On September 21, 2022 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that its Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has seen the first patient dosed as part of intravenous (IV) cohort 1 in the trial (Press release, Imugene, SEP 21, 2022, View Source [SID1234621307]).
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The dosing of this patient follows the recent announcement that intratumoral (IT) cohort 1 had cleared, paving the way for both cohort 2 of IT administration and cohort 1 of IV administration.
A multicenter Phase 1 trial, the VAXINIA Phase 1 MAST study has to date delivered a low dose 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 models.
The study aims to recruit 100 patients across approximately 10 trial sites in the United States and Australia. Earlier this week, Imugene announced it had received the DIR licence from the Australian Government’s Office of Gene Technology Regulator, allowing for expansion of the trial within Australia.
Imugene MD & CEO, Ms Leslie Chong said: "I’m very proud of our team and partners on the VAXINIA study who continue to push through the various requirements that come with running a clinical trial. We are eager to see the results from this new route of administration for the drug, in addition to that of the IT arm of the study."