Clarity Pharmaceuticals has entered into a Master Services Agreement and Clinical Manufacturing Agreement with Nucleus RadioPharma to scale up the production of 67Cu-SAR-bisPSMA, a promising radiopharmaceutical treatment for prostate cancer. This collaboration aims to bolster Clarity's manufacturing capabilities as it advances toward a Phase III trial and eventual commercialization of the drug.
Addressing Unmet Needs in Prostate Cancer Treatment
Dr. Alan Taylor, Executive Chairperson of Clarity, emphasized the importance of this partnership in ensuring that prostate cancer patients have access to novel radiopharmaceutical treatments. "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 stated.
Clarity's 67Cu-SAR-bisPSMA has shown excellent data in the SECuRE3 trial and in case studies under the FDA's Expanded Access Program. The expanded supply chain, supported by this agreement and previous partnerships like the one with NorthStar, will accommodate the accelerating pace of the SECuRE trial, which has seen high demand from investigators.
Leveraging Nucleus RadioPharma's Manufacturing Expertise
Nucleus RadioPharma's state-of-the-art facility in Minnesota is equipped to produce and distribute 67Cu-SAR-bisPSMA across all 50 US states. Their expansion plans in Arizona and Pennsylvania align with Clarity's development timeline, ensuring nationwide drug supply.
Dr. Geoffrey Johnson, chief scientific officer at Nucleus RadioPharma, expressed his enthusiasm for the collaboration, noting the benefits he has observed firsthand as a Principal Investigator on the SECuRE trial. "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."
Ensuring Reliable and Scalable Supply
One of the key advantages of this partnership is the domestic production of the therapeutic copper-67 isotope using purpose-built electron accelerators. This approach allows for a reliable and scalable supply, mitigating the challenges associated with other therapeutic isotopes. Dr. Taylor also highlighted the importance of a layered supply strategy to avoid logistical disruptions, which have been a concern 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," Dr. Taylor concluded. The Master Services Agreement and Clinical Supply Agreement, effective as of November 8, 2024, will initially last for 36 months, with provisions for cancellation and extension in line with industry standards.
