Archeus Technologies Secures FDA Clearance for ART-101 to Treat Prostate Cancer
Saturday, June 21, 2025
Archeus Technologies has received clearance from the United States Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for ART-101.
ART-101 is a novel receptor-targeting small molecule designed for both imaging and treatment of prostate cancer.
The therapy targets the prostate-specific membrane antigen (PSMA), a well-established biomarker used in several approved imaging and therapeutic agents.
This decision allows the company to begin a Phase 1 clinical trial in men with metastatic castration-resistant prostate cancer (mCRPC), with the study expected to commence later in the year.
Preclinical studies suggest that ART-101 shows improved tumour uptake and retention, while demonstrating lower accumulation in normal tissue and salivary glands when compared to current PSMA-targeted therapies. Archeus is positioning ART-101 as a theranostic radiopharmaceutical, with the potential to deliver alpha-emitting isotopes more effectively and safely than current standard treatments.
The company also received IND clearances in October 2024 for its lead therapeutic asset, ARC-706, and its companion diagnostic, ARC-166. These two products will be advanced into clinical development as a theranostic pair. ARC-706 is being explored for combination use with selected immunotherapies across various cancer types. Early data suggest this combination may generate durable responses and immune memory in cancers that do not typically respond to immunotherapy.
Archeus aims to progress several clinical trials this year, supported by its broader pipeline of radiopharmaceutical candidates focused on difficult-to-treat cancers.
Source: businesswire.com
