Clarity Pharmaceuticals announced the signing of a commercial-scale Supply Agreement for copper-64 with Nusano. Nusano's 190,000 square foot facility in West Valley City, Utah is expected to begin production in 2025 with copper-64 isotope supply planned to commence in early 2026. The accelerator-based proprietary technologies employed by Nusano are particularly well suited for cost-effective mass production of copper-64.
The Nusano facility is capable of producing more than 1,000 Ci (37,000 GBq) of copper-64 per day at capacity, which translates into more than 18,000 patient doses per day at 200 MBq per dose, with a 48-hour shelf-life, well in excess of commercial-scale demands across multiple large oncology indications in line with Clarity's commercialisation strategy. Nusano is also developing in-house production of the target material for copper-64 manufacturing, nickel-64 (Ni-64), and plans to commence production of copper-67 (Cu-67 or 67Cu) and actinium-225 (Ac-225 or 225Ac) isotopes in 2025-2026. Both of these isotopes are used in Clarity's pipeline of theranostic products in development.
Clarity's Executive Chairperson, Dr Alan Taylor, commented, "The signing of this Supply Agreement with Nusano will complement Clarity's existing network of US-based copper-64 suppliers, providing capacity to ensure abundant and seamless supply of the isotope. As Clarity is generating exceptional data in a number of late-stage clinical trials, now also have a cost-effective, large-scale supply strategy locked in for the commercial roll-out of Targeted Copper Theranostics (TCTs) in the largest healthcare market in the world, the US. This Agreement is an important part of a larger commercial manufacturing strategy, which will continue implementing as the filing of New Drug Applications (NDA) with the US Food and Drug Administration (FDA).
Nusano's Chief Executive Officer, Chris Lowe, commented, "Nusano is commercialising a breakthrough radioisotope production platform in 2025 capable of producing more than 25 radioisotopes for life science applications, including copper-64, copper-67 and actinium-225. The Supply Agreement is effective as of 16 April 2025 and is for an initial period of 3 years with automatic renewal for successive 2-year periods. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers.
