Ariceum Therapeutics GmbH

iStock, Ihor Reshetniak Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies. The emergence of actinium-225 as the next big thing in radiopharmaceuticals is fueling a race to add and access manufacturing capacity for the isotope. With leading drugmakers moving candidates deeper into clinical testing, actinium-225 suppliers have invested to increase capacity and struck a string of deals to meet their customers’ demands for the alpha emitter. Lutetium-177, a beta-emitting isotope, has defined the growing radiopharmaceutical industry since the FDA approved Novartis’ Lutathera in 2018. Novartis uses the same isotope in Pluvicto, a radioligand therapy that the FDA approved in 2022. Combined, Lutathera and Pluvicto, both cancer drugs, generated sales of $2.8 billion for Novartis in 2025. Drugmakers are continuing to invest in cancer medicines based on lutetium-177. Novartis is run multiple trials to build on its leadership, ITM filed for approval in November and companies including Eli Lilly are moving assets through the clinic. At the same time, the sector’s focus is expanding beyond lutetium-177, with companies studying a growing set of isotopes led by actinium-225 in pursuit of a competitive advantage. Now, suppliers of the alpha emitter are ramping up. Adding Actinium-225 Capacity Compared to lutetium-177, actinium-225 emits more energy over a smaller area. Therapies based on it could be more efficacious, as they are thought to cause more double-strand DNA breaks in cancer cells and result in less damage to healthy tissues. Novartis discussed its expansion into alpha emitters, and actinium in particular, at an R&D day in 2019, but it took a few more years for the sector to ignite. From October 2023 to March 2024, AstraZeneca, Bristol Myers Squibb and Lilly each struck deals to buy biotechs developing drug candidates based on actinium-225. The proliferation of programs has strained the supply chain, leading BMS’ RayzeBio to pause a Phase 3 trial over a shortage of actinium-225 in 2024. Manufacturing Surge in Radiopharmaceutical R&D Puts Pressure on Unique Supply Chain The industry’s ability to generate a return on billions of dollars of investment rests on a heavily regulated supply chain defined by time-pressured logistics. November 18, 2025 · 4 min read · Nick Paul Taylor Read more Oak Ridge National Laboratory (ORNL) has been the main supplier of actinium-225 for almost 30 years. The R&D center, which is funded by the Department of Energy (DOE), makes the isotope via decay of thorium-229 left over from nuclear programs in the 1940s and 1950s. ORNL has increased shipments, but the growth in demand has outpaced its ability to boost output. Multiple groups are working to increase supply. TerraPower Isotopes is increasing access to actinium-225 generated through natural decay by working with Isotek to recover the thorium-229 from uranium-233 stockpiles managed by the DOE. Overseen by the DOE, ORNL and two other national laboratories have used accelerator beam facilities to make actinium-225 from thorium-232. However, material generated in that process is contaminated with actinium-227, leading to the development of alternative approaches such as cyclotrons and linear accelerators. NorthStar CEO Frank Scholz told BioSpace that considerations related to yield, reliability and scalability informed his company’s decision to use electron accelerator–based technology to make actinium-225. Scholz said NorthStar selected the technology after calculating it would need to buy 10 to 15 cyclotrons, depending on the model, to meet its supply needs. “That would mean a significant amount of [capital expenditure] and mean using multiple machines that could fail and need to be maintained,” Scholz said. “The decision goes beyond the pure technical aspect, which we value, and is ultimately a holistic business case.” NorthStar’s actinium-225 is made without the addition of stable elements, resulting in a more potent product known as a non-carrier-added isotope. NorthStar recently claimed to be the first to produce commercial-scale non-carrier-added actinium-225 using electron accelerator technology. BWXT Medical makes non-carrier-added actinium-225 at TRIUMF, Canada’s particle accelerator center. Niowave uses a superconducting electron linear accelerator. Eckert & Ziegler use a cyclotron-based method. Drugmakers Secure Supply The investments in capacity reflect industry demand for actinium-225. AstraZeneca struck a 10-year supply agreement with Niowave in December. The deal, which extended an earlier agreement, secured AstraZeneca a source of actinium-225 for use in drug candidates it acquired in its $2.4 billion Fusion Pharmaceuticals buyout in 2024. Fusion partnered with BWXT Medical to access the isotope in 2023. Bayer has entered into a string of actinium-225 supply agreements in recent years, agreeing to source the isotope from BWXT , Ionetix , NorthStar and PanTera between 2022 and 2024. Cellectar Biosciences diversified its supply chain by striking deals to access the isotope from NorthStar , ITM , Nusano and Ionetix in 2024 and 2025. Point Biopharma, which Eli Lilly bought for $1.4 billion, partnered with Ionetix to source actinium-225 in 2021. Lilly invested in Ionetix in 2024. Ariceum Therapeutics penned a deal in 2025 for actinium-225 from ITM’s joint venture with Canadian Nuclear Laboratories. Eckert & Ziegler has inked a series of deals, agreeing to supply actinium-225 to Actinium Pharmaceuticals , GlyTherix and SK Biopharmaceuticals . Investments in drug candidates based on other isotopes indicate the need for manufacturing capabilities to keep evolving. Nucleus RadioPharma CEO Steve Hahn told BioSpace that copper-67 and astatine-211 are isotopes that are not made in sufficient quantities. The isotopes are part of an increasingly diverse pipeline. Justin Butler, a partner at Eclipse Ventures, told BioSpace he anticipates there will be drug candidates not only involving lutetium and actinium, but also lead and copper isotopes. “We need to have the capabilities to be able to work with all of those if this industry is really going to become as big as we think it can be.”

