GPC1

JANESVILLE, Wis., Sept. 18, 2024 /PRNewswire/ -- 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. Continue Reading SHINE will supply Ilumira, its n.c.a. Lu-177 chloride, for use in GlyTherix's clinical trials focused on innovative treatments for aggressive and invasive cancers. 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. SHINE's Ilumira is produced in the company's Cassiopeia facility in Janesville, Wisconsin - the largest of its kind in North America. 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 [email protected] SHINE: [email protected] SOURCE SHINE Technologies, LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

A research team has developed a theranostics approach to both diagnose and treat certain pancreatic cancer cases. They radioactively labeled a monoclonal antibody targeting glypican-1, which is highly expressed in pancreatic cancer, then administered it to disease model mice. One label, 89Zr, showed high uptake in tumors, which would allow early detection of pancreatic cancer with PET scans. Another label, 211At, was used with alpha therapy to significantly slow tumor growth. Pancreatic ductal adenocarcinoma (PDAC) is one of the deadliest cancers worldwide, with a 5-year survival rate of less than 10%. Many PDAC tumors in early stage go undetected because they are not found using conventional imaging methods, including fluorodeoxyglucose positron emission tomography (PET) scans. To more efficiently combat this pancreatic cancer, a team led by researchers at Osaka University is combining diagnostic and therapeutic procedures into a single integrated process: 'theranostics'. In an article recently published in Journal of Nuclear Medicine, the team has developed a 'radio-theranostics' strategy that uses a new radioactive antibody to target glypican-1 (GPC1), a protein highly expressed in PDAC tumors. Theranostics, particularly radio-theranostics, has been receiving increasing attention because, by radio-labeling the compounds used to target certain molecules in cancer cells, diagnosis and treatment can be carried out sequentially. "We decided to target GPC1 because it is overexpressed in PDAC but is only present in low levels in normal tissues," explains Tadashi Watabe, lead author of the study. The team used a monoclonal antibody (mAb), an antibody designed to target a certain molecule, to target GPC1. The mAb could be labeled with radioactive zirconium (89Zr) or radioactive astatine (211At). They worked with a xenograft mouse model, which involved human pancreatic cancer cells being injected into a mouse that developed into a full tumor that could be experimentally treated and monitored. These mice were intravenously administered 89Zr-labeled GPC1 mAb. They were also given 211At-labeled GPC1 mAb to examine the antitumor effects. "We monitored 89Zr-GPC1 mAb internalization over seven days with PET scanning," explains Kazuya Kabayama, the second author of the article. "There was strong uptake of the mAb into the tumors, suggesting that this method could support tumor visualization. We confirmed that this was mediated by its binding to GPC1, as the xenograft model that had GPC1 expression knocked out showed significantly less uptake." The researchers next tested this model with alpha therapy using 211At-GPC1 mAb, a method that could support radioactive label-based delivery of a therapeutic molecule to its target. Administration of 211At-GPC1 mAb resulted in DNA double-strand break induction in the cancer cells, as well as significantly reduced tumor growth. Control experiments showed that these antitumor effects did not occur when mAb internalization was blocked. Additionally, non-radiolabeled GPC1 mAb did not induce these effects. "Both radiolabeled versions of the GPC1 mAb we examined showed promising results in PDAC," says Watabe. "89Zr-GPC1 mAb showed high tumoral uptake, while 211At-GPC1 mAb could be used for targeted alpha therapy to support suppression of PDAC tumor growth." These highly impactful data demonstrate the potential for using a theranostics approach in PDAC, a disease in dire need of new diagnostic and therapeutic options. In the future, this could lead to early detection of PDAC with PET imaging and systemic treatment with alpha therapy.

Phalguni Deswal @Phalguni_GD Biosygen also has two other T-cell therapies in Phase I/II clinical development. Image Credit: Juan Gaertner / Shutterstock. Biosyngen received an all-clear from the US Food and Drug Administration (FDA) on the Investigational New Drug (IND) application for the BRL03 to start Phase I/II trials. BRL03 is a T-cell receptor (TCR) therapy that isolates a patient’s T-cells and then genetically modifies them to target specific cell antigens. These modified T-cells are then infused back into the patient. BRL03 would be investigated to treat lung, gastric, and other advanced solid tumours. Recommended Reports Reports LOA and PTSR Model - Gene Therapy to Target KK-LC-1 for Oncology GlobalData Reports LOA and PTSR Model - Monoclonal Antibody Conjugate to Target GPC1 for Oncology GlobalData View all BRL03 was developed using Biosyngen’s drug discovery platform, IDENTIFIER. The IDENTIFIER platform utilises TCR and tumour proteome databases to discover, screen and optimise therapies. Biosyngen also uses its MSE-T technology platform to decrease T-cell depletion, leading to sustained tumour-suppressing effects. Cell therapies are a growing area of interest in the immuno-oncology (IO) field. As per GlobalData, the IO sector was worth approximately $48bn in 2022 . GlobalData is the parent company of Pharmaceutical Technology . The Singapore-based company also has other T-cell therapies in its pipeline. BRG01 is an Epstein–Barr virus (EBV) targeted chimeric antigen receptor (CAR) T-cell therapy, which is currently in Phase I/II (NCT05864924) clinical development in the US and China. Phase I of the trial is expected to be completed by the end of 2023. BRG01 is also being investigated for the treatment of EBV-positive lymphoma. Biosyngen is also developing a tumour infiltrating lymphocyte (TIL) therapy, BST02. As part of the TIL therapy, the patient’s own tumour-infiltrating lymphocytes, a type of T-cell, are isolated, and then the best-targeted lymphocytes are selected. These lymphocytes are then expanded and infused back into the patient. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy