Clarity Pharmaceuticals has signed a Master Services Agreement (MSA) and Clinical Supply Agreement with Nucleus RadioPharma for the production of Clarity’s 67Cu-SAR-bisPSMA, a targeted radiopharmaceutical intended for prostate cancer treatment.

Under the agreements, Nucleus RadioPharma, a company founded by Eclipse and Mayo Clinic, will manufacture the drug at its new Rochester, Minnesota facility, which is designed to supply radiopharmaceutical products nationwide.

The partnership with Nucleus supplements Clarity’s existing agreement with NorthStar Medical Radioisotopes, further strengthening the manufacturing network to meet the anticipated demand for Phase II and III clinical trials. Clarity expects that the 67Cu-SAR-bisPSMA product will enter the cohort expansion phase of the SECuRE trial in early 2025, a critical stage in the drug’s clinical development.

Nucleus RadioPharma recently revealed expansion plans, which include new manufacturing sites in Arizona and Pennsylvania. These facilities, also covered under the MSA, will provide added production capacity for later trial phases and potential commercialization.

Dr. Alan Taylor, Clarity’s executive chairperson, highlighted the importance of a robust supply network for 67Cu-SAR-bisPSMA, particularly as recruitment in the SECuRE trial accelerates. He stated, “We have seen excellent data from the SECuRE trial and the FDA Expanded Access Program with 67Cu-SAR-bisPSMA and look forward to progressing this important therapy to address the large unmet need in prostate cancer care.”

The agreement is set for an initial three-year term and includes standard provisions for extension and cancellation. Both companies aim to streamline production for seamless clinical and potential commercial access to Clarity’s targeted copper theranostics in the U.S.

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