Theragnostics Ltd.

Ariceum's 225Ac-Satoreotide Receives FDA Orphan Drug Designation and IND Clearance for SCLC and Merkel Cell Carcinoma

4 months ago

• The FDA granted Orphan Drug Designation to Ariceum Therapeutics' 225Ac-satoreotide for small cell lung cancer (SCLC), offering development incentives and potential market exclusivity. • Ariceum's IND application for 225Ac-SSO110 was cleared by the FDA, enabling a Phase I/II trial for SCLC and Merkel Cell Carcinoma (MCC) patients. • The SANTANA-225 trial, set to begin in Q1 2025, will assess the safety, tolerability, and preliminary efficacy of 225Ac-SSO110 in patients with advanced SCLC or MCC. • Preclinical data showed 225Ac-satoreotide's potential to outperform SSTR2 targeting agonists, demonstrating complete responses and 100% survival in models of aggressive cancers.

Ariceum Therapeutics Presents Promising Data on 225Ac-Satoreotide at EANM 2024

7 months ago

Ariceum Therapeutics showcased significant findings on 225Ac-Satoreotide, a novel radiopharmaceutical, at the European Association of Nuclear Medicine 2024 conference. The drug demonstrated superior anti-tumour efficacy and pharmacokinetic profile compared to DOTA-TATE, marking a potential breakthrough in treating SSTR2-positive cancers.