HAMILTON, ON, Nov. 12, 2025 /PRNewswire/ -- AtomVie Global Radiopharma (AtomVie), a leading radiopharmaceutical CDMO, announced that it has successfully supplied the first dose of Ariceum Therapeutics' (Ariceum) 225Ac-SSO110, a potentially first- and best-in-class Actinium-225-labelled antagonist of the somatostatin type 2 receptor (SSTR2), being evaluated in Ariceum's Phase 1/2 clinical trial (SANTANA-225) for the treatment of extensive-stage small cell lung cancer (SCLC) and Merkel Cell Carcinoma (MCC). Continue Reading AtomVie Global Radiopharma Supplies the First Patient Dose of 225Ac-SSO110 for Ariceum Therapeutics’ Phase 1/2 SANTANA-225 Clinical Trial With this partnership, AtomVie is leveraging its state-of-the-art cGMP facilities and deep technical expertise to enable the robust and reliable manufacturing of 225Ac-SSO110. This collaboration secures a consistent supply and uncompromising quality of 225Ac-SSO110 to support the SANTANA-225 study. "We are honored to partner with Ariceum to deliver the critical supply of 225Ac-SSO110 for the SANTANA-225 clinical trial. Our mission of transforming patients' lives with high quality radiopharmaceuticals drives every step of our work, and we are proud to contribute to bringing promising therapies in oncology closer to patients." said Bruno Paquin, CEO of AtomVie. "Dosing the first patient in our SANTANA-225 clinical trial marks a significant milestone for Ariceum," said Manuel Sturzbecher-Höhne, Chief Technology Officer of Ariceum Therapeutics. "We are proud to partner with AtomVie on the manufacturing of 225Ac-SSO110. Their proven GMP expertise and unwavering commitment to quality give us confidence as we advance 225Ac-SSO110 through clinical development, and deliver on our mission to bring transformative therapies to patients facing these aggressive and underserved cancers." About AtomVie Global Radiopharma AtomVie is a global leading CDMO for the GMP manufacturing and worldwide distribution of clinical and commercial radiopharmaceuticals. AtomVie offers the full range of scientific, technical, regulatory, quality and logistics services combined with a specialized infrastructure for the development of radiopharmaceuticals from clinical studies to the commercial markets. AtomVie currently serves international clients conducting clinical studies in over 28 countries worldwide. AtomVie is currently building a new state-of-art purpose-built 72,300 sq ft facility, set to launch at the end of 2025. For more information, please contact Tina Chainani, Business Development Manager Email: [email protected] Or visit our website About Ariceum Therapeutics Ariceum Therapeutics is a clinical-stage oncology company dedicated to redefining the future of care through targeted radiotherapeutics for patients with aggressive and hard-to-treat cancers. The company's lead program, 225Ac-SSO110, a novel antagonist of the somatostatin type 2 receptor (SSTR2) with best-in-class potential, is currently being investigated in the Phase 1/2 SANTANA-225 study as the first maintenance radiotherapy for extensive stage small cell lung cancer (ES-SCLC) and Merkel Cell Carcinoma (MCC) –two diseases with limited options and poor prognosis. Ariceum is also developing a clinical product candidate ATT001, a novel radiolabeled I-123 PARP inhibitor designed to deliver subcellular precision radiotherapy to aggressive solid tumors. Headquartered in Berlin, Ariceum operates across Germany, Switzerland, Australia, the United Kingdom, and the United States. The company is supported by leading global life sciences investors, including EQT Life Sciences, HealthCap, Pureos Bioventures, Andera Partners, and Earlybird Venture Capital. For further information, please contact: Investors Kevin Lui Director, Investor Relations [email protected] Media Genevieve Britton Group Account Director, Public Relations [email protected] Photo - 21% more press release views with Request a Demo

