ARTBIO Announces Dosing of Two Cohorts with AB001 in ARTISAN, a Phase 1 Alpha Radioligand Therapy Clinical Trial for Metastatic Castration Resistant Prostate Cancer

On January 12, 2026 ARTBIO, Inc. ("ARTBIO"), a clinical-stage radiopharmaceutical company developing a new class of 212Pb alpha radioligand therapies (ARTs), reported dosing of two cohorts in the U.S. as part of its ARTISAN Phase 1 clinical trial of AB001, an ART being developed for the treatment of metastatic castration resistant prostate cancer (mCRPC). Patient cohorts include those with and without prior treatment with Lu177-PSMA targeted therapy.

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"The ARTBIO team is excited to continue to advance AB001 as our lead clinical asset for patients with and without prior Lu177-PSMA targeted therapy," said Margaret Yu, Chief Medical Officer of ARTBIO. "We are proud to collaborate with team members at BAMF Health and United Theranostics and are especially grateful to the patients who have enrolled in this study."

The ARTISAN clinical trial is being conducted across multiple clinical trial sites in the U.S. The company plans to expand the ARTISAN trial outside of the US in the second half of 2026.

"I’m proud to support prostate cancer patients by using United Theranostics infrastructure to bring access to the ARTISAN trial and to bring a new therapeutic option to patients," said Dr. Munir Ghesani, Chief Medical Officer at United Theranostics. "The ARTBIO team are passionate innovators who have constructed this trial with a strong patient-centric mindset."

BAMF Health Medical Director and principal investigator for the trial, Dr. Brandon Mancini, said, "AB001 PSMA-targeted radioligand therapy has the potential to reshape the treatment landscape for patients with metastatic castration-resistant prostate cancer who urgently need additional pathways forward."

About AB001
AB001 is an Alpha Radioligand Therapy (ART) consisting of a prostate-specific membrane antigen (PSMA)-targeted small molecule radiolabeled with 212Pb. PSMA is commonly overexpressed in mCRPC and has become an attractive target for imaging agents and therapies. It is the lead program for ARTBIO. In September 2025, an Investigational New Drug (IND) application for AB001 was cleared by The U.S. Food and Drug Administration (FDA). For more information about AB001 clinical trials, visit www.clinicaltrials.gov.

About the ARTISAN Study
ARTISAN is an open label, multi-center phase 1 study to investigate the safety, tolerability, pharmacokinetics, biodistribution and antitumor activity of the alpha radioligand therapy AB001 in patients with metastatic castration resistant prostate cancer (mCRPC).

(Press release, ARTBIO, JAN 12, 2026, View Source [SID1234661992])