• Clarity has developed a proprietary FAP-targeted radiopharmaceutical product for cancer diagnosis and treatment
• The product, SAR-bisFAP, has shown strong tumour targeting, retention and pharmacokinetic data in pre-clinical models
• FAP is expressed widely across a range of malignancies, offering a pan-cancer opportunity for imaging and treatment

Clarity Pharmaceuticals (ASX: CU6) has announced the expansion of its pipeline with a novel fibroblast activation protein (FAP)-targeted radiopharmaceutical product for the diagnosis and treatment of cancer. The product, termed SAR-bisFAP, has shown strong tumour targeting, retention and pharmacokinetic data in pre-clinical models. FAP is expressed widely across a range of malignancies, opening a large pan-cancer opportunity for both imaging and treatment of various cancers. Clarity's Targeted Copper Theranostic (TCT) targeting FAP was developed with the intent of overcoming the low uptake and retention of other FAP-targeted radiopharmaceuticals. This was achieved by utilising novel chemistry and combining an industry-leading FAP inhibitor with Clarity's proprietary SAR chelator technology. The SAR Technology enables the use of copper-64 (64Cu) for imaging and copper-67 (67Cu) for targeted cancer treatment. Compared to a monomer equivalent (SAR-monoFAP), the dimer SAR-bisFAP has shown increased tumour uptake and retention over 24 hours in pre-clinical models. Additionally, the dimer 64Cu-SAR-bisFAP demonstrated approximately 4 times higher uptake in cancer compared to an industry standard FAP-targeted monomer, 68Ga-FAPI-46, at 1-hour post-injection. Clarity is currently conducting additional investigations to enable a Phase I clinical trial, which could commence in late 2025. The company is excited to continue growing its pipeline of TCTs through its Discovery Program, leveraging the unique advantages of copper isotopes enabled by its proprietary SAR Technology.

Clarity is currently conducting additional investigations to enable a Phase I clinical trial of its novel FAP-targeted radiopharmaceutical, SAR-bisFAP, which could commence in late 2025. The company is also exploring the potential clinical use of this agent in diagnostics and treatment of various cancers based on their unmet medical needs.