225Ac-SSO110 has received U.S. FDA Orphan Drug Designation Initial safety data from SANTANA-225 in ES-SCLC and MCC expected in 2026 Potential to address a broad range of neuroendocrine cancers Nov. 11, 2025 -- Ariceum Therapeutics (Ariceum), a targeted radiotherapeutics company dedicated to setting new standards in cancer care, today announced that the first patient has been dosed in the SANTANA-225 Phase 1/2 study of 225Ac-SSO110 for the treatment of extensive stage small cell lung cancer (ES-SCLC) and Merkle Cell Carcinoma (MCC). 225Ac-SSO110 is a potentially first- and best-in-class Actinium-225-labelled antagonist of the somatostatin type 2 receptor (SSTR2). SSTR2 is highly overexpressed in neuroendocrine tumors relative to healthy tissue, making it an ideal target for radioligand therapies (RLTs). The SANTANA-225 clinical trial (NCT06939036) is a global, open-label Phase 1/2 study that will assess the safety, tolerability, preliminary efficacy, and recommended Phase 2 dose of 225Ac-SSO110 in patients with ES-SCLC treated with checkpoint inhibitors (CPI) in first-line maintenance therapy or MCC patients treated with CPI in first-line therapy. The trial is expected to enroll approximately 20 patients in the dose escalation phase of the study, followed by expansion cohorts. In February 2025, 225Ac-SSO110 received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of ES-SCLC. “RLTs are redefining precision oncology by enabling targeted delivery of radiation directly to tumor cells while minimizing exposure to healthy tissue,” said Germo Gericke, MD, Chief Medical Officer of Ariceum Therapeutics. “225Ac-SSO110 is the first SSTR2 antagonist RLT in clinical development, designed to deliver higher doses of alpha radiation directly to patients’ tumors while maintaining a favorable safety profile for individuals with neuroendocrine cancers, including ES-SCLC and MCC. Dosing the first patient in the SANTANA-225 trial is a significant step for our lead program and an important milestone towards addressing urgent patient needs in these aggressive cancers. We expect to report initial safety data from the SANTANA-225 trial in 2026, which may support expansion into additional neuroendocrine tumor indications and further validate the differentiated mechanism of action of 225Ac-SSO110.” ES-SCLC is a deadly and aggressive cancer that represents a significant unmet medical need due to the limited number of treatment options available to patients. Two-thirds of SCLC patients are diagnosed at an advanced stage where the disease has already metastasized, resulting in a poor prognosis and a 5-10% five-year survival rate. MCC is a rare and aggressive type of skin cancer with limited treatment options that also has low survival rates in patients who do not respond to first-line CPI therapy. Both ES-SCLC and MCC are neuroendocrine tumors that frequently express SSTR2, making them compelling initial indications for SSTR2-targeted therapy. 225Ac-SSO110 is the first SSTR2-targeting antagonist radiolabeled with Actinium-225 to undergo human trials in combination with CPI for these neuroendocrine tumor indications, addressing areas of high unmet need and laying the foundation for potential expansion to other SSTR2-expressing cancers. Ariceum Therapeutics is a clinical-stage oncology company dedicated to redefining the future of care through targeted radiotherapeutics for patients with aggressive and hard-to-treat cancers. The company’s lead program, 225Ac-SSO110, a novel antagonist of the somatostatin type 2 receptor (SSTR2) with best-in-class potential, is currently being investigated in the Phase 1/2 SANTANA-225 study as the first maintenance radiotherapy for extensive stage small cell lung cancer (ES-SCLC) and Merkel Cell Carcinoma (MCC) –two diseases with limited options and poor prognosis. Ariceum is also developing ATT001, a novel radiolabeled I-123 PARP inhibitor designed to deliver subcellular precision radiotherapy to aggressive solid tumors. Headquartered in Berlin, Ariceum operates across Germany, Switzerland, Australia, the United Kingdom, and the United States. The company is supported by leading global life sciences investors, including EQT Life Sciences, HealthCap, Pureos Bioventures, Andera Partners, and Earlybird Venture Capital. The content above comes from the network. if any infringement, please contact us to modify.