Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company, has entered into a Master Services Agreement (MSA) and Clinical Manufacturing Agreement for the production of 67Cu-SAR-bisPSMA, a radiopharmaceutical treatment for prostate cancer.
This partnership with Nucleus RadioPharma, a leading contract development and manufacturing organisation (CDMO) in the radiopharmaceutical industry, is set to bolster Clarity’s manufacturing capabilities as it progresses toward a Phase III trial and eventual commercialization.
Clarity’s Executive Chairperson, Dr Alan Taylor, emphasised the importance of this collaboration: “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.”
He added, “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.
This agreement builds on Clarity’s earlier partnerships, including an agreement with NorthStar for the production of 67Cu-SAR-bisPSMA. The expanded supply chain will support the accelerating pace of the SECuRE trial, which has seen high demand from investigators.
Dr Taylor highlighted the need for additional manufacturing capacity: “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.”
The partnership also leverages Nucleus RadioPharma’s manufacturing expertise. With its state-of-the-art facility in Minnesota, Nucleus is capable of producing and distributing 67Cu-SAR-bisPSMA across all 50 US states.
Further, their expansion plans in Arizona and Pennsylvania align with Clarity’s development timeline, ensuring drug supply nationwide.
Dr Geoffrey Johnson, chief scientific officer at Nucleus RadioPharma, expressed his enthusiasm for the continued collaboration: “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.”
He noted the advantages of domestic production, stating, “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.”
Dr Taylor also emphasised the importance of a layered supply strategy to avoid logistical disruptions, which have been a challenge with other radiopharmaceuticals.
“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 commercialization, we intend to make logistical interruptions affecting patient care a thing of the past,” he concluded.
The Master Services Agreement and Clinical Supply Agreement are effective as of 8 November 2024, and will initially last for 36 months, with provisions for cancellation and extension in line with industry standards.
