FDA Approves Ariceum's 225Ac-Satoreotide Trial for Lung and Skin Cancer

BERLIN, Germany I January 14, 2025 I Ariceum Therapeutics, a biotechnology company specializing in radiopharmaceuticals for challenging cancer types, has announced approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application. This approval permits the commencement of a Phase I/II clinical trial, named 'SANTANA-225', to evaluate their novel radiolabeled peptide, 225 Ac-SSO110, in patients with small cell lung cancer (SCLC) or Merkel Cell Carcinoma (MCC).

The SANTANA-225 trial is designed as a global, open-label study to explore the safety, tolerability, and preliminary efficacy of 225 Ac-SSO110. Additionally, the trial aims to establish the recommended Phase II dosage for patients suffering from extensive-stage SCLC or MCC who are currently receiving first-line maintenance therapy with checkpoint inhibitors. Ariceum is actively collaborating with partners and clinical sites across the US and internationally to initiate patient recruitment in the first quarter of 2025.

Germo Gericke, the Chief Medical Officer at Ariceum Therapeutics, emphasized the significance of this development for both the company and the broader field of targeted radionuclide cancer treatments. He highlighted that 225 Ac-SSO110 is the first antagonist of the somatostatin receptor 2 (SSTR2), labeled with Actinium-225, to be tested in human trials. This compound combines the benefits of a long half-life alpha particle emitter with a tracer that has extended tumor retention. He expressed optimism about its potential, given the promising clinical results previously obtained with 177 Lu-SSO110 and encouraging pre-clinical data for 225 Ac-SSO110 in treating cancers that are typically difficult to manage.

Ariceum is developing 225 Ac-SSO110 alongside its companion patient selection tracer, 68 Ga-SSO120, constituting a 'theranostic pair' aimed at targeting radionuclide treatment across various indications expressing SSTR2, such as SCLC, MCC, and other aggressive cancer forms. The company has recently expanded its global supply agreements to secure medical radionuclides Actinium-225 and Lutetium-177, which are essential for radiolabeling SSO110.

Ariceum Therapeutics, a private entity in its clinical stage, focuses on the diagnosis and precise treatment of neuroendocrine and other hard-to-treat cancers. The company's name, Ariceum, is an anagram of 'Marie Curie', honoring her groundbreaking work in discovering radium and polonium, which has been instrumental in advancing cancer treatment initiatives.

The company's leading candidate, SSO110, also known as "satoreotide", is labeled with Lutetium-177 or Actinium-225 and serves as an antagonist for the somatostatin type 2 receptor (SSTR2). This receptor is overexpressed in highly aggressive neuroendocrine tumors, such as SCLC and MCC, which often have limited treatment options and poor prognoses. Satoreotide is being developed as a theranostic pair to aid in the combined diagnosis and targeted radionuclide treatment of these tumors. In addition, Ariceum is working on a radiolabeled PARP-inhibitor, ATT001, currently undergoing Phase 1 clinical trials under the name CITADEL-123. ATT001 was acquired following the completion of Ariceum's acquisition of Theragnostics Ltd in June 2023.

Founded in 2021, Ariceum acquired rights to satoreotide from Ipsen, which remains a shareholder. The company is headquartered in Berlin, with operations in Germany, Switzerland, Australia, the UK, and the US. Ariceum is led by a team with substantial expertise and is backed by specialist investors such as EQT Life Sciences, HealthCap, Pureos Bioventures, Andera Partners, and Earlybird Venture Capital.