FDA Grants 225Ac-SSO110 Orphan Drug Status in SCLC
225Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment of SCLC.
- The FDA has granted orphan drug designation (ODD) to 225Ac-SSO110 (satoreotide) for the treatment of patients with small cell lung cancer (SCLC).
- A phase 1/2 trial titled SANTANA-225 will evaluate the agent, with an anticipated start in the first quarter of 2025.
- This ODD follows the agent’s recent FDA clearance of its investigational new drug application for the treatment of patients with SCLC or Merkel cell carcinoma (MCC).
The FDA has granted ODD to 225Ac-SSO110 for the treatment of patients with SCLC.
A global, open-label, phase 1/2 trial titled SANTANA-225 plans to evaluate the safety, tolerability, preliminary efficacy, and recommended phase 2 dose of 225Ac-SSO110 in extensive-stage SCLC or MCC treatment. Patients must be on first-line maintenance therapy with checkpoint inhibitors.
The SANTANA-225 trial is expected to begin enrolling patients in the first quarter of 2025.
Small cell lung cancer: © Констянтин Батыльчук- stock.adobe.com
"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," said Manfred Rüdiger, chief executive officer at Ariceum Therapeutics, in a press release.
225Ac-SSO110 is a somatostatin receptor 2 (SST2) antagonist being developed for the potential treatment of patients with SCLC and MCC. Investigators are evaluating the agent with 68Ga-SSO120 as part of a theranostic approach for targeted radionuclide therapy.
In January 2025, the FDA cleared 225Ac-SSO110’s investigational new drug application for the treatment of patients with SCLC and MCC.2
Preclinical data from October 2024 showed the potential of 225Ac-satoreotide to outperform SSTR2 targeting agonists. 225Ac-satoreotide led to a high frequency of complete durable responses and 100% survival compared with DOTA-TATE-based agonists in SCLC and pancreatic cancer.3
In addition to outperforming DOTA-TATE in antitumor efficacy at lower doses, 225Ac-SSO110 was well tolerated across all dose levels, supporting the advanced clinical development of the agent in SCLC, MCC, as well as in other aggressive cancers.
REFERENCES:
U.S. FDA grants orphan drug designation to Ariceum Therapeutics' proprietary radiopharmaceutical cancer therapy. News release. Ariceum Therapeutics. February 6, 2025. Accessed February 6, 2025. https://tinyurl.com/3u7uau6s
FDA clears Ariceum Therapeutics' 225Ac-satoreotide phase I/II clinical study in patients with small cell lung cancer or merkel cell carcinoma. News release. Ariceum Therapeutics. January 14, 2025. Accessed January 15, 2025. https://tinyurl.com/yeymj6u2
Ariceum Therapeutics presents outstanding data on its first-in-class radiopharmaceutical drug 225Ac-satoreotide at the european association of nuclear medicine 2024. News release. Ariceum Therapeutics. October 22, 2024. Accessed February 6, 2025. https://tinyurl.com/mzvy7795
FDA Clears 225Ac-SSO110 for Phase 1/2 SCLC and Merkel Cell Carcinoma Trial
January 16th 2025The FDA has approved the investigational new drug application of 225Ac-SSO110, allowing for the start of a phase 1/2 trial in patients with extensive-stage small cell lung cancer and Merkel cell carcinoma.
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