ARTBIO Advances with Dosing of AB001 in Phase 1 Trial for Prostate Cancer

ARTBIO Initiates Dosing in ARTISAN Trial

CAMBRIDGE, Mass., Jan. 12, 2026 — ARTBIO, Inc., a pioneering clinical-stage radiopharmaceutical firm, has embarked on administering doses in its ARTISAN clinical trial, a Phase 1 study specifically designed for AB001. This promising therapy targets metastatic castration-resistant prostate cancer (mCRPC), a severe and challenging illness affecting many patients globally. The ARTISAN trial aims to evaluate both the safety and anti-tumor efficacy of AB001, which is making waves in the medical community.

The trial focuses on two patient cohorts: those who have not received prior treatment with radium-177 PSMA (177Lu-PSMA) and those who have. This dual approach emphasizes ARTBIO's commitment to understanding diverse patient responses based on previous treatments. According to Dr. Margaret Yu, the Chief Medical Officer at ARTBIO, this advancement is critical in providing new therapeutic options for patients suffering from mCRPC, marking a significant step forward in their clinical programs.

ARTBIO has set sights on conducting the ARTISAN trial across various clinical sites throughout the United States. Their roadmap for the trial includes plans to expand its reach outside the U.S. by late 2026, reflecting the company's ambition to provide broader access to potentially lifesaving treatments.

Dr. Munir Ghesani from United Theranostics, a key collaborator in the study, expressed pride in utilizing the infrastructure to support prostate cancer patients. His enthusiasm highlights a shared goal among medical professionals to innovate and improve treatment pathways for those battling cancer.

Equally optimistic, Dr. Brandon Mancini, Medical Director at BAMF Health and principal investigator for the trial, remarked on the transformative potential of AB001 PSMA-targeted therapy. He emphasized that this treatment could redefine survival strategies for patients with mCRPC who desperately need additional therapeutic avenues.

Understanding AB001

AB001 stands out as an Alpha Radioligand Therapy (ART), combining a prostate-specific membrane antigen (PSMA)-targeting small molecule with 212Pb, a radiolabeled isotope. The overexpression of PSMA in mCRPC makes it a compelling target for radiation therapy and imaging. AB001's innovative approach positions it as ARTBIO's lead therapeutic candidate. Earlier in September 2025, AB001 received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA), marking a significant milestone in its development.

The ARTISAN Study Overview

The ARTISAN study is an open-label, multi-center Phase 1 clinical trial. Its primary objectives include assessing the safety, tolerability, pharmacokinetics, biodistribution, and anti-tumor activity of AB001 in patients suffering from mCRPC. This comprehensive research framework aims to build a solid foundation of evidence around the therapeutic's efficacy and safety profile.

A New Era in Radiopharmaceuticals

ARTBIO is committed to redefining cancer care through the development of innovative alpha radioligand therapies (ARTs). Their unique approach pairs optimal alpha-precursor isotopes with tumor-specific targets, which is central to their mission of enhancing both efficacy and safety in cancer treatment. The introduction of the AlphaDirect™ technology, a groundbreaking method for 212Pb isolation, allows for robust distributed manufacturing of ARTs, ensuring timely and reliable delivery to patients. With multiple programs under development, AB001 remains at the forefront, promising to help reshape the treatment landscape for mCRPC patients.

For further information on the clinical trials associated with AB001, interested parties can visit clinicaltrials.gov.

ARTBIO exemplifies a tradition of scientific excellence, underpinned by nearly a century of pioneering research in radiation therapy from institutions such as the University of Oslo and Norway's Radium Hospital. For the latest updates on ARTBIO and its initiatives, visit their official website at artbio.com or follow them on LinkedIn.

Contact: ARTBIO

This article has been provided by ARTBIO as part of their efforts to inform the public about advancements in cancer treatment research.