Archeus Technologies Receives FDA Clearance for Investigational Prostate Cancer Therapy ART-101
Saturday, June 21, 2025
Archeus Technologies, a company focused on developing radiopharmaceutical treatments for cancer, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for ART-101. This authorisation allows the company to begin a Phase 1 clinical trial of ART-101 in men with metastatic castration-resistant prostate cancer (mCRPC), expected to start later in the year.
ART-101 is a novel small molecule therapy designed to target prostate-specific membrane antigen (PSMA), a receptor commonly found in prostate cancer cells. It was discovered and developed by Dr Reinier Hernandez, an assistant professor at the University of Wisconsin–Madison, with support from the Wisconsin Alumni Research Foundation.
Preclinical studies have shown that ART-101 may offer advantages over currently approved PSMA-targeting therapies, including stronger tumour uptake and retention, and reduced accumulation in healthy tissues such as salivary glands. Archeus aims to develop ART-101 as a theranostic radiopharmaceutical, capable of delivering alpha particle-emitting isotopes with improved safety and effectiveness.
This IND clearance marks a significant step forward in the company’s efforts to introduce a range of radiopharmaceutical treatments for challenging cancers. ART-101 is among several candidates in Archeus’ pipeline set to enter clinical testing in the near future.
In addition to ART-101, the company previously received IND clearance in October 2024 for its lead therapy ARC-706 and its companion diagnostic ARC-166. Both are being developed as a theranostic pair for use in combination with established immunotherapies. Preclinical findings suggest this approach may generate long-lasting immune responses and potentially curative outcomes in cancers that are typically resistant to current treatments.
Source: businesswire.com
