Archeus Technologies has received FDA clearance for its Investigational New Drug (IND) application for ART-101, a novel receptor-based targeting small molecule developed for the imaging and treatment of prostate cancer, the company announced recently.

“This IND clearance marks an important milestone for Archeus as we prepare to initiate the first of multiple clinical trials set to begin this year from our broader portfolio of differentiated radiopharmaceutical assets for difficult-to-treat cancers,” Archeus Technologies CEO Evan Sengbusch, Ph.D., said in a statement.

According to a release, the IND clearance enables Archeus to initiate a Phase 1 clinical trial in men with metastatic castration-resistant prostate cancer (mCRPC). This is expected to start later this year.

The company also received IND clearance in October 2024 for its lead therapeutic candidate, ARC-706 and companion diagnostic, ARC-166.