Ariceum Therapeutics GmbH

225Ac-satoreotide is a first-in-class Actinium-labelled somatostatin receptor 2 antagonist targeting extensive-stage Small Cell Lung Cancer or Merkel Cell Carcinoma Orphan Drug Designation follows outstanding preclinical data and FDA IND clearance Phase I/II human trials set to commence in Q1 2025 as a 'theranostic' targeted radionuclide treatment BERLIN, Feb. 6, 2025 /PRNewswire/ -- Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to 225Ac-SSO110 (satoreotide) for the treatment of patients with Small Cell Lung Cancer (SCLC). SCLC is a deadly condition that represents a significant unmet medical need due to the limited number of treatment options available to patients with this aggressive form of cancer. Two-thirds of SCLC patients are diagnosed at an advanced stage where the disease has already spread significantly, resulting in a poor prognosis and a 5-10% overall five-year survival rate. Ariceum will commence Phase I/II human clinical development of 225Ac-satoreotide under the trial name, SANTANA-225 in Q1 2025. Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: "Receiving ODD for 225Ac-satoreotide is a recognition of its potential as a treatment option for patients with SCLC and an important regulatory milestone for Ariceum. The FDA's ODD will support our objective to accelerate the development of 225Ac-satoreotide through human trials to provide a potentially life-saving therapy to patients with limited alternatives." The FDA provides ODD to drugs and biologics that demonstrate potential for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people in the U.S. The designation provides development and commercial incentives for designated compounds and medicines, including eligibility for seven years of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, and an exemption from FDA user fees. In October 2024, Ariceum published outstanding preclinical data demonstrating the significant potential of 225Ac-satoreotide to outperform SSTR2 targeting agonists. 225Ac-satoreotide showed a high frequency of complete durable responses and 100% survival supporting advanced clinical development in SCLC, MCC, and other aggressive cancers. 225Ac-satoreotide in combination with its companion patient selection tracer 68Ga-SSO120 is being developed as a 'theranostic pair' for the combined diagnosis and targeted radionuclide treatment of multiple indications expressing SSTR2, such as SCLC, MCC, and other aggressive, hard-to-treat cancers. About Ariceum Therapeutics Ariceum Therapeutics 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 candidate, SSO110 ("satoreotide") labelled with Lutetium-177 (177Lu) and Actinium-255 (255Ac) is an antagonist of the somatostatin type 2 (SSTR2) receptor which is overexpressed in aggressive neuroendocrine tumours (NETs) such as small cell lung cancer (SCLC) or Merkel Cell Carcinoma (MCC), all of which have limited 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, which has remained a shareholder of the Company. Ariceum is headquartered in Berlin, with operations in Germany, Switzerland, Australia, the United Kingdom, and the United States. 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 . 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. Novo Nordisk is investing DKK 120 million ($16.5 million) into Denmark’s new manufacturing learning center called Campus Kalundborg, which is envisioned to grow the local student population to 1,500 by 2030. The Novo Nordisk Foundation is also investing DKK 202 million ($27.9 million) for teaching and training resources until 2031. In total, more than DKK 320 million ($44 million) is being invested. Telix Pharmaceuticals is acquiring a Californian research facility and its employees, a few early clinical-stage assets and biologics technology from antibody engineering company ImaginAb, according to a Monday release. No financial details were disclosed. Telix is also taking control of sales and marketing of its bone infection imaging asset, dubbed Scintimun, which it previously outlicensed to Curium Pharma, the company said Monday. Telix plans on researching Scintimun in combination with its Phase 2 bone marrow stem cell asset, called TLX66 (90Y-besilesomab). Curium will still manufacture Scintimun for Telix. Scintimun was EMA approved in January 2010. Charles River Laboratories is using Akron Bio’s line of liquid cytokines in its cell therapy manufacturing platform, the companies said Thursday. Cytiva and Cellular Origins are partnering to combine their cell therapy manufacturing platforms, according to a Thursday release. Isotope producer Nusano and Atley Solutions are partnering to establish a commercial supply chain for the radioisotope Astatine-211, the companies announced Thursday. ReciBioPharm, owned by CDMO Recipharm, has secured a three-year grant from the