Clarity Pharmaceuticals has added 64/67Cu-SAR-trastuzumab to its Targeted Copper Theranostic (TCT) portfolio, strengthening its renewed focus on breast cancer. The company has also signed a supply agreement with EirGenix, Inc. to secure clinical-grade trastuzumab biosimilar EG12014 for the product’s clinical development and potential commercialisation.
Pre-clinical data indicates that 67Cu-SAR-trastuzumab significantly reduces tumour size and prolongs survival in a HER2-positive tumour mouse model, demonstrating a dose-dependent response when compared to trastuzumab alone. The results highlight its potential as a radiopharmaceutical therapy for HER2-positive breast cancer.
HER2 is expressed in up to 20% of breast cancers and is associated with aggressive disease and poorer prognosis. With an estimated 316,950 women in the United States expected to be diagnosed with invasive breast cancer in 2025, and 42,170 projected to die from the disease, Clarity aims to address a significant unmet clinical need.
The addition of 64/67Cu-SAR-trastuzumab complements Clarity’s broader pipeline, which includes SAR-Bombesin, SARTATE, and SAR-bisPSMA. The company plans to conduct a Phase 1/2a theranostic study to evaluate the product’s clinical potential.
Dr Alan Taylor, Clarity’s executive chairperson, noted the growing role of antibodies in radiopharmaceuticals, stating that while antibody-drug conjugates (ADCs) have transformed cancer treatment, current radiopharmaceutical strategies remain suboptimal. He emphasised the importance of Clarity’s SAR Technology in expanding radiopharmaceutical applications beyond prostate cancer to larger oncology markets.
Taylor also highlighted the advantages of using copper isotopes, including the scalable production of copper-67 using basic linear accelerators rather than relying on scarce research reactors. He described the agreement with EirGenix as a key step in ensuring a reliable supply of 67Cu-SAR-trastuzumab for future trials.
Clarity continues to advance its radiopharmaceutical pipeline, aiming to develop targeted therapies that improve treatment outcomes for children and adults with cancer.
