Clarity has a number of R&D projects in its Discovery Program, including new pipeline products and second generation technology

64/67Cu-SAR-Trastuzumab

Clarity is also developing a new preclinical stage asset called 64/67Cu-SAR-Trastuzumab.

  • Combining the well-established trastuzumab antibody with Clarity’s proprietary SAR Technology enables the development of a copper-67 (Cu-67) based radioimmunotherapy (RIT) for HER2-positive breast cancer patients.
  • It is estimated that 316,950 women will be diagnosed with invasive breast cancer in 2025 in the US, with 42,170 dying from the disease1.
  • Human epidermal growth factor receptor 2 (HER2) is expressed in up to 20% of breast cancers and is associated with a more aggressive type of tumour and poor prognosis2.
  • Pre-clinical evidence shows dose-response reduction in tumour size and prolonged survival using 67Cu-SAR-trastuzumab compared to trastuzumab alone in a HER2-positive tumour mouse model3.
  • To secure supply of clinical-grade Good Manufacturing Practice (GMP) trastuzumab, Clarity signed a Supply Agreement with EirGenix, Inc. in February 2025.

SAR-bisFAP

Clarity is developing a new preclinical stage asset called 64/67Cu-SAR-bisFAP, a pan-cancer Targeted Copper Theranostic.

  • 64/67Cu-SAR-bisFAP is a proprietary fibroblast activation protein (FAP)-targeted radiopharmaceutical product that can be used with the perfect pairing of copper isotopes for the diagnosis and treatment of cancer.
  • The product has shown strong tumour targeting, retention and pharmacokinetic data in pre-clinical models.
  • FAP is expressed widely across a range of malignancies, opening a very large pan-cancer opportunity for both imaging and treatment of various cancers.

Clarity continues to expand its pipeline with a range of Discovery programs ongoing. The majority of the Discovery work is done in collaboration with Clarity’s academic partners and external commercial service providers. The funding of the Discovery research is partially supported by grants and the Australian R&D Tax Incentive.

1. Siegel et al. Cancer statistics, 2025. CA Cancer J Clin. 2025.
2. Exman et al. HER2-positive metastatic breast cancer: a comprehensive review. Clin Adv Hematol Oncol. 2021.
3. Rudd et al. Potential theranostics of breast cancer with copper-64/67 sarcophagine-trastuzumab. Chem Sci. 2025.