Ariceum Therapeutics GmbH

NorthStar will supply non-carrier added Actinium-225, a radionuclide, for use with Ariceum's first-in-class radiopharmaceutical drug, satoreotide BERLIN and BELOIT, Wis., Dec. 11, 2024 /PRNewswire/ -- Ariceum Therapeutics, a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, and NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, today announced the signing of a supply agreement for the therapeutic medical radioisotope, Actinium-225 (Ac-225). Under the terms of the agreement, NorthStar will provide Ariceum with non-carrier-added (n.c.a.), high purity, Ac-225, a rare and critical isotope that is in high demand, providing Ariceum with an additional clinical source of supply for its evolving pipeline development programs. Ariceum will use NorthStar's Ac-225 to radiolabel its proprietary peptide (SS0110) satoreotide, a first-in-class antagonist of the somatostatin receptor 2 (SSTR2). Satoreotide is being developed as a 'theranostic pair' for the combined diagnosis and targeted radionuclide treatment of multiple indications expressing SSTR2, such as small cell lung cancer (SCLC), pancreatic cancers, Merkel Cell Carcinoma, and other aggressive cancers. Manfred Rüdiger, Chief Executive Officer of Ariceum Therapeutics, commented: "Satoreotide is the first Ac-225 labelled antagonist of the SSTR2 receptor targeting SCLC. The compound is scheduled to enter clinical development in the US as part of a transatlantic trial soon. The compound has demonstrated its potential as a Lutetium-177-labelled version in our ongoing Phase 1b clinical study in end stage-SCLC. Based on NorthStar's industry leadership and commercial expertise in cutting-edge, accelerator-based radioisotope production technology, we believe that they are a reliable partner to meet Ariceum's specific needs. In partnership with NorthStar, we look forward to progressing our clinical studies with Ac-225 and accelerating our future commercialization opportunities as we seek to deliver targeted theranostic treatments for patients." "Ariceum's impressive development portfolio is focused on very aggressive, difficult-to-treat cancers and its early trial results are very exciting," said Frank Scholz, President and Chief Executive Officer of NorthStar. "At NorthStar, our goal is to reduce or eliminate concerns about adequate availability of Ac-225 for clinical trials and patient medicines, which have held back exploration of powerful new pathways to attack these diseases for the millions of patients who today have limited treatment options available. We are proud to use our expertise and capabilities to provide innovative companies like Ariceum with high purity, n.c.a. Ac-225, that will help make potential new treatment therapies a prospect for the benefit of patients." About Ariceum Therapeutics, GmbH Ariceum Therapeutics (Ariceum) is a private, clinical stage radiopharmaceutical company focused on the diagnosis and precision treatment of certain neuroendocrine and other aggressive, hard-to-treat cancers. The name Ariceum is an anagram of 'Marie Curie' whose discovery of radium and polonium have been huge contributions to finding treatments for cancer. Ariceum's lead targeted systemic radiopharmaceutical product, 177Lu-satoreotide tetraxetan ("satoreotide"), is an antagonist of the somatostatin type 2 (SSTR2) receptor which is overexpressed in neuroendocrine tumours (NETs) and some aggressive cancers such as small cell lung cancer (SCLC), or Merkel Cell Carcinoma (MCC), all of which have few treatment options and poor prognosis. Satoreotide is being developed as a 'theranostic pair' for the combined diagnosis and targeted radionuclide treatment of these tumours. Ariceum is also developing a radiolabelled PARP-inhibitor (ATT001), currently in Phase 1 clinical development under the trial name CITADEL-123. ATT001 was part of the acquisition of Theragnostics Ltd which was closed in June 2023. Ariceum Therapeutics, launched in 2021, acquired all rights to satoreotide from Ipsen. Ipsen remains a shareholder in the Company. Ariceum is headquartered in Berlin, with operations in Germany, Switzerland, Australia, United Kingdom and United States of America and with activities currently across the globe. Ariceum is led by a highly experienced management team and supported by specialist investors including EQT Life Sciences (formerly LSP), HealthCap, Pureos Bioventures, Andera Partners and Earlybird Venture Capital. For further information, please visit . About NorthStar Medical Radioisotopes, LLC (NorthStar) NorthStar Medical Radioisotopes is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar's expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies. NorthStar routinely produces copper-67 (Cu-67) and is poised to be the first commercial-scale producer of non-carrier-added (n.c.a.) actinium-225 (Ac-225). The Company's Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs. For more information about NorthStar's comprehensive portfolio and patient-focused services, visit: . SOURCE Ariceum Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. National Resilience is replacing its CEO effective immediately with COO William Marth, who will take over from Rahul Singhvi. Marth previously served as CEO of Curia Global, known then as AMRI, as well as CEO of Teva Pharmaceutical’s US division. Moderna has opened its new mRNA manufacturing facility in Australia within the campus of Monash University. The new site will be able to make 100 million vaccine doses a year, and the first dose is anticipated to be produced next year. Around 140 new “direct” jobs will be created at the site. Reckitt Benckiser is pouring £155 million ($200 million) into a new facility in Wilson, NC, to make its over-the-counter flu and cold drug products, the company said Tuesday. This will be Reckitt’s largest OTC manufacturing site in the US and will create 300 new jobs. CDMO Cambrex is partnering with Eli Lilly’s biotech innovative arm, dubbed Lilly Catalyze360-ExploR&D, to offer its services to Lilly’s biotech partners, according to a Thursday release. Agenus has revealed its planning to make layoffs as a part of its wider plan to reduce costs, the company said Thursday. The company said Monday it is restructuring its manufacturing sites to become a biologics CDMO. Nature’s Toolbox has secured $15 million from JP Morgan to fund the development of its manufacturing platforms to make biomaterials, the company said Wednesday. Altasciences is the manufacturer for several of Metsera’s weight loss candidates, the company said on Nov. 28. The CDMO has produced the biotech’s Phase 1/2 GLP-1 asset, dubbed MET-097i. It is also making two other candidates for Metsera: a long-acting amylin analog (MET-233i) and an oral GLP-1 drug (MET-002). Rallybio is moving its C5 inhibitor into a confirmatory study next year following manufacturing improvements, the company said Monday. After data analysis and changes to the production of the drug, named RLYB116, the study will be completed in the second quarter of 2025. GE Healthcare is gaining full ownership of the radiopharma manufacturer Nihon Medi-Physics by buying Sumitomo Chemical’s 50% stake in the company, according to a Sunday release. The transaction is expected to close early next year. Telix IsoTherapeutics has renewed its supply agreement with clinical-stage radiopharma Plus Therapeutics, according to a Tuesday release. Telix will continue to supply rhenium-186 isotopes for Plus’ lead candidate, obisbemeda, which is being studied for CNS tumours. Eckert & Ziegler is supplying the radiopharma company Ariceum Therapeutics with actinium-225 and lutetium-177 for its lead asset, satoreotide, under study for hard-to-treat cancers. KBI Biopharma will manufacture Alanis Therapeutics’ preclinical antibody that is being investigated for myelodysplastic syndromes and acute myeloid leukemia, according to a Tuesday release. CELLforCURE by SEQENS is partnering with clinical-stage biotech Smart Immune, according to a Tuesday release. The CDMO will make the biotech’s Phase 1/2 asset, SMART101, for acute leukemia or primary immunodeficiencies. NorthX Biologics will make Amarna Therapeutics’ clinical-stage gene therapy called Nimvec AM510, which is being investigated for type 1 diabetes, according to a Tuesday announcement. API manufacturer Antheia will receive $12 million from the US Department of Health and Human Services over two years to manufacture an unnamed pharma ingredient domestically, according to a Tuesday release. Lonza’s ADC company Synaffix has entered a licensing agreement with DNA sequencer Illumina, the companies said Wednesday. Synaffix’s so-called “metal-free clock chemistry” tech will be used by Illumina for its DNA sequencing products. Chemical manufacturer LG Chem is collaborating with microbiology biotech Acies Bio on sustainable commercial production of chemicals in high demand, the companies said Thursday. The UK Health Security Agency has signed a contract with CSL Seqirus to manufacture five million doses of human H5 influenza vaccines for the UK, the agency said Tuesday. The Brazilian research organization Oswaldo Cruz Foundation signed a memorandum of understanding with Belgian companies Quantoom Biosciences and Univercells to boost production of RNA therapeutics in Belgium, according to a Friday release. Gavi, the Vaccine Alliance, is investing $23.4 million to help vaccinate children in Sudan, in partnership with Save the Children and UNICEF, according to a Monday release. The funding will in part be used to improve vaccine storage and cold supply chains. With additional reporting by Katherine Lewin

