On December 2, 2025 Archeus Technologies, a company developing multiple differentiated radiopharmaceutical therapies for the treatment of patients with cancer, reported 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).
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ART-101 is a novel receptor-based targeting small molecule developed for the imaging and treatment of prostate cancer. The therapy was invented and developed by Reinier Hernandez, Ph.D., assistant professor of medical physics at the University of Wisconsin School of Medicine and Public Health and chief technology officer of Archeus Technologies, with substantial development support from the Wisconsin Alumni Research Foundation (WARF). ART-101 targets prostate-specific membrane antigen (PSMA), similar to several FDA-approved imaging and therapeutic agents. In preclinical studies, ART-101 has exhibited higher tumor uptake and retention, as well as lower normal tissue and salivary gland uptake, relative to current FDA-approved PSMA-targeting agents.
Through a collaboration agreement with WARF, the designated patent and licensing organization for the University of Wisconsin–Madison, Archeus is leading a first-in-human imaging study in mCRPC patients who are candidates to receive radioligand therapy with FDA-approved prostate cancer treatment Pluvicto (177Lu-PSMA-617). Participants will receive intravenous ART-101 – radiolabeled with the diagnostic isotope Indium-111 – to evaluate its safety, feasibility, biodistribution and kinetics, and tumor targeting.
"While current radioligand therapies provide a meaningful therapeutic benefit to patients with advanced prostate cancer, there are opportunities to even further enhance a patient’s quality of life and reduce even minimal side effects. This is especially important with upcoming alpha emitter-based therapies, where lower salivary gland uptake may help mitigate xerostomia," said Harshad Kulkarni, M.D., chief medical advisor at BAMF Health and principal investigator of the study. "As a vertically integrated comprehensive Theranostics center, BAMF Health was built to facilitate the next generation of theranostic agents. Our nationwide platform allows us to rapidly initiate and complete novel clinical trials like this, accelerating access to innovative options for patients."
"With significant development support, and promising preclinical data, ART-101 is an innovative therapeutic candidate with the potential to address key limitations of currently available radiopharmaceutical therapies for patients with prostate cancer," said Reinier Hernandez, Ph.D. "This clinical trial reflects Archeus’ foundational belief that precision imaging and dosimetry are essential to realizing the full potential of radiopharmaceutical therapy, as well as our commitment to advancing the broader portfolio and platform we are building."
(Press release, Archeus Technologies, DEC 2, 2025, View Source [SID1234661071])