ARTBIO Receives FDA Approval for Groundbreaking Radioligand Therapy AB001, Targeting Prostate Cancer

ARTBIO Announces FDA Clearance for AB001 Radioligand Therapy

In a significant breakthrough for cancer treatment, ARTBIO, Inc. has revealed that the U.S. Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug (IND) application for AB001, a novel radioligand therapy targeting metastatic castration-resistant prostate cancer (mCRPC). This therapy utilizes a new class of lead Pb212 alpha radioligand therapies (ARTs), and its clearance allows ARTBIO to move forward with its Phase 1 clinical trial.

AB001 is particularly notable for its ability to target the prostate-specific membrane antigen (PSMA), a biomarker prevalent in patients with advanced prostate cancer. According to Dr. Margaret Yu, the Chief Medical Officer of ARTBIO, the therapy is designed not only to increase the radioligand dose rate directed at tumors but also to minimize the exposure of normal tissues to radiation. This potential for enhanced efficacy coupled with a reduced side effect profile could represent a game changer for patients with mCRPC who currently have limited treatment options.

Dr. Oliver Sartor, a prominent prostate cancer researcher, emphasized the dire need for innovative treatments in this area. He remarked, “Despite various available treatment options, metastatic prostate cancer remains an incurable disease, calling for new therapeutic approaches.”*

The company's extensive research prior to this IND approval included a Phase 0 study conducted in Norway, which provided encouraging biodistribution results among participants. This important data was pivotal in securing permission for the Phase 1 trial.

Future Clinical Trials

ARTBIO plans to initiate the Phase 1 clinical trial for AB001 at multiple sites across the U.S. This ambitious undertaking will leverage the company’s distributed manufacturing network, involving collaborations with leading radiopharmaceutical contract development and manufacturing organizations (CDMOs) like SpectronRx, PharmaLogic, and Nucleus Radiopharma. The ART supply will be enabled through ARTBIO’s innovative Pb212 generator technology, AlphaDirect™, which uses precursor isotopes sourced directly from the U.S. Department of Energy.

Looking ahead, ARTBIO also intends to enroll patients outside of the U.S. once it acquires the necessary regulatory approvals. This multi-faceted approach not only allows for a broader participant base but also enhances the likelihood of successfully advancing the therapy in combatting mCRPC.

Dr. Michael Morris, a respected figure in oncology and part of ARTBIO's Clinical Advisory Board, discussed the importance of this IND clearance, calling it a critical step in integrating the unique biology of Pb212 into clinical practice. He stated, “With the ability to target radiation at the cellular level, AB001 could establish a new standard of care in the treatment of metastatic prostate cancer.”

About ARTBIO

ARTBIO, Inc. is pioneering a new frontier in radiopharmaceuticals, focusing on creating sophisticated alpha radioligand therapies (ARTs). Their innovative approach combines optimal alpha-precursor isotopes like Pb212 with tumor-specific targets, aiming to deliver therapeutics that maximize safety and effectiveness. ARTBIO is on course to advance multiple pipeline projects to bring life-saving therapies to patients in need, depicting a dedicated commitment to transforming cancer treatment.

As the clinical landscape evolves, therapies like AB001 could transform treatment paradigms for patients battling metastatic prostate cancer, providing hope for better outcomes in the face of a challenging diagnosis. For more information about ARTBIO and its pioneering work, visit www.artbio.com and keep an eye on their journey on LinkedIn.