[161Tb]Tb-ART-101 / WARF Therap, University of Wisconsin - Madison, Archeus Technologies - LARVOL DELTA

Archeus Technologies…announced that it has dosed the first patient in its Phase 1 clinical trial of ART-101 in men with metastatic castration-resistant prostate cancer (mCRPC) (Businesswire) - "Participants will receive intravenous ART-101 - radiolabeled with the diagnostic isotope Indium-111 - to evaluate its safety, feasibility, biodistribution and kinetics, and tumor targeting."

Trial status • Castration-Resistant Prostate Cancer

Preclinical efficacy safety and evaluation of [161Tb]Tb-ART-101 as next generation PSMA-targeted radiopharmaceutical for advanced prostate cancer (SNMMI 2025) - "Purpose/Background: [177Lu]Lu-PSMA-617 has proven effective in treating men with metastatic castration-resistant prostate cancer (mCRPC); however, disease progression and death remain inevitable. ART-101 and PSMA-617 were radiolabeled with 161Tb/177Lu, with radiochemical yields and purity (RCP) exceeding 95%, as confirmed by radio-TLC and radio-HPLC. Competitive binding assays revealed ART-101’s nanomolar affinity (Ki: 3.49 ± 0.3 nM) for the PSMA receptor. [161Tb]Tb-ART-101 was >90% stable in saline and human serum at 37°C for 72 hours."

Metastases • Preclinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Archeus Technologies Receives FDA Clearance of Investigational New Drug Application for ART-101 in Development for the Treatment of Prostate Cancer (Businesswire) - "Archeus Technologies...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ART-101, a novel receptor-based targeting small molecule that Archeus has developed for the imaging and treatment of prostate cancer. This IND clearance enables Archeus to initiate a Phase 1 clinical trial in men with metastatic castration-resistant prostate cancer (mCRPC), which is expected to start later this year....In addition, Archeus received IND clearances in October 2024 for its lead therapeutic candidate, ARC-706, and companion diagnostic, ARC-166. The company plans to advance the two assets - together as a theranostic pair - into clinical development this year."

IND • New P1 trial • Castration-Resistant Prostate Cancer