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news.Archeus Technologies has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for ART-101.
The Phase I clinical trial is slated to commence later in the year. Credit: National Cancer Institute/ Unsplash.
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This new small molecule is designed for prostate cancer imaging and treatment.
The FDA’s approval allows Archeus to begin a Phase I clinical study targeting metastatic castration-resistant prostate cancer (mCRPC), anticipated to commence later in the year.
ART-101 was developed by Reinier Hernandez, an assistant professor of medical physics at the University of Wisconsin–Madison, with support from the Wisconsin Alumni Research Foundation.
It targets the prostate-specific membrane antigen (PSMA), a common target for both imaging and therapeutic agents approved by the FDA.
Preclinical studies suggest the therapy offers improved tumour uptake and retention, and reduced uptake in normal tissue and salivary glands, compared to existing PSMA-targeting agents.
Archeus aims to assess ART-101’s potential as a theranostic radiopharmaceutical agent, which is expected to release alpha particle-emitting isotopes more safely than the current standards of care.
Archeus Technologies CEO Evan Sengbusch said: “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.
“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.”
The company is engaged in developing radiopharmaceutical therapies for difficult-to-treat cancers types.
Archeus received IND clearances in October 2024 for ARC-706, its lead therapeutic candidate, and ARC-166, its companion diagnostic.
The company is preparing to move these assets into clinical development as a theranostic pair.
