Clarity Pharmaceuticals (ASX: CU6), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, announced on 29 June 2026 the acceptance of comprehensive data on its SAR-bisPSMA products for presentation at the European Association of Nuclear Medicine (EANM) Annual Congress 2026, to be held in Vienna, Austria. The presentations will encompass significant findings related to both 64Cu-SAR-bisPSMA for imaging and 67Cu-SAR-bisPSMA for therapy in prostate cancer.
A top-rated oral presentation will feature data from the Co-PSMA investigator-initiated trial with 64Cu-SAR-bisPSMA. This trial demonstrated improved diagnostic performance of 64Cu-SAR-bisPSMA compared to standard-of-care 68Ga-PSMA-11 PET/CT in patients with biochemical recurrence of prostate cancer following radical prostatectomy and low PSA. Key improvements included a higher mean number of lesions (1.26 vs. 0.48), an increased true positive rate (71% vs. 29%), and a greater proportion of participants with a positive scan (78% vs. 36%). Additionally, a three-patient case report highlighted 64Cu-SAR-bisPSMA’s ability to detect prostate cancer recurrence after negative standard-of-care PSMA PET scans, with next-day imaging identifying a 2.25-fold increase in lesions and a 1.8-fold increase in tracer uptake, leading to changes in planned clinical management for all patients.
The therapeutic potential of 67Cu-SAR-bisPSMA will also be showcased through case reports from the Phase I/IIa SECuRE trial. Two participants with metastatic castration-resistant prostate cancer (mCRPC) achieved undetectable disease following treatment with 67Cu-SAR-bisPSMA. One patient experienced a PSA decline of 95.7% to 0.26 ng/mL, becoming undetectable after the third cycle, and remained undetectable at 33 weeks with no detectable metastatic disease on follow-up scans. The second patient’s PSA declined by 94.2% to 0.19 ng/mL, becoming undetectable at 8 weeks, with a complete response observed. Both participants experienced mostly mild and transient adverse events, reinforcing the clinical potential of 67Cu-SAR-bisPSMA.
Dr. Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, highlighted that these findings, including the Co-PSMA data published in European Urology, support the company’s ongoing registrational Phase III clinical trials. He noted that head-to-head data has consistently shown 64Cu-SAR-bisPSMA outperforming standard-of-care imaging under multiple conditions. The acceptance of these abstracts at EANM 2026 underscores the strength of the data generated by Clarity’s products and the promising prospects for SAR-bisPSMA to advance prostate cancer diagnosis and treatment.
