Clarity signs Cu-64 Supply Agreement with UQ

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Stock Clarity Pharmaceuticals Ltd (CU6.ASX)
Release Time 5 Mar 2025, 9:57 a.m.
Price Sensitive Yes
 Clarity signs Cu-64 Supply Agreement with UQ
Key Points
  • Clarity signs agreement with University of Queensland for supply of copper-64 isotope
  • Copper-64 will support Clarity's clinical trials and pre-clinical programs
  • Agreement enhances Clarity's ongoing collaborations with UQ
Full Summary

Clarity Pharmaceuticals has signed a new agreement with the University of Queensland (UQ) advanced imaging at the Australian Institute for Bioengineering and Nanotechnology (AIBN) for the supply of copper-64 (Cu-64 or 64Cu) isotope. The copper-64 supply will be used to expand the manufacturing capability of the diagnostic 64Cu-SAR-bisPSMA product for Clarity's Phase III CLARIFY and AMPLIFY registrational trials in Australia, the ongoing investigator-initiated trial (IIT), Co-PSMA, at St Vincent's Hospital, Sydney, as well as the SECuRE theranostic trial in Australia. In addition to the ongoing clinical trials, the copper-64 supply will also support the advancement of Clarity's pre-clinical program, including SAR-bisFAP and SAR-trastuzumab theranostic programs. The AIBN houses an on-site cyclotron and state-of-the-art radiochemistry facilities which will be supplying copper-64 every week to Australian sites and will complement existing copper-64 supply agreements in Australia. This agreement enhances Clarity's ongoing collaborations with UQ, which include a number of research and development initiatives, including being an active participant in the Australian Research Council (ARC) Hub for Advanced Manufacture of Targeted Radiopharmaceuticals (AMTAR).

Guidance

Clarity's 64Cu-SAR-bisPSMA diagnostic agent has received two Fast Track Designations from the US FDA, which will enable the company to accelerate the development of the product in the pre-prostatectomy setting as well as in patients with biochemical recurrence of prostate cancer.