On November 10, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that it has entered into an MSA and Clinical Manufacturing Agreement for 67Cu-SAR-bisPSMA with Nucleus RadioPharma, an innovative contract development and manufacturing organisation (CDMO) in the radiopharmaceutical industry, dedicated to the development and manufacturing of targeted radiotherapies (Press release, Clarity Pharmaceuticals, NOV 10, 2024, View Source [SID1234648058]).

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This agreement builds on the earlier MSA and Clinical Supply Agreements with NorthStar for the production of 67Cu-SAR-bisPSMA1, allowing Clarity to continue building supply chain capacity ahead of a Phase III trial and commercialisation with this product.

Nucleus RadioPharma’s facility in Minnesota enables 67Cu-SAR-bisPSMA manufacturing and distribution to all 50 states in the U.S. Their recently announced expansion plans for building additional manufacturing capacity in Arizona and Pennsylvania2 are also in line with the timelines for development of Clarity’s 67Cu-SAR-bisPSMA product, ensuring broad drug supply throughout the U.S.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We continue to strengthen our manufacturing network, ensuring prostate cancer patients in need of novel radiopharmaceutical treatments can get access to what we believe is a best-in-class product, on time and on 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.

"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 very unique position in radiopharmaceuticals, having both the therapeutic isotope and 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.

"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 continue to progress our development of Targeted Copper Theranostics (TCTs) and scale our supply in support of later-phase clinical trials and eventual commercialisation, we intend to make logistical interruptions affecting patient care a thing of the past."

Nucleus RadioPharma’s Chief Scientific Officer, Dr Geoffrey Johnson, commented, "I am excited to continue my collaboration with Clarity on the development of its SAR-bisPSMA theranostic product. Being a Principal Investigator on the SECuRE trial, I have seen first-hand how my patients have benefited from the 67Cu-SAR-bisPSMA therapy. I am now pleased to support the development of this product on the supply chain side as well 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. 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."

The Master Services Agreement and Clinical Supply Agreement are effective as of 8 November 2024 and are for an initial period of 36 months. Cancellation and extension provisions are aligned with industry standard rates.