Archeus Technologies Receives FDA Clearance of Investigational New Drug Application for ART-101 in Development for the Treatment of Prostate Cancer

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

ART-101 was discovered and developed by Reinier Hernandez, Ph.D., assistant professor of medical physics at the University of Wisconsin–Madison, with robust development support from the Wisconsin Alumni Research Foundation. The therapy targets prostate-specific membrane antigen (PSMA), similar to several FDA-approved imaging and therapeutic agents. However, preclinical data demonstrates that ART-101 exhibits higher tumor uptake and retention, as well as lower normal tissue and salivary gland uptake, relative to current FDA-approved PSMA-targeting agents. Archeus plans to evaluate ART-101 as a theranostic radiopharmaceutical agent with the potential to deliver alpha particle-emitting isotopes with greater efficacy and safety compared with current standards of care.

“This IND clearance marks an important milestone for Archeus as we prepare to initiate the first of multiple clinical trials set to begin this year from our broader portfolio of differentiated radiopharmaceutical assets for difficult-to-treat cancers,” said Evan Sengbusch, Ph.D., chief executive officer of Archeus Technologies. “ART-101 represents a promising approach to targeting PSMA-positive prostate cancer with the potential to deliver meaningful clinical benefit and reduced side effects for patients. We are eager to begin evaluating ART-101 in patients to better understand its full therapeutic potential.”

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. Archeus is developing ARC-706 for combination use with certain validated immunotherapies across a range of cancer types. Preclinical data indicate that this radiopharmaceutical agent and treatment paradigm may produce curative responses, as well as immune memory against cancers that are otherwise resistant to these immunotherapies.

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.