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

The ARTISAN trial is assessing the safety and anti-tumor activity of lead asset AB001 in patients with metastatic castration-resistant prostate cancer (mCRPC)

Two cohorts, 177Lu-PSMA naïve patients and 177Lu-PSMA experienced patients, have been dosed in line with study protocol

CAMBRIDGE, Mass., Jan. 12, 2026 /PRNewswire/ -- ARTBIO, Inc. ("ARTBIO"), a clinical-stage radiopharmaceutical company developing a new class of ²¹²Pb alpha radioligand therapies (ARTs), today commenced 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.

"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).

About ARTBIO
ARTBIO is a clinical-stage radiopharmaceutical company redefining cancer care by creating a new class of alpha radioligand therapies (ARTs). The unique ARTBIO approach selects the optimal alpha-precursor isotope (²¹²Pb) and tumor-specific targets to create therapeutics with the potential for highest efficacy and safety. The company's AlphaDirect™ technology, a first-of-its-kind ²¹²Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs with lead program AB001 in metastatic castration resistant prostate cancer currently in Phase 1 clinical trials. ARTBIO is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway's Radium Hospital. For more information, visit www.artbio.com and follow us on LinkedIn.

SOURCE ARTBIO