ARTBIO and Nucleus RadioPharma Announce Collaboration to Manufacture GMP-Grade Therapeutic Products Containing Radioisotope Pb-212 to Support Emerging Clinical Trials
May 07 2024 - 8:00AM
Business Wire
Partnership advances the production and
delivery of 212Pb-based therapies through ARTBIO’s proprietary
AlphaDirectTM isolation technology
Agreement signifies important milestone as
Nucleus RadioPharma’s first commercial partnership
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 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.
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.
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ARTBIO: Marites Coulter 415-819-2214
marites.coulter@vergescientific.com Nucleus RadioPharma: Patrick
Schmidt 630-290-2787 nucleusrad@consortpartners.com