Melbourne-based ImmVirX says first patient dosed in trial of its bio-selected oncolytic virus

Latest News

Melbourne-based clinical-stage oncology company ImmVirX has announced that the first patient has been dosed in its two-part Phase 1 clinical trial of its bio-selected oncolytic virus, IVX037.

The company was founded in late 2019 by a team from Viralytics. Viralytics was an ASX-listed oncolytic virus company acquired in 2018 by MSD for A$502 million. ImmVirX is focused on developing next-generation, receptor-targeted oncolytic viral immunotherapies.

It said that in the first-in-human, Phase 1a part of the study, IVX037 would be assessed in patients with late-stage colorectal, gastric or ovarian cancer, three of the most prevalent cancer types globally.

The goal of Phase 1a is to evaluate the safety, tolerability and preliminary markers of efficacy following intratumoral administration of IVX037.

The trial will commence with a dose frequency escalation period with nine to 12 patients treated with one to three doses of IVX037, followed by a cohort expansion stage with a further 15 patients treated at the recommended dosing regimen.

Phase 1b of the study will assess the recommended dosing regimen of IVX037 in up to 45 patients when combined with an immune checkpoint inhibitor.  

ImmVirX CEO and co-founder Dr Malcolm McColl said, “This is a key milestone for ImmVirX and I am proud of the dedication and skill applied to enable the commencement of this important study. IVX037 has been developed by our highly experienced team based in our facilities in the Hunter Medical Research Institute in Newcastle.

"The agent has demonstrated safety and efficacy in preclinical studies. Having only commenced operations in the first quarter of 2020 we are excited to enter the clinic and assess IVX037 in colorectal, gastric and ovarian cancer patients where there is a high unmet need for better therapies. We look forward to providing updates on clinical progress during the year.”