• Clarity Pharmaceuticals recruits and treats its first patient in the therapeutic phase of its SAR-bisPSMA theranostic clinical trial SECuRE (NCT04868604)^[1] investigating Targeted Copper Theranostics (TCTs) in patients with metastatic castrate-resistant prostate cancer (mCRPC)
  
  
• Data from the initial dosimetry phase with 64Cu SAR-bisPSMA was assessed by the Safety Review Committee which recommended to move to therapeutic applications with 67Cu SAR-bisPSMA
  
  
• The promising preclinical and clinical results to date support Clarity's investigation of the optimised SAR-bisPSMA product in additional oncology indications where the theranostic approach may have utility

The SECuRE trial (NCT04868604)^[1] is a Phase I/IIa theranostic trial for identification and treatment of Prostate-Specific Membrane Antigen (PSMA) expressing mCRPC using Targeted Copper Theranostics (TCTs). ⁶⁴Cu SAR-bisPSMA is used to visualise PSMA expressing lesions and select candidates for subsequent ⁶⁷Cu SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion planned for up to 44 patients in the US. The aim of this trial is to determine the safety and efficacy of ⁶⁷Cu-SAR-bisPSMA as a therapy.

The SECuRE trial initially underwent the dosimetry phase with ⁶⁴Cu SAR-bisPSMA to determine product biodistribution and dosimetry over multiple time points. Upon the completion of the phase, the data was collected and reviewed by the Safety Review Committee, which has recommended the trial progresses into therapeutic applications with ⁶⁷Cu SAR-bisPSMA. The first patient in the therapeutic phase was treated at the Urology Cancer Center and GU Research Network in Omaha, Nebraska.

Dr Luke Nordquist, CEO, Urologic Medical Oncologist and Principal Investigator at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, commented, "We are excited to have successfully treated the first participant with the therapeutic ⁶⁷Cu SAR-bisPSMA product. The preclinical and preliminary clinical data to date indicates potential diagnostic and therapeutic benefits of the optimised PSMA agent and we look forward to generating further evidence as we progress the recruitment into the SECuRE trial.

"GURN is now recruiting participants in three clinical trials with Clarity's TCTs. We firmly believe that this next-generation platform will help to overcome the logistical and manufacturing challenges that currently plague the radiopharmaceutical field. With an on-demand distribution model that alleviates the reliance on antiquated nuclear reactors, TCTs hold great promise of shifting the treatment paradigm towards the patients and their treatment staff. This way, the clinicians can focus on providing the best patient care without the fear of reactor shutdowns or manufacturing outages disrupting the treatment process."

Clarity's Executive Chairman, Dr Alan Taylor, commented, "Clarity is excited to progress our second theranostic trial and continue exploring the benefits of TCTs. Prostate cancer is one of the largest oncology indications and there is a significant unmet need for improved diagnosis and therapy of patients with this insidious disease. Moreover, the preliminary data suggests the optimised PSMA product could deliver clinical benefits in oncology indications beyond prostate cancer, which we are excited to explore in the near future.

"Radiopharmaceuticals have a great opportunity of advancing the treatment paradigm for cancer patients, however, a number of challenges associated with the current generation products prevail. Firstly, production of currently approved therapeutic radiopharmaceuticals relies on an ageing fleet of nuclear reactors where shutdowns and interruptions are common. In addition, most currently approved therapeutic products need to be heated during the manufacturing process, which can cause potential quality issues. Finally, as the radiopharmaceutical field is expanding in the global oncology market, the environmental considerations, associated with inefficient supply chains and production of radioactive waste, become a concern.

"Clarity's TCTs are the next-generation platform that aims to resolve these challenges and enable the radiopharmaceutical field to expand significantly in the large oncology market, addressing multiple large cancer indications. Our therapeutic products are based on copper-67 radioisotopes produced on electron accelerators, which are relatively inexpensive and infinitely scalable in comparison to medical nuclear reactors. TCTs also do not require heating during the manufacturing process, making it less costly and minimising quality concerns. Production of TCTs has favourable environmental characteristics in comparison to the current generation of theranostics with smaller infrastructure footprint and minimal radioactive waste disposal issues. In a field with too many unforeseen product outages and manufacturing issues, TCTs enable reliable and sustainable supply of radiopharmaceuticals.

"Given the myriad of logistical and manufacturing advantages of TCTs, we are committed to further validating the promising preclinical and clinical data to date and driving SAR-bisPSMA development in prostate cancer as well as other oncology indications with high unmet need," said Dr Taylor.