Clarity Partners With Nucleus RadioPharma For Cancer Drug Production
Clarity partners with Nucleus RadioPharma to strengthen the supply chain for 67Cu-SAR-bisPSMA.
Breaking News
Nov 11, 2024
Simantini Singh Deo

Clarity has joined with Nucleus RadioPharma, a highly specialised CDMO that addresses the radiopharmaceutical space, through its entering a Master Services Agreement, a Clinical Manufacturing Agreement for next-generation radiotherapy developed in the form of a potential clinical candidate called 67Cu-SAR-bisPSMA. The new agreement expands on earlier MSAs and Clinical Supply Agreements Clarity established with NorthStar for producing 67Cu-SAR-bisPSMA, setting the company up to strengthen its supply chain ahead of Phase III trials and eventual commercialisation.
Clarity’s Executive Chairperson, Dr Alan Taylor, said in a statement, “We continue to strengthen our manufacturing network, ensuring prostate cancer patients needing novel radiopharmaceutical treatments can access what we believe is a best-in-class product, on time and demand. We have seen excellent data from the SECuRE3 trial and in case studies as part of the U.S. Food and Drug Administration (FDA) Expanded Access Program (EAP) with 67Cu-SAR-bisPSMA and look forward to progressing the development of this important therapy to address the large unmet need in prostate cancer care.”
He continued further by saying, “The strong demand from investigators for 67Cu-SAR-bisPSMA and our accelerating pace of the SECuRE trial recruitment make this the right time to invest in additional manufacturing capacity. Our long-standing relationship with NorthStar has put us in a unique position in radiopharmaceuticals, having both the therapeutic isotope and the finished product manufactured at one site. We have seen the failures in the supply of Pluvicto® by Novartis where vulnerable patients were left waiting for their treatments4-5 and have learnt from these mistakes.”
He even stated that, “At Clarity, we know that employing a layered supply strategy in anticipation of future demand is essential in radiopharmaceuticals. The use of the true theranostic pair, copper-64 and copper-67, allows for a readily scalable approach to product manufacture, which stands in stark contrast to currently used isotopes, such as gallium-68, fluorine-18 and lutetium-177, where supply and logistical complications are common. As we progress our development of Targeted Copper Theranostics (TCTs) and scale our supply to support later-phase clinical trials and eventual commercialisation, we intend to make logistical interruptions affecting patient care a thing of the past.”
Nucleus RadioPharma, a Minnesota-based company, is currently set up to manufacture and distribute 67Cu-SAR-bisPSMA across all 50 states in the U.S. Expansion of the manufacturing sites planned by the company for Arizona and Pennsylvania also aligns with Clarity's drug development schedule to cover a wide area of the country.
Nucleus RadioPharma’s Chief Scientific Officer, Dr Geoffrey Johnson, commented, “I am excited to continue collaborating with Clarity on developing its SAR-bisPSMA theranostic product. As a Principal Investigator on the SECuRE trial, I have seen first-hand how my patients benefited from the 67Cu-SAR-bisPSMA therapy. I am now pleased to support the development of this product on the supply chain side and that Nucleus RadioPharma will be producing doses of this novel drug for patients in the SECuRE trial and beyond as it continues to generate strong data.”
He also said, “Having the therapeutic copper-67 isotope produced domestically on purpose-built electron accelerators allows for reliable and scalable supply, free from the challenges of other therapeutic isotopes at this time, and Nucleus RadioPharma’s location in Rochester, MN allows seamless access to prestigious medical centres in the vicinity.”