Clarity Pharmaceuticals (ASX:CU6) has highlighted new clinical and commercial data supporting its proprietary copper-based theranostics platform, underscoring its potential to redefine imaging and therapy for prostate cancer.
Presenting at the Canaccord Drug and Device Conference, the company outlined the strength of its SAR-bisPSMA program and the advantages of its targeted copper theranostics (TCT) technology, which pairs copper-64 for imaging and copper-67 for therapy.
Clarity’s TCT platform is built around a proprietary SAR technology, which is a highly specific and stable chelator designed to retain copper isotopes securely. This pairing aims to deliver high accuracy and precision in diagnosing and treating a range of cancers, while also offering supply and logistical advantages over current theranostic options.
The company’s lead program, SAR-bisPSMA, targets prostate-specific membrane antigen (PSMA), expressed in most prostate cancers. It uses a unique dual-targeting dimer structure to increase tumour uptake and retention, delivering stronger signals and higher lesion detection rates than current first-generation PSMA PET agents. Preclinical and clinical data show significantly improved binding and internalisation compared with monomeric PSMA ligands.
Ongoing clinical development spans multiple late-stage trials. These include SECuRE (Phase I/IIa), CLARIFY (Phase III), and AMPLIFY (Phase III), all of which have received Fast Track designation from the U.S. Food and Drug Administration. Additionally, the Co-PSMA investigator-initiated trial led by Prof Louise Emmett at St Vincent’s Hospital Sydney has met its primary endpoint, demonstrating that 64Cu-SAR-bisPSMA PET/CT detects significantly more lesions per patient compared to standard-of-care 68Ga-PSMA-11 in low-PSA biochemical recurrence (BCR) patients.
<
The company presented data showing that its agent offers markedly improved lesion detection, including 2–3 times higher uptake and contrast and identification of more lesions compared to 68Ga-PSMA-11. In the COBRA study, next-day imaging with 64Cu-SAR-bisPSMA increased mean uptake metrics by more than 80% and tumour-to-background ratios by more than fivefold. This level of sensitivity enabled the identification of lesions months before detection by currently approved PSMA PET agents.
The total U.S. PSMA PET imaging market is estimated at US$2 billion annually, with first-generation agents currently dominating. Clarity is positioning its copper-based platform to displace these products by overcoming their low sensitivity limitations. With multiple late-stage programs advancing and strong clinical differentiation, the company is signalling its intent to become a major player in next-generation radiopharmaceuticals.