ARTBIO and Nucleus RadioPharma Announce Collaboration to Manufacture GMP-Grade Therapeutic Products Containing Radioisotope Pb-212 to Support Emerging Clinical Trials
Partnership advances the production and delivery of 212Pb-based therapies through ARTBIO’s proprietary AlphaDirect™ isolation technology
Agreement signifies important milestone as Nucleus RadioPharma’s first commercial partnership
CAMBRIDGE, Mass. and ROCHESTER, Minn. ─ May 7, 2024 ─ ARTBIO, Inc. (ARTBIO), a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (ARTs), and Nucleus RadioPharma Inc. (Nucleus), the world’s first fully integrated development, manufacturing, and supply chain organization for radiopharmaceuticals, today announced a strategic manufacturing and supply agreement to support ARTBIO’s therapeutic product manufacturing.
Under the terms of the agreement, Nucleus will manufacture ARTBIO’s 212Pb-radiolabeled therapies for its planned Phase I and II clinical trials of its lead program in prostate cancer, AB001, using ARTBIO’s proprietary AlphaDirect™ 212Pb isolation technology. This agreement will enable the supply and manufacturing of ARTs from Nucleus’ facility in Rochester, Minn., for patients living in the Northern and Midwest U.S.
“As we continue building our distributed manufacturing capabilities in the U.S. and globally, selecting partners who share our patient-centric vision is critical,” said Emanuele Ostuni, Ph.D., Chief Executive Officer of ARTBIO. “The Nucleus team shares our passion to make targeted radiopharmaceutical therapies accessible, and together, we commit to bringing a new class of alpha radioligand therapies to hospitals across greater Minnesota and beyond.”
"This strategic partnership with ARTBIO underscores our unwavering commitment to transforming the lives of cancer patients through groundbreaking therapies," said Charles S. Conroy, Chief Executive Officer of Nucleus. "We are thrilled to unite in our mission to address the pressing need for innovative radiopharmaceuticals, ensuring that patients have access to potentially life-changing treatments with highest quality and supply chain resilience."
AlphaDirect™ is a first-of-its-kind system that delivers highly pure 212Pb from widely available raw materials. 212Pb is an alpha-emitting radioisotope that has gained attention for its potential applications in therapeutic medicine, particularly in targeted alpha radioligand therapy due to the radioisotope’s attractive short half-life and other properties. Preliminary studies of radiopharmaceuticals labeled with 212Pb have been promising, indicating that 212Pb has the potential to address unmet clinical needs.
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 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 and Twitter.
About Nucleus RadioPharma
Nucleus RadioPharma is an innovative CDMO in the radiopharmaceutical industry, dedicated to the development and manufacturing of targeted radiotherapies. With an emphasis on innovation and quality, the company provides an array of services, from formulation and analytical development to regulatory documentation and drug product manufacturing. Nucleus RadioPharma’s technology platforms are at the forefront of radiopharmaceutical research, designed to advance new therapies through clinical trials to commercialization. Recognized for its flexible approach, the company offers multiple onboarding points to accommodate innovators at various stages of their product lifecycle. Please visit nucleusrad.com and follow on LinkedIn for more information.