Sydney, Australia – 10 Oct 2023. GlyTherix Ltd (GlyTherix), an Australian immuno-oncology company specialising in developing antibody radiopharmaceuticals for solid tumours is pleased to announce that it has entered into a Collaborative Research Agreement with the South Australian Health and Medical Research Institute Limited (SAHMRI) including the Molecular Imaging and Therapy Research Unit (MITRU).
Under the agreement the partners will leverage the know-how and expertise of MITRU to refine radiolabelling manufacturing methods for 89Zirconium (89Zr)-DFO-Miltuximab® and 177Lutetium (177Lu)-DOTA-Miltuximab® for GlyTherix’s upcoming Phase 1b clinical trial. Furthermore, the collaboration will evaluate the use of these radiolabelled drugs in several non-clinical oncology models.
The parties will initially focus on the radiopharmaceutical manufacturing and characterisation of 89Zr-Miltuximab® for imaging of cancer patients expressing Glypican-1 using Positron Emission Tomography (PET), as well as use in GlyTherix’s upcoming Phase Ib study. Glypican-1 is expressed in several aggressive and invasive cancers including prostate, pancreatic, bladder, lung, glioblastoma and ovarian cancer. GlyTherix’s proprietary antibody, Mituximab®, labelled with 89Zr will be used as an imaging agent to select patients showing tumour targeting, followed by a therapeutic dose of Miltuximab® labelled 177Lu with being offered to qualified patients.
GlyTherix CEO, Dr Brad Walsh stated “This important collaboration with SAHMRI marks an important milestone to refine our manufacturing methods for GlyTherix’s upcoming Phase 1b to demonstrate efficacy and further safety evidence for Miltuximab®. We are pleased to be working with such a trusted collaborator that has a strong history in research, development and manufacturing of radiopharmaceuticals and more broadly, further enhance Australia’s status as world leader in the advanced manufacturing of diagnostic and therapeutic nuclear medicines to help treat current and emerging diseases“.
Professor Maria Makrides, Executive Director of SAHMRI, said “For GlyTherix to choose to partner with SAHMRI and MITRU for this potentially life-saving initiative is a great show of confidence in our world-class capabilities. We are extremely proud of our MITRU team, which not only produces diagnostic and curative radiopharmaceuticals each and every day of the year, but is dedicated to innovation in developing the next generation of products that can improve healthcare for the betterment of people everywhere”.
GlyTherix will use 89Zr-DFO-Miltuximab and 177Lu-DOTA-Miltuximab targeting tumours expressing Glypican-1 for its planned Australian Phase Ib imaging and therapeutic dose escalation trial scheduled to commence later this year. Glypican-1 is an attractive tumour target that occurs in several aggressive and invasive cancers including prostate, pancreatic, bladder, lung, glioblastoma and ovarian cancer.
SAHMRI is South Australia’s flagship, independent health and medical research institute. It is home to more than 700 medical researchers from across the globe who work together to overcome the biggest health challenges facing society today. Find out more here.
GlyTherix Ltd is an Australian immuno-oncology company specializing in developing antibody radiopharmaceuticals for solid tumours. Miltuximab® specifically targets GPC-1, a protein found in solid tumours such as prostate, bladder, pancreatic, glioblastoma, oesophageal and ovarian cancers, and is not present in healthy tissue. The company has a strong proprietary and Intellectual Property position covering both Miltuximab® and the antigen GPC-1. This provides robust and long-term protection for the commercialization of important new treatments to people with little hope.
GlyTherix has completed a ‘First-in-Human’ trial of 12 patients using Miltuximab® with no drug-related adverse. Miltuximab® will be used in a Phase Ib trial as an antibody theranostic. GlyTherix is interested in partnerships or collaborations with larger biotech and pharmaceutical partners.
For more information regarding this release please contact:
GlyTherix: Dr Brad Walsh, CEO, 0413 231 296 or Brad.Walsh@glytherix.com
SAHMRI: Pete McDonald, Head of Media & Communications, 0402 293 078 or Pete.McDonald@sahmri.com