Bill & Melinda Gates Foundation to distribute its manufacturing tech to low and middle-income countries, the company said Monday. The technology is used to scale up manufacturing of RNA-based medicines. Emergent BioSolutions has received $16.7 million from the Center for the Biomedical Advanced Research and Development Authority (BARDA) to further develop and test its Zaire Ebola virus drug called Ebanga. This is its second contract option from BARDA; the original 10-year contract for Ebanga was signed in July 2023. Diagnostic solutions company Sysmex America is planning to build a new manufacturing and distribution facility in São José dos Pinhais, Brazil, the company said Wednesday. Construction is expected to start in the second quarter of 2025. Cell therapy CDMO BioCentriq is partnering with tech consultancy firm Orchestra Life Sciences, which will provide its manufacturing platform for BioCentriq’s new 60,000-square-foot Princeton, NJ facility. Orchestra will also help design the factory, according to a Tuesday release. CDMO Kindeva Drug Delivery and RNA vaccine tech company Emervax are collaborating to develop a new vaccine delivery method. Kindeva has given Emervax access to its microneedle vaccine patch, which Emervax will use with its RNA tech platform, according to a Jan. 9 press release. Alcami Corporation CEO Bill Humphries has stepped down and will be replaced by Patrick Walsh who will serve as interim CEO, the company said Monday. Walsh has previously acted as CEO of Alcami twice and has been chairman of the board for the past four years. International Isotopes is expanding its footprint by purchasing a 1.77-acre plot of land to build a 50,000-square-foot factory. Further, the company is leasing a new 8,600-square-foot building. ITM Isotope Technologies Munich is supplying the radioisotope Actinium-225 to Ariceum Therapeutics for its radiopharma pipeline, including its lead asset called satoreotide which is being investigated for certain cancers, according to the Monday release. Inhaler drugmaker Iconovo and Lonza are partnering to develop a spray-dried formula for Iconovo’s nasal device dubbed ICOone Nasal. Lonza will develop the formulation at its Bend, OR, factory, according to the Monday release.

BERLIN, Germany I January 14, 2025 I Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announced that the US Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to commence a Phase I/II clinical trial (‘SANTANA-225’) of its proprietary radiolabelled peptide, 225 Ac-SSO110, in patients with small cell lung cancer (SCLC) or Merkel Cell Carcinoma (MCC). The SANTANA-225 trial is a global, open-label Phase I/II study, that will assess the safety, tolerability, preliminary efficacy and recommended Phase II dose of 225 Ac-SSO110 in patients with extensive-stage SCLC or MCC who are on first-line maintenance therapy with checkpoint inhibitors. Ariceum is working with its partners and clinical sites in the US and other countries to commence recruitment of patients in Q1 2025. Germo Gericke, Chief Medical Officer at Ariceum Therapeutics, said: “This is an important milestone, not only for Ariceum but for the whole field of targeted radionuclide cancer treatments. 225 Ac-SSO110 is the first somatostatin receptor 2 (SSTR2) antagonist labelled with Actinium-225 to undergo human trials, providing the optimum combination of a long half-life α particle emitter with a long tumour retention tracer. Based on encouraging clinical data with 177 Lu-SSO110 and very promising pre-clinical data of 225 Ac-SSO110, we are very optimistic about the potential for patients with difficult to treat cancers.” 225 Ac-SSO110 is being developed together with its companion patient selection tracer 68 Ga-SSO120 as a ‘theranostic pair’ targeted radionuclide treatment of multiple indications expressing SSTR2, such as SCLC, MCC, and other aggressive cancers.  Ariceum has recently expanded its global supply agreements for the medical radionuclides Actinium-225 ( 225 Ac) and Lutetium-177 ( 177 Lu), which will be used to radiolabel SSO110. About Ariceum Therapeutics Ariceum Therapeutics 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 candidate, SSO110 (“satoreotide”) labelled with Lutetium-177 ( 177 Lu) and Actinium-255 ( 255 Ac) is an antagonist of the somatostatin type 2 (SSTR2) receptor which is overexpressed in aggressive neuroendocrine tumours (NETs) such as small cell lung cancer (SCLC) or Merkel Cell Carcinoma (MCC), all of which have limited 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, which has remained a shareholder of the Company. Ariceum is headquartered in Berlin, with operations in Germany, Switzerland, Australia, the United Kingdom, and the United States. 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 www.ariceum-therapeutics.com . SOURCE: Ariceum Therapeutics