Ariceum Therapeutics receives the orphanage of the FDA for targeted radionuclide cancer treatment

Ariceum therapeutics (ariceum), a private biotech company that develops radiopharmaceutical products for the diagnosis and treatment of certain cancer to be treated ²²⁵AC-SSO110 (Satoreotide) for the treatment of patients with small cell lung cancer (SCLC).

SCLC is a fatal disease that, due to the limited number of treatment options that are available to patients with this aggressive form of cancer, are significant medical needs. Two thirds of SCLC patients are diagnosed in an advanced stage in which the disease has already spread significantly, which leads to a poor forecast and a survival rate of 5 to 10%. Ariceum begins with phase I/II human clinical development of ²²⁵AC-Satoreotid from the name, Santana-225 in Q1 2025.

Strange for ²²⁵AC-Satoreotide is a detection of its potential as a treatment option for patients with SCLC and an important regulatory milestone for ariceum. The ODD of the FDA will support our goal of accelerating the development of ²²⁵AC-Satoreotide through human studies to offer patients with limited alternatives a potentially life-saving therapy. “

Manfred Rüdigiger, Chief Executive Officer, ariceum therapeutics

The FDA offers medication and biologicals that show the potential for the diagnosis and/or treatment of rare diseases or diseases that affect fewer than 200,000 people in the US Exemption from FDA user fees.

In October 2024, Ariceum released the outstanding preclinical data that showed the significant potential of ²²⁵AC-Satoreotide to exceed SSR2-Targeting agonists. ²²⁵AC-Satoreotide showed a high frequency of complete permanent reactions and 100% survival, which supported the advanced clinical development in SCLC, MCC and other aggressive types of cancer. ²²⁵AC-Satoreotid in combination with its accompanying patient selection-tracer 68GA SSO120 is the “Theranostic Couple” for the combined diagnosis and targeted radion luclide treatment of several indications that express SSD2-