Macquarie Medical Imaging was approached to facilitate this research project. As it turned out it was the very first Phase 1 first-in-human trial in our university and hospital campus. – post script MMI
In an all-Australian clinical trial, Macquarie University Hospital has completed a Phase 1, first-in-human trial testing the safety and tolerability of a Glypican antibody in the treatment of solid tumors.
The protein Glypican-1 (GPC-1) occurs in many solid tumours such as prostate, bladder, pancreatic, glioblastoma, oesophageal, ovarian and brain cancers.
The protein was first identified by Australian Biotechnology company, Minomic International Ltd. That Australian discovery has now progressed to a pioneering new therapy to determine whether a GPC-1 targeting antibody can be used to bind to GPC-1 cancer cells.
The therapy involves Miltuximab®, a chimeric version of Minomic’s anti-glypican 1 antibody conjugated to the radioactive isotope gallium. It is the first drug of its kind to target GPC-1. MQ Health Clinical Trials Unit has completed the pioneering first-in-human clinical trial of the antibody treatment – making it the first Australian-only trial of its kind. Medical oncologist Dr Dhanusha Sabanathan worked with the MQ Health Clinical Trials Unit and Minomic to draw up the protocol for the study that looked at bio-distribution and targeting.
“The trial’s primary endpoints are to assess safety and tolerability of the antibody,” explained Dr Sabanathan, who is conducting the trial as part of her doctoral thesis. “The secondary endpoints include evaluating the ability of the drug to target tumour and assessing the pharmacokinetics and biodistribution of the drug.”
“Recruitment to the Phase 1 trial has now been completed. Twelve patients participated with all patients tolerating the drug well and no drug-related adverse events being reported.” Macquarie Medical Imaging conducted the imaging for the trial, using its radiopharmaceutical capability and partnership with ANSTO, who conjugated the GPC-1 with gallium-67 for the trial.
Professor Howard Gurney, Principal Investigator and Head of the MQ Health Clinical Trials Unit, said that the overall direction of the long-term research is to test whether the chimeric anti-Glypican 1 antibody can be used as a safe anti-cancer therapy.
The team is now in discussion with Minomic – who specialises in therapeutics and diagnostics for solid tumours, including prostate, bladder and pancreas – about the next phase of the drug development.
“Through this trial, Macquarie University Hospital has demonstrated that we can conduct Phase 1 trials right here, without the need for using an American or European trials unit to complete Phase 1,” said Professor Gurney.
“Particularly in cancer trials, we now have the credentials to do Phase 1, 2 and 3 trials. Our collaboration with Minomic makes this a purely Australian trial and enhances Australia’s capability in conducting the full clinical trial process. This is good news for Australia.”
Author: Andrea Lewis; Photographer Tim Robinson. First published in FRONTIER Magazine, Summer 2019.
Feature Photograph: Dr Dhanusa Sabanathan and Prof. Howard Gurney