Sydney-based company GlyTherix has today announced that a consortium led by the company is the successful recipient of a competitive grant in Round 9 of the federal government’s Cooperative Research Centres Projects (CRC-P) program.
The grant will use the company’s proprietary novel target, Glypican-1, and its lead antibody to this target, Miltuximab, as a flagship molecule to develop national capability in manufacturing and distribution of radioimmuno-oncology drugs.
Radioimmunotherapy (RIT) uses antibodies to selectively deliver radiation to kill cancer cells while limiting damage to healthy cells.
Dr Brad Walsh, CEO of GlyTherix, said that widespread adoption of RIT has been traditionally limited by the complex manufacturing process and short shelf life of the radioisotope.
“The grant brings together Australian SMEs, universities and government research organisations to pioneer manufacturing of 'shake-and-bake' kits that allow on-site, on-demand production of RITs in hospital radiopharmacies.
"Our Miltuximab antibody will be used as a testbed for the entire production process, testing safety and efficacy in a Phase 1 clinical trial. This project not only builds out our data around the technology but will also lead the way for Australia to develop sovereign capability in antibody manufacturing and RIT kits. Ultimately, these kits will help facilitate expanding a theranostic approach to cancer treatment in many more hospitals and patients,” said Dr Walsh.
In this project radiolabelled Miltuximab is being used for both imaging and immunotherapy, known as ‘theranostics’.
The project partners include Australian Nuclear Science And Technology Organisation (ANSTO), Commonwealth Scientific And Industrial Research Organisation (CSIRO), Cytiva (formerly GE Healthcare Life Sciences), Auspep, University Of Technology Sydney and Macquarie University.
Dr Walsh said, “We are grateful to the Federal Government for recognising the internationally competitive potential in this application. It’s extremely exciting to be commencing our manufacturing and clinical trial program for Miltuximab with such an esteemed group of experts in their field from highly respected Australian and International companies and institutions,” said Dr Walsh.
“Theranostics is one of the most exciting areas of medicine and an area where Australia is a world leader. This CRC-P enables the diverse skills required to be assembled locally to benefit from our world leading position in this field of medicine. The pairing of a precision diagnostic with a corresponding precision therapeutic that targets Glypican-1 has the potential to treat a wide range of cancers. We are excited to be part of the program and looking forward to working on the antibody manufacturing process at UTS,” said Stephen O’Sullivan, business development manager – ANZ, Cytiva (formally GE Lifescience).
Professor Roger Chung from Macquarie University's Faculty of Medicine, Health and Human Sciences said the University was excited to be collaborating with GlyTherix and other consortia partners on this exciting translational research project.
“Through MQ Health, the University’s integrated academic health centre, we provide an important pathway for academic and industry-led technology to be evaluated in a healthcare setting towards clinical translation,” said Professor Chung.
According to the managing director of Auspep, Chris Chandler, “GlyTherix has done a great job in putting this CRC-P together. They have brought the right mix of knowledge from the industrial, government and academic sectors which will give the program it’s best chance of a successful, commercial outcome.”
Dr Andrew Groth, business development manager of UTS Faculty of Science, said the partnership was a globally significant development and the production of antibodies in the UTS Biologics Innovation Facility demonstrates the power of university and industry collaboration.
“UTS is extremely proud to be part of what is a landmark for the Australian biopharmaceutical industry with an end-to-end project from development to clinical trials,” he said.
“Radioimmuno-oncology is one of the most exciting and dynamic areas in nuclear medicine and radiochemistry, with robust research and commercial interest globally. This timely CRC-P will establish an end-to-end national capability for antibody-based theranostics in Australia, building our reputation as a global leader in nuclear medicine clinical trials. ANSTO is proud to be a participant in this project delivering to our core missions of improving the health of all Australians and supporting Australian business,” said Dr Nigel Lengkeek, senior radiochemist at ANSTO.