On 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, reported a strategic manufacturing and supply agreement to support ARTBIO’s therapeutic product manufacturing (Press release, ARTBIO, MAY 7, 2024, View Source [SID1234642823]).
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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 AlphaDirectTM 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."
AlphaDirectTM 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.