Clarity Pharmaceuticals (ASX: CU6) has signed a deal with the Australian Institute for Bioengineering and Nanotechnology (AIBN), located within the University of Queensland, for the supply of the copper-64 (cu-64) isotope used in the manufacture of diagnostic 64Cu-SAR-bisPSMA.

Clarity will use the isotope to support the Phase III Clarify and Amplify registrational trials, an ongoing Co-PSMA (prostate-specific membrane antigen) investigator-initiated trial and the SECuRE theranostic trial, all based in Australia.

It will also benefit the advancement of Clarity’s pre-clinical schedule, including the SAR-bisFAP and SAR-trastuzumab theranostic programs.

Patient benefits

Clarity executive chair Dr Alan Taylor said the supply agreement would ultimately benefit Australian patients and their treating clinicians.

“This agreement builds on years of close ties between Clarity and the Australian scientific and clinical communities and reflects our strong focus on continued partnership and synergies that can be derived from these important collaborations,” he said.

“We are dedicated to working with leading research and development organisations and giving back to the scientific and clinical community in our country in order to get closer to our ultimate goal of improving treatment outcomes for people with cancer.”

Dr Taylor said Clarity was committed to exploring new ways to leverage its unique advantages in the development of targeted copper theranostics to bring new products for indications with high unmet needs.

Fast-track designation

The US Food and Drug Administration recently issued Clarity two fast-track designations (FTDs) for its 64Cu-SAR-bisPSMA product.

They will enable the company to accelerate the development of a treatment program in the pre-prostatectomy setting as well as in patients with biochemical recurrence of prostate cancer.

The company views the FTD awards to be indicative of a high unmet need in prostate cancer imaging, despite the use of first-generation PSMA products on the market.

Common cancer

Prostate cancer is the second most common cancer in men and the fifth leading cause of death in men worldwide.

Patients diagnosed with prostate cancer at later stages have poor treatment outcomes, indicating a high unmet need for early detection and better treatment options for metastatic castration-resistant prostate cancer.

The AIBN houses state-of-the-art radiochemistry facilities that will supply cu-64 every week to Australian sites and complement existing local supply agreements for the isotope.