Clarity Pharmaceuticals announced the successful completion of cohort 2 and advancement to cohort 3 in the dose escalation phase of its Phase I/II theranostic trial, SECuRE, evaluating (64) Cu®? Cu SAR-bisPSMA in patients with mCRPC. 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 (64) Cu)/67) Cu SAR-bisPSMA.

If similar responses can be replicated in larger patient numbers, (67) Cu SAR- bisPSMA may become the gold standard therapeutic agent for patients with mCRPC once approved." Additional therapy cycles of (67) Cu SAR-bis PSMA have been requested by clinicians under the FDA EAP for patients who participated in the SECuRE trial. SPECT-CT images described below were collected 48 hours after the first, third and fourth administrations of 4GBq of (67) Cu SAR -bisPSMA in a patient from cohort 1 who received additional cycles under the EAP. Although data is early, the higher increase and retention of product, coupled with the advantageous properties of copper-67, has shown quite impressive responses from single doses and the company look forward to exploring the clinical benefits of (67) Cu SAR the higher 12GBq level and over multiple treatment cycles.

With commercial quantities of the (67) Cu radioisotope now being routinely produced domestically in the US by exclusive supplier, NorthStar, the company see a clear path to commercialisation as the company continue to push forward through clinical trials for (67) Cu SAR-bbisPSMA and bringing this product to the greater prostate cancer patient population.