Nucleus RadioPharma partners with ARTBIO for prostate cancer trial production

Nucleus RadioPharma, a company backed by GE HealthCare and Mayo Clinic, is advancing its mission in the field of radiopharmaceuticals. Following its establishment in October 2022, Nucleus has now entered into its first commercial partnership with ARTBIO, a clinical-stage radiopharmaceutical company. Under their agreement, Nucleus will manufacture ARTBIO’s Pb212-radiolabeled therapies from its facility in Rochester, Minnesota. These therapies are intended for ARTBIO’s phase 1 and 2 clinical trials of their lead prostate cancer program, AB001. Financial details of the deal were not disclosed.

Nucleus RadioPharma positions itself as the world’s first fully integrated development, manufacturing, and supply chain organization for radiopharmaceuticals. The company was conceived by venture capital firm Eclipse and the Mayo Clinic to address the significant manufacturing and supply chain challenges that have hindered the success of radiopharmaceuticals. Nucleus is actively developing multiple sites across the United States to streamline the production and delivery of these complex nuclear medicines. The aim is to reduce production timelines and alleviate supply chain issues, as explained by Nucleus' CEO Charles Conroy.

Radiopharmaceuticals, also known as radiotherapies, are specialized radioactive drugs used in both disease diagnosis and treatment, particularly for certain cancers. Despite the significant interest they have garnered in recent years, their intricate composition often leads to manufacturing and logistical challenges. For instance, Novartis, a prominent player in the field with products like Lutathera and Pluvicto, had to halt production temporarily in May 2022 due to quality concerns at their facilities in Italy and New Jersey. These issues have since been resolved, allowing Novartis to proceed with significant expansions in radiotherapy production.

Nucleus RadioPharma has underscored the widespread manufacturing and supply chain difficulties that have impeded the broader success of radiopharmaceuticals. To tackle these issues, the company secured an impressive $56 million in a series A investment round last October, led by Eclipse and GE HealthCare. This funding is being utilized to establish new facilities in the U.S.

ARTBIO, launched in 2022, quickly gained traction by securing a $90 million series A investment within six months of its inception. This funding is aimed at building out ARTBIO’s radiotherapy platform, enhancing its manufacturing capabilities, and advancing its lead asset into clinical trials.

The radiotherapy sector has seen a steady stream of partnerships and production advancements throughout 2024. In January, Novartis received FDA approval to commence large-scale production of Pluvicto at its state-of-the-art facility in Indianapolis. In February, Bayer partnered with PanTera to produce the alpha-emitting isotope actinium-225 (Ac-225) for clinical trials starting in the latter half of the year.

Additionally, Telix Pharmaceuticals from Australia has been expanding its footprint by acquiring Texas-based CDMO IsoTherapeutics and Canada’s ARTMS Inc., signaling further growth and consolidation in the radiopharmaceutical industry. These strategic moves underscore the increasing importance and rapid development within the field, promising improved treatment options and better management of supply and manufacturing challenges in the future.