Sydney, Australia – July 22, 2023. GlyTherix Ltd (GlyTherix), an Australian immuno-oncology company specialising in developing antibody radiopharmaceuticals for solid tumours is pleased to announce a cornerstone investment by Cyclowest Holdings Pty Ltd (Cyclowest) in GlyTherix’s Series A round. Concurrently GlyTherix has entered into an exclusive Manufacturing, Supply & Distribution agreement with Cyclowest appointing it as its radiopharmaceutical production partner including supply of 89Zirconium (89Zr) and distribution of products in Australasia (SE Asia, NZ, South Pacific and Australia).
89Zr is a key diagnostic isotope used in GlyTherix’s portfolio of radioimmunotherapy (RIT) assets. The parties will initially focus on the production and distribution 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 with 177Lutetium (177Lu) being offered to qualifying patients.
GlyTherix, is raising capital in a Series A round to complete the Phase Ib study for its patented antibody Miltuximab®. It expects this to be the last raise prior to a planned IPO in 2024, with listing most likely to be on the ASX.
GlyTherix CEO, Dr Brad Walsh stated “Cyclowest is a highly regarded nuclear medicine company, currently in Australia, whose mission is to provide critical nuclear medicine products and services to the region. Their involvement as a reliable isotope supply, manufacturing and distribution partner for GlyTherix will add considerably to our commercialisation efforts. We are pleased to be working with such a trusted collaborator to include the supply of 89Zirconium, an important radioisotope with broad utility in the diagnosis of human cancers.”
Cyclowest Managing Director Dr Nat Lenzo said, “Cyclowest is excited to be partnering with another Australian company with innovative technology to help achieve their aims of producing novel diagnostic and therapeutic radiopharmaceuticals to aid in the future management of a number of cancers. We are especially pleased to be utilising our expertise in radiometals and equipment provided by the previous Federal Government’s Modern Manufacturing Initiative to provide 89Zr to Glytherix as the first part of what we hope will be a growing and mutually beneficial collaboration.”
GlyTherix will use Cyclowest’s 89Zr for its planned Phase 1b trials in Australia. The isotope will be used in combination with GlyTherix’s proprietary antibody, Miltuximab®, targeting tumours expressing Glypican-1 in a Phase Ib imaging and therapeutic dose escalation trial.
Cyclowest Holdings Pty. Ltd. is establishing a network of privately owned cyclotron facilities in Australasia, equipped to deliver a range of GMP (Good Manufacturing Practice) and TGA (Therapeutic Goods Administration) certified radiopharmaceuticals. With assistance from the previous Federal Government’s Modern Manufacturing Initiative Cyclowest’s first facility in Perth, Western Australia has the critical infrastructure necessary to provide commercial production of GMP radiometals such 89Zirconium.
Cyclowest Holdings will continue to look for commercial relationships and grant funding opportunities to establish facilities capable of serving patients locally, nationally and internationally with GMP radiopharmaceutical products.
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
Cyclowest: Dr Nat Lenzo, Managing Director, 0402 345 665