ARTBIO and Nucleus RadioPharma to Collaborate on GMP-Grade Pb-212 Therapeutics for Clinical Trials

ARTBIO and Nucleus RadioPharma have announced a significant agreement aimed at supporting the production of innovative cancer therapies. ARTBIO, a clinical-stage company developing alpha radioligand therapies, and Nucleus RadioPharma, an integrated radiopharmaceutical development and manufacturing organization, have formalized a strategic manufacturing and supply agreement.

This partnership will see Nucleus manufacturing ARTBIO’s 212Pb-radiolabeled therapies, particularly for its lead prostate cancer program, AB001. These therapies are prepared using ARTBIO’s proprietary AlphaDirectTM 212Pb isolation technology. The purpose of this collaboration is to ensure the effective production and supply of these therapies from Nucleus’ facility in Rochester, Minnesota, targeting patients in the Northern and Midwest United States.

Emanuele Ostuni, Ph.D., Chief Executive Officer of ARTBIO, emphasized the importance of choosing partners who share their patient-focused vision. He expressed confidence that the partnership with Nucleus would help make targeted radiopharmaceutical therapies accessible to more patients.

Charles S. Conroy, Chief Executive Officer of Nucleus, echoed these sentiments, highlighting the partnership's alignment with their mission to transform cancer treatment through innovative therapies. He emphasized their commitment to ensuring that patients have access to these potentially life-changing treatments with the highest quality and supply chain resilience.

The AlphaDirectTM system is notable for delivering highly pure 212Pb from widely available raw materials. 212Pb is an alpha-emitting radioisotope that has shown promise in therapeutic medicine due to its short half-life and other beneficial properties. Preliminary studies of therapies labeled with 212Pb have been promising, suggesting the potential to meet various unmet clinical needs.

ARTBIO is focused on redefining cancer treatment by creating alpha radioligand therapies (ARTs). Its approach involves selecting the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to develop therapies with high potential efficacy and safety. The company’s AlphaDirect™ technology enables a distributed manufacturing approach, ensuring reliable production and delivery of these therapies. ARTBIO is currently advancing multiple pipeline programs, with AB001 in the early stages of clinical trials. The company’s foundation is built on nearly a century of pioneering radiation therapy research from the University of Oslo and Norway’s Radium Hospital.

Nucleus RadioPharma, on the other hand, is dedicated to developing and manufacturing targeted radiotherapies, offering services from formulation and analytical development to regulatory documentation and drug product manufacturing. Their technology platforms are designed to advance new therapies from clinical trials to commercialization, ensuring flexibility for innovators at various stages of their product lifecycle.

This partnership represents a critical milestone for both companies, marking Nucleus RadioPharma’s first commercial partnership and advancing ARTBIO’s mission to bring innovative cancer treatments to patients in need. The collaboration aims to leverage both companies' strengths to deliver effective and reliable cancer therapies, addressing significant gaps in current treatment options.