Archeus Technologies Doses First Patient with ART-101 in Phase 1 Prostate Cancer Study

MADISON, Wis.--(BUSINESS WIRE)--Archeus Technologies, a company developing multiple differentiated radiopharmaceutical therapies for the treatment of patients with cancer, today 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).

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.”

About Archeus Technologies

Archeus Technologies is a company developing radiopharmaceutical therapies for some of the most difficult-to-treat cancers. Starting with its Phase 1-ready therapeutic candidate, ARC-706, the company has assembled a growing pipeline of differentiated radiopharmaceutical therapy agents and companion diagnostic assets with the potential to provide curative responses to patients with advanced cancer. Archeus is led by an executive team with proven radiopharmaceutical expertise and a demonstrated record of advancing innovative agents from discovery through clinical development. In addition, Archeus has a long-standing strategic collaboration with the University of Wisconsin–Madison (UW), a global leader in radiopharmaceuticals and theranostics. To learn more, visit ArcheusTech.com.

About BAMF Health

BAMF Health is the world’s first vertically integrated platform for intelligence-based precision medicine. Headquartered in Grand Rapids, Michigan, BAMF Health employs the most advanced theranostic imaging technology to detect and treat cancer and other diseases and conduct advanced clinical trials. Our overriding mission is to empower patients to become people again. With a team of data scientists, researchers, software engineers, and clinicians—all working in lockstep—we’re making good on it. To learn more about BAMF Health, visit www.bamfhealth.com.

About Wisconsin Alumni Research Foundation (WARF)

Celebrating a century of service in 2025, the Wisconsin Alumni Research Foundation (WARF) patents and licenses discoveries from UW-Madison research, manages an investment portfolio generated from licensing and investment proceeds, and provides annual grants to the University of Wisconsin-Madison and the Morgridge Institute for Research to support further scientific investigation and research. By driving collaborations among researchers, investors, industry, and entrepreneurs, WARF commercializes innovations from campus through various programs. WARF Accelerator improves the commercialization potential of university intellectual property through industry engagement and investment in proof-of-concept milestones to validate market potential, demonstrate commercial value and de-risk technology. WARF Therapeutics partners with UW-Madison and Morgridge Institute researchers employing an industry-focused approach to improve the value propositions of drug candidates. WARF Ventures is an early-stage venture fund that invests in startups based on UW/WARF technologies. Learn more at warf.org.