GPC1

SYDNEY, AUSTRALIA and LITTLE ROCK, AR / ACCESSWIRE / January 3, 2025 / GlyTherix Ltd (GlyTherix), an Australian targeted radiotherapy company, and 3D Imaging LLC (3DI), a Contract Development and Manufacturing Organization (CDMO) specializing in radiopharmaceuticals, are pleased to announce the execution of a Master Service Agreement. This collaboration combines 3DI\'s cutting-edge radiopharmaceutical manufacturing expertise with GlyTherix\'s innovative antibody therapies, advancing cancer treatments in the U.S. market.Partnership at a Glance: Revolutionizing Cancer TreatmentManufacturing Agreement: 3DI will produce GlyTherix\'s targeted radiotherapy antibody products, ^89^Zr-Miltuximab® and ^177^Lu-Miltuximab®, for upcoming U.S. clinical trials.Advanced Facilities: 3DI\'s state-of-the-art cGMP facility in Little Rock, Arkansas, featuring dual-beam cyclotrons and specialized hot cells, will serve as the central manufacturing site.Radionuclide Production: 3DI will supply its cyclotron-produced GMP 89-Zirconium oxalate.Strategic Location: 3DI\'s proximity to the Global FedEx hub ensures efficient distribution.Expanded Scope: The partnership supports potential future product distribution in the Asia-Pacific region.Dr. Marc Berridge, President of 3D Imaging, commented, \"3DI advances global healthcare by developing and producing quality radiopharmaceuticals. We\'re excited to support GlyTherix in bringing their innovative Miltuximab® products to U.S. clinical trials and distribution.\"Dr. Brad Walsh, CEO of GlyTherix, added, \"We are very excited to continue strengthening GlyTherix\'s development, supply and manufacturing efforts, distinguishing ourselves from the current generation of radiopharmaceuticals that have many logistical limitations due to very short half-lives. Through preclinical and clinical studies, GlyTherix is establishing itself as a leader in the advanced manufacturing of diagnostic and therapeutic nuclear medicines to improve treatment outcomes for adults with cancer.\"About 3D Imaging LLC: Founded in 2001, 3D Imaging LLC leads in radiopharmaceutical development and manufacturing. Our Little Rock, Arkansas, facility features dual-beam cyclotrons and specialized hot cells, producing radionuclides like Zr-89, Cu-64, F-18, and I-124 for a wide range of pharmaceutical companies in their research and clinical trials.About GlyTherix Ltd: GlyTherix develops targeted radiopharmaceuticals for solid tumors. Our lead product, Miltuximab®, targets Glypican-1, a protein expressed in various aggressive cancers including prostate, pancreatic, bladder, lung, glioblastoma, and ovarian cancer. The company has completed a \"First-in-Human\" trial with no adverse effects and is preparing for a Phase Ib therapeutic dose escalation trial in early 2025. GlyTherix is currently raising funds in a Series B raise and is interested in partnerships or collaborations with larger biotech and pharmaceutical partners.For more information, please contact:3D Imaging LLC: Dr. Marc Berridge, President, +1 501-353-2883, [email protected]GlyTherix: Dr. Brad Walsh, CEO, +61 413 231 296, [email protected]This press release contains forward-looking statements. Actual results may differ materially from those projected in the forward-looking statements.Contact InformationDr. Marc Berridge President[email protected]+1 501-353-2883Dr. Brad Walsh CEO[email protected]+61 413 231 296SOURCE: 3D Imaging LLC

VALENCIA, Calif. and SYDNEY, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Nusano, a physics company transforming the production of radioisotopes, and GlyTherix Ltd (GlyTherix), an Australian targeted radiotherapy company specializing in developing antibody radiopharmaceuticals for solid tumors, today announced a supply agreement for non-carrier-added lutetium-177 (Lu-177). The agreement also provides GlyTherix access to Nusano’s future actinium-225 (Ac-225) production, currently scheduled to begin in 2026, and planned future production of zirconium-89 (Zr-89), lead-212 (Pb-212) and terbium-161 (Tb-161). GlyTherix's radiotherapy approach combines Lu-177 with an antibody targeting Glypican-1, a protein found in aggressive cancers, to deliver localized radiation while sparing healthy tissue. Glypican-1 is an attractive tumor target that occurs in several aggressive and invasive cancers including prostate, pancreatic, bladder, lung, glioblastoma, esophageal and ovarian cancer. GlyTherix plans to use 177Lu-DOTAMiltuximab® in its planned Australian Phase Ib in 2025, followed by US Phase II trials in 2026. “GlyTherix is building a global network of radioisotope suppliers to support our clinical trials and ongoing research,” said Dr. Brad Walsh, CEO of GlyTherix. “We share Nusano’s enthusiasm for the future of radiopharmaceuticals and appreciate their focus on bringing supply stability to the market so more patients can access clinical trials and treatments.” Radioisotopes are essential components in the active pharmaceutical ingredients (API) used in new and emerging cancer therapies. Existing supply chains for these treatment-enabling resources are often strained, posing a risk to patient care, clinical trials, and ongoing drug development. “Nusano is working to enable multiple industries by making radioisotopes available and abundant,” said Chris Lowe, CEO of Nusano. “Our production of lutetitum-177 begins in early 2025 and will scale rapidly to meet the growing needs of drug developers, researchers and patients. We are honored to work with GlyTherix look forward to supporting their current and future efforts.” About NusanoNusano is a privately held physics company committed to bringing stability and innovation to the rapidly emerging and critically undersupplied medical radioisotopes market. Nusano’s proprietary ion source is smaller and more efficient than existing production methods. This results in significantly greater yields and allows for the simultaneous manufacturing of multiple radioisotopes. Nusano’s technologies will supply the fight against cancer and support diagnostic and therapeutic radiopharmaceutical development. The company’s state-of-the-art production facility opens in 2025 in West Valley City, Utah. For more, please visit www.nusano.com. 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, esophageal 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 events. 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. Contacts: Nusano Media: Scott Larrivee, Nusano, 608-345-6629, scott.larrivee@nusano.comInvestor Relations: Joyce Allaire, LifeSci Advisors, LLC, 212-915-2569, jallaire@lifesciadvisors.com GlyTherix Dr. Brad Walsh, CEO, +61 413 231 296 or brad.walsh@glytherix.com

Facebook Twitter LinkedIn Exciting News in Targeted Radiotherapy! GlyTherix Ltd has signed a global clinical supply agreement with Eckert & Ziegler, a leader in isotopes for nuclear medicine. This collaboration will provide GMP-grade Lutetium-177 chloride for GlyTherix’s clinical trials, aimed at treating aggressive cancers through innovative antibody radiopharmaceuticals. GlyTherix’s approach utilizes Lu-177 combined with an antibody targeting Glypican-1, a protein prevalent in several aggressive cancers, allowing for localized radiation treatment while protecting healthy tissue. Clinical trials are set to kick off in Australia in early 2025, followed by U.S. trials in 2026. Dr Brad Walsh, CEO of GlyTherix, emphasized the importance of this partnership in further strengthening their global supply network, ensuring high-quality isotopes are available for patients. Dr. Harald Hasselmann, CEO of Eckert & Ziegler, echoed this sentiment, expressing enthusiasm for supporting groundbreaking treatments. Together, we’re paving the way for the future of cancer therapy! Read the media release here