JANESVILLE, WI – September 18, 2024- GlyTherix Ltd (GlyTherix) an Australian targeted radiotherapy company specializing in developing antibody radiopharmaceuticals for solid tumors today is pleased to announce a new global clinical supply agreement with Wisconsin-based SHINE Technologies, a pioneer in next-generation fusion-based technology and North America's largest producer of non-carrier added lutetium-177 (n.c.a. Lu-177) chloride. SHINE will supply its n.c.a. Lu-177 chloride, Ilumira, for use in GlyTherix's clinical trials focused on innovative treatments for aggressive and invasive cancers.
As GlyTherix advances its clinical trials using the medical radioisotope Lu-177, it is building a global supplier network with proximity to major global markets, capable of consistently delivering high-quality, n.c.a. Lu-177 to patients. SHINE will supply n.c.a. Lu-177 for use in GlyTherix’s clinical trials with a particular focus on the expansive U.S. market.
GlyTherix's radiotherapy combines Lu-177 with a molecule targeting Glypican-1, a protein in aggressive cancers, to deliver localized radiation while sparing healthy tissue. Their 177Lu-DOTA-Miltuximab® will enter Phase Ib trials in early 2025.
GlyTherix will use 177Lu-DOTA-Miltuximab targeting tumors expressing Glypican-1 in its planned Australian Phase Ib therapeutic dose escalation trial scheduled to commence early 2025. Glypican-1 is an attractive tumor target that occurs in several aggressive and invasive cancers including prostate, pancreatic, bladder, lung, glioblastoma and ovarian cancer.
Dr. Brad Walsh, GlyTherix’s Chief Executive Officer said, “SHINE’s investment in high-quality isotope production places them at the forefront of the radiopharmaceutical supply chain with particular strength in servicing the U.S. market. This supply agreement for the medical radioisotope Lu-177 adds to GlyTherix’s global clinical supplier network, which also includes a clinical supply agreement with the Australian Nuclear Science and Technology Organization (ANSTO)”.
Greg Piefer, SHINE founder and CEO added, “Our partnership with GlyTherix, a true pioneer in targeted radiotherapy, represents an important step in advancing next-generation cancer treatments. GlyTherix's innovative approach has the potential to transform cancer care for patients with some of the most challenging solid tumors. By providing a reliable supply of high-quality Ilumira, we're proud to support their groundbreaking work that could offer new hope to patients with limited treatment options."
SHINE's Ilumira is produced in the company's Cassiopeia facility in Janesville, Wisconsin - the largest of its kind in North America. With an initial production capacity of 100,000 doses per year and the potential for expansion to 200,000 doses annually, SHINE is well-positioned to meet the growing demand for Lu-177 in cancer therapies.
This partnership with GlyTherix marks another significant milestone in SHINE's mission to harness nuclear technology for human health. By providing a reliable, high-quality supply of Ilumira for innovative clinical trials, SHINE is playing a crucial role in advancing targeted radiotherapy. As SHINE continues to expand its production capabilities and pursue vertical integration in Lu-177 supply, collaborations like this have the potential to transform cancer treatment worldwide, offering new hope to patients facing aggressive and hard-to-treat cancers.
About SHINE Technologies
Headquartered in Janesville, Wisconsin, SHINE Technologies stands as an industry leader in next-generation fusion, deploying innovative fusion and fusion-based technology that seamlessly combines safety, cost-efficiency, and environmental responsibility.
Distinguished by its proprietary medical isotope production processes, SHINE is at the forefront of creating non-carrier-added lutetium-177, a vital component in cutting-edge medical treatments. Anticipating further advancements, the company's forward-looking vision includes the creation of molybdenum-99, a diagnostic tool that plays a pivotal role in medical procedures aimed at detecting heart disease and cancer.
SHINE's commitment to innovation extends beyond the realms of industry and healthcare. Drawing on its fusion-technology expertise, the company has set its sights on addressing one of energy's most complex challenges—nuclear waste recycling. With a comprehensive and visionary approach, SHINE is steadfastly driving advancements across multiple sectors, leaving an indelible mark on the domains of technology, healthcare, and sustainable energy solutions.
About GlyTherix
GlyTherix Ltd is an Australian targeted radiotherapy company specializing in developing antibody radiopharmaceuticals for solid tumors. Miltuximab® specifically targets Glypican-1, a protein found in solid tumors 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 Glypican-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, +61 413 231 296 or Brad.Walsh@glytherix.com
SHINE: press@shinefusion.com
