ARTBIO Announces FDA Clearance of IND Application for Lead Alpha Radioligand Therapy AB001

ARTBIO is developing AB001, a Pb212 prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, for the treatment of metastatic castration resistant prostate cancer (mCRPC)

Clinical studies will initiate in the U.S. and additional geographies are under consideration

CAMBRIDGE, Mass., Sept. 9, 2025 /PRNewswire/ -- ARTBIO, Inc. ("ARTBIO"), a clinical-stage radiopharmaceutical company developing a new class of Pb212 alpha radioligand therapies (ARTs), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for AB001, and confirmed the study may proceed. The news follows a recent Series B capital raise to advance the company's pipeline and proprietary technology platform for Pb212-based therapies. 

"AB001 is a novel PSMA-targeted and Pb212-based radioligand therapy designed to treat patients with metastatic prostate cancer, one that we believe has the potential to increase the radioligand dose rate to tumors without higher toxicity to normal tissues," said Margaret Yu, M.D., Chief Medical Officer of ARTBIO. "Following FDA review, our Phase 1 study may now move ahead. This is welcome news for patients who are eagerly awaiting new targeted treatment options and for investigators who are ready to begin screening patients for this trial."

AB001 had been previously administered to patients in a Phase 0 study conducted in Norway with encouraging biodistribution results in those participants. The report on this study was included as part of the IND.

"Despite the availability of many treatment options, metastatic prostate cancer is still not a curable disease, requiring additional innovative treatments," said Oliver Sartor, M.D., Director of the Transformational Prostate Cancer Research Center at East Jefferson General Hospital Cancer Center and ARTBIO Scientific Advisory Board Member. "I'm grateful for ARTBIO's dedication and passion in this area and am excited about the difference that AB001 could make for patients."

ARTBIO plans to initiate the Phase 1 clinical trial for AB001 across multiple sites in the U.S. by leveraging its distributed manufacturing network of production hubs, including leading radiopharmaceutical CDMOs like SpectronRx, PharmaLogic, and Nucleus Radiopharma.

Clinical trial supply will be enabled by ARTBIO's proprietary Pb212 generator technology, AlphaDirect™, with precursor isotopes being sourced from the U.S. Department of Energy. The company plans to enroll patients outside of the U.S. once additional regulatory approvals are secured.  

"This IND clearance represents critical progress in translating the unique biology of Pb212 into patient care," said Dr. Michael Morris, Professor of Medicine, Prostate Section Head at Memorial Sloan Kettering Cancer Center and ARTBIO Clinical Advisory Board Member. "With the ability to target radiation at the cellular level, this program has the potential to establish a new standard of care in metastatic prostate cancer."

About AB001
AB001 is an Alpha Radioligand Therapy (ART) consisting of a prostate-specific membrane antigen (PSMA)-targeted small molecule radiolabeled with Pb212. PSMA is commonly overexpressed in mCRPC and has become an attractive target for imaging agents and therapies.

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 (Pb212) 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 first in human 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