Newcastle biotechnology company ImmVirX Pty Limited has treated the first cancer patient in the clinical trial of its bio-selected oncolytic virus, IVX037.

Newcastle biotechnology company ImmVirX Pty Limited has treated the first cancer patient in the clinical trial of its bio-selected oncolytic virus, IVX037.

ImmVirX is creating powerful new cancer immunotherapy combinations to transform outcomes for patients with some of the most prevalent and challenging cancer types such as colorectal cancer, ovarian cancer, gastric and pancreatic cancer.

These combinations (referred to as oncolytic viruses) target, infect and kills cancer cells.  As the infected cancer cells are destroyed by oncolysis, they release new infectious virus particles (or virions) to help destroy the remaining tumour.

Based at the Hunter Medical Research Institute (HMRI) and supported by the commercial arm of the University – The University of Newcastle Research Associates (TUNRA), ImmVirx was founded in 2019 by the team from Viralytics, which was sold for A$502 million in 2018 – the largest biotech sale in Australia’s history.

ImmVirX co-founder and University of Newcastle Professor Darren Shafren leads the 19-strong team of researchers working to develop the next-generation, receptor targeted oncolytic viral immunotherapies.

During the first-in-human, Phase 1a part of the study, IVX037 will 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, which will be conducted across four clinical centres in Australia, is to evaluate safety, tolerability and preliminary effectiveness of IVX037.   The trial will start 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.

University of Newcastle Deputy Vice-Chancellor (Research and Innovation), Professor Zee Upton, said the progression of the study into human trials was an exciting and promising milestone for the Newcastle researchers.

“The ImmVirx research team is potentially on the cusp of a medical breakthrough that could change the trajectory for cancer patients around the world who have limited treatment options.

“The University of Newcastle is proud to be a key player in supporting this important medical research that holds great promise in helping cancer patients live better, healthier lives,” Professor Upton said.”

ImmVirX CEO and Co-Founder, Dr Malcolm McColl, said it was a key milestone for ImmVirX and he was proud of the dedication and skill applied to enable the start of the important phase of the 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.”