Ariceum Therapeutics doses first patient with its first-in-class targeted radiopharmaceutical drug satoreotide in its Phase Ib study in small cell lung cancer

• Ariceum develops satoreotide its first and best-in-class somatostatin receptor 2 antagonist in extensive stage small cell lung cancer
• Phase Ib study design will be presented at the European Association of Nuclear Medicine Congress 2023 (EANM 2023) in Vienna, Austria on 10^th September 2023

BERLIN, Sept. 7, 2023 /PRNewswire/ -- Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, is pleased to announce that the first patient has been dosed with its first-in-class lead molecule, satoreotide, targeting extensive stage small cell lung cancer (ES-SCLC), at the Murdoch University Health Center in Perth, Australia.

Ariceum has successfully initiated its multicentre, open label Phase Ib study which will investigate the safety and tolerability of the 'theranostic pair' of somatostatin receptor antagonist ⁶⁸Ga-Satoreotide Trizoxetan (SSO120) and ¹⁷⁷Lu-satoreotide tetraxetan (SSO110) in patients with ES-SCLC. The main objective of the study is to establish a recommended Phase 2 dose and schedule.

'Theranostics' is the approach of using two paired drugs – the first, a diagnostic agent to identify cells which exhibit a particular biomarker; and the second, a therapeutic drug, to act on those cells. Both the diagnostic agent and therapeutic drug contain Ariceum's proprietary peptide satoreotide, a first-in-class and best-in-class antagonist of the somatostatin receptor 2 (SST2), a cell surface protein often overexpressed in certain cancers including small cell lung cancer (SCLC).

The study, entitled LuSato-1 study, includes patients with ES-SCLC who will each receive an infusion containing the diagnostic imaging agent, somatostatin receptor antagonist before undergoing a positron emission tomography (PET) scan. This will determine if a patient's tumours express the SST2. Patients identified with confirmed SST2 expression will receive escalating doses of satoreotide, in addition to the immunotherapy atezolizumab, a PD-L1 checkpoint inhibitor, during the maintenance phase of their treatment until a recommended phase 2 dose can be defined. Additional patients may be enrolled in an expansion cohort. Further details on the study can be found on Australian Clinical Trials, under identifier Ariceum SSO11O-01.

Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: "The initiation of this Phase Ib study is an important milestone reached by the Company in close collaboration with our partners in Australia and Europe. We believe that our lead targeted systemic radiopharmaceutical product satoreotide has the potential to demonstrate positive results in patients with extensive stage small cell lung cancer. Theranostics holds great hope as a highly targeted form of cancer therapy, using a 'search and destroy' approach to seek out tumours while sparing healthy tissue." 

Germo Gericke, Chief Medical Officer of Ariceum Therapeutics, said: "Although immune checkpoint blockade has improved the treatment of ES-SCLC, disease recurrence often occurs early in the maintenance phase. Adding targeted radiotherapy with satoreotide to immune checkpoint blockade in the maintenance setting holds the promise to improve the therapeutic effect of the maintenance therapy." 

An Abstract on the LuSato-1 study will be presented at the  European Association of Nuclear Medicine Congress 2023 (EANM 2023) in Vienna, Austria, on 10^th September 2023. Presentation details below.

Abstract OP-230
Top Rated Oral Presentations (TROP) Session: Oncology & Theranostics Committee
Session: 606 - Neuroendocrine Tumours Treatment
Abstract title:  A phase I theranostic study evaluating the safety and tolerability of ¹⁷⁷Lu-satoreotide tetraxetan with ⁶⁸Ga-satoreotide trizoxetan companion imaging in participants with extensive-stage small-cell lung cancer (ES-SCLC) on atezolizumab maintenance therapy
Authors: L. Emmett, J. Cardaci, K. O'Byrne, S. Arulananda, A. Prawira, B. Pais, M. Crumbaker, N. Lenzo
Date & Time: 10 September, 4:45-6:15pm CEST

Notes to Editors

About Ariceum Therapeutics

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 (SST2) receptor which is overexpressed in neuroendocrine tumours (NETs) and some aggressive cancers such as small cell lung cancer (SCLC), 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 Therapeutics, launched in 2021, acquired all rights from Ipsen. Ipsen remains a shareholder in the Company. Ariceum is headquartered in Berlin, with operations in Germany, Australia, United Kingdom, United States of America and Switzerland and 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 www.ariceum-therapeutics.com