BERLIN, Dec. 5, 2024 /PRNewswire/ -- Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, and Eckert & Ziegler, one of the world's largest providers of isotopes for medical, scientific and industrial use, today announced the signing of a global supply agreement for the medical radionuclides Actinium-225 (Ac-225) and Lutetium-177 (Lu-177). Following limited global availability, alongside increasing demand for Ac-225, which comes with intricate manufacturing complexities, this collaboration is a significant step forward in accelerating Ariceum's novel targeted radiopharmaceutical pipeline programs. Under the terms of the agreement, Eckert & Ziegler will supply Ariceum with the required quantities of non-carrier-added (n.c.a.) Ac-225 and Lu-177. Both radionuclides will be used to radiolabel Ariceum's proprietary lead radiopharmaceutical drug (SS0110) satoreotide targeting hard-to-treat cancers in clinical studies and subsequent commercial phases. The agreement also includes options for expansion to other drugs as well as the use of additional radionuclides in preparation for future commercialisation activities. Manfred Rüdiger, Chief Executive Officer of Ariceum Therapeutics, said: "This important global supply agreement with Eckert & Ziegler for n.c.a. Ac-225 and Lu-177 will ensure an adequate supply of radionuclide isotopes to conduct our clinical trials. We are looking forward to working with the Eckert & Ziegler team to build a robust supply chain and to reliably deliver targeted theranostic treatments for patients with hard-to-treat cancers. Our lead radiopharmaceutical drug, satoreotide is a first-in-class, antagonist of the somatostatin receptor 2 (SSTR2) labelled with Ac-225 to enter clinical development in small cell lung cancer and in Merkel Cell Carcinoma very soon." Dr. Harald Hasselmann, Chief Executive Officer of Eckert & Ziegler, commented: "In collaborating with Ariceum, we support their mission to develop innovative radiopharmaceuticals for the benefit of patients. Both the production start for Ac-225, announced earlier this week, and the successful European approval of Theralugand®, show that our goal is to sustainably reduce the shortage of high-quality radioisotopes. We aim to foster the progress of novel treatments in clinical trials and beyond, and thus contribute to saving lives." About Ariceum Therapeutics, GmbH Ariceum Therapeutics (Ariceum) is a private, clinical stage radiopharmaceutical company focused on the diagnosis and precision treatment of certain neuroendocrine and other aggressive, hard-to-treat cancers. The name Ariceum is an anagram of 'Marie Curie' whose discovery of radium and polonium have been huge contributions to finding treatments for cancer. Ariceum's lead targeted systemic radiopharmaceutical product, 177Lu-satoreotide tetraxetan ("satoreotide"), is an antagonist of the somatostatin type 2 (SSTR2) receptor which is overexpressed in neuroendocrine tumours (NETs) and some aggressive cancers such as small cell lung cancer (SCLC), or Merkel Cell Carcinoma (MCC), all of which have few treatment options and poor prognosis. Satoreotide is being developed as a 'theranostic pair' for the combined diagnosis and targeted radionuclide treatment of these tumours. Ariceum is also developing a radiolabelled PARP-inhibitor (ATT001), currently in Phase 1 clinical development under the trial name CITADEL-123. ATT001 was part of the acquisition of Theragnostics Ltd which was closed in June 2023. Ariceum Therapeutics, launched in 2021, acquired all rights to Satoreotide from Ipsen. Ipsen remains a shareholder in the Company. Ariceum is headquartered in Berlin, with operations in Germany, Switzerland, Australia, United Kingdom and United States of America and with activities currently across the globe. Ariceum is led by a highly experienced management team and supported by specialist investors including EQT Life Sciences (formerly LSP), HealthCap, Pureos Bioventures, Andera Partners and Earlybird Venture Capital. For further information, please visit . About Eckert & Ziegler SE Eckert & Ziegler SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse. For more information visit : Contributing to saving lives. SOURCE Ariceum Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED