).
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The licence, numbered DIR 192 and titled ‘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 multicenter Phase 1 VAXINIA trial commenced in May 2022 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. 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 models¹.
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)." 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 approximately 24 months and is funded from existing budgets and resources.
Imugene MD & CEO, Ms 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."