FDA Clears Archeus Technologies' Investigational New Drug Application for Prostate Cancer Treatment ART-101

Archeus Technologies, based in Madison, Wisconsin, has recently achieved a significant milestone in its quest to develop advanced radiopharmaceutical therapies for cancer treatment. The U.S. Food and Drug Administration (FDA) has granted clearance for the company's Investigational New Drug (IND) application for ART-101, a novel small molecule designed for imaging and treating prostate cancer. This approval allows Archeus to proceed with a Phase 1 clinical trial targeting men who suffer from metastatic castration-resistant prostate cancer (mCRPC), with the trial anticipated to commence later this year.

ART-101 is the brainchild of Dr. Reinier Hernandez, an assistant professor of medical physics at the University of Wisconsin–Madison. The development of ART-101 was supported by the Wisconsin Alumni Research Foundation. The therapy is designed to target the prostate-specific membrane antigen (PSMA), a protein that is also the focus of several other FDA-approved imaging and therapeutic agents. However, ART-101 is distinguished by its superior preclinical performance, exhibiting higher tumor uptake and retention along with reduced uptake in normal tissues and salivary glands when compared to current FDA-approved PSMA-targeting agents. Archeus Technologies envisions evaluating ART-101 as a theranostic agent, which could potentially deliver alpha-emitting isotopes more effectively and safely than existing treatment options.

Evan Sengbusch, Ph.D., the CEO of Archeus Technologies, expressed his enthusiasm about the IND clearance, remarking on its significance as a step towards launching several clinical trials from their diverse portfolio of innovative radiopharmaceutical assets aimed at treating difficult cancers. He sees ART-101 as a promising strategy for targeting PSMA-positive prostate cancer, with the potential to offer significant clinical benefits and fewer side effects for patients. Sengbusch emphasized the company’s eagerness to assess ART-101's therapeutic potential in clinical settings.

Furthermore, Archeus Technologies secured IND approvals in October 2024 for ARC-706, their leading therapeutic candidate, and ARC-166, its companion diagnostic. The company plans to advance these two assets into clinical development this year as a theranostic pair. ARC-706 is being developed for use in combination with certain validated immunotherapies across various cancer types. Preclinical studies suggest that this radiopharmaceutical and treatment approach may lead to curative outcomes and create immune memory against cancers that typically resist these immunotherapies.

Archeus Technologies is committed to advancing radiopharmaceutical therapies for challenging cancers. The company’s portfolio includes ARC-706, which is ready for Phase 1 trials, and an expanding array of innovative therapy agents and diagnostic tools that hold the promise of providing curative responses for patients with advanced cancer. The leadership team at Archeus boasts extensive experience in radiopharmaceuticals and has a strong track record in developing groundbreaking agents from discovery through clinical development. The company also benefits from a long-term strategic partnership with the University of Wisconsin–Madison, a renowned leader in the field of radiopharmaceuticals and theranostics.