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

Development and preclinical characterization of [¹⁶¹Tb]Tb-ART-101 as a next-generation PSMA radiotherapeutic (SNMMI 2026) - "While [¹⁷⁷Lu]Lu-PSMA-617 radiopharmaceutical therapy (RPT) improves outcomes, ~50% of patients do not respond, and disease progression is inevitable. Our findings indicate that pairing ART-101's favorable pharmacology with the advantageous dosimetry of ¹⁶¹Tb significantly enhances the therapeutic efficacy of [¹⁶¹Tb]Tb-ART-101 without notable toxicity. Additional in vitro and in vivo studies are underway to validate these results in prostate cancer models with distinct molecular backgrounds, including LNCaP and C4-2. Collectively, these data support [¹⁶¹Tb]Tb-ART-101 as a promising next-generation PSMA-targeted radiopharmaceutical with strong potential for clinical translation in mCRPC."

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

Development and preclinical characterization of [¹⁶¹Tb]Tb-ART-101 as a next-generation PSMA radiotherapeutic (SNMMI 2026) - "While [¹⁷⁷Lu]Lu-PSMA-617 radiopharmaceutical therapy (RPT) improves outcomes, ~50% of patients do not respond, and disease progression is inevitable. Our findings indicate that pairing ART-101's favorable pharmacology with the advantageous dosimetry of ¹⁶¹Tb significantly enhances the therapeutic efficacy of [¹⁶¹Tb]Tb-ART-101 without notable toxicity. Additional in vitro and in vivo studies are underway to validate these results in prostate cancer models with distinct molecular backgrounds, including LNCaP and C4-2. Collectively, these data support [¹⁶¹Tb]Tb-ART-101 as a promising next-generation PSMA-targeted radiopharmaceutical with strong potential for clinical translation in mCRPC."

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

Next-Generation PSMA Therapy: [¹⁶¹Tb]Tb-ART-101 achieves superior tumor absorbed dose and anti-tumor efficacy in advanced prostate cancer (PSMA 2026) - No abstract available

Clinical • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

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