67Cu-SAR-trastuzumab / Clarity Pharma - LARVOL DELTA

Radioimmunotherapy using 64/67Copper labelled trastuzumab in mice bearing HER2-positve xenografts as a model for breast cancer therapy (SABCS 2025) - "These results demonstrate the potential of 64/67Cu-SAR-trastuzumab as a new theranostic approach for the treatment of HER2-positive cancer. This theranostic pair exhibit similar biodistribution in the same model, with the high tumor uptake of 64Cu-SAR-trastuzumab resulting in high quality PET images. 67Cu-SAR-trastuzumab effectively increased the survival of all treated groups."

IO biomarker • Preclinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Theranostics of HER2-positive cancer using Copper-64/67 Sarcophagine-trastuzumab (SNMMI 2025) - "SAR-trastuzumab was labelled with either 64Cu or 67Cu at room temperature with high (>99%) radiochemical yields and purity. PET/CT imaging 48 hours after administration with 64CuSAR-trastuzumab demonstrated excellent tumor uptake (Figure 1), with mean SUVmax = 21.0 ± 2.5. Biodistribution measurements of the labelled antibody conjugates confirmed the high tumor uptake at 48 hours, with 59 ± 7 % IA/g observed in the tumor for 67CuSAR-trastuzumab and 61 ± 6 % IA/g for 64CuSAR-trastuzumab."

Oncology • HER-2

Clarity expands pipeline in breast cancer with Cu-64/67 SAR-trastuzumab: Pre-clinical data published and trastuzumab supply agreement in place (Clarity Pharmaceuticals Press Release) - "Clarity Pharmaceuticals...is pleased to announce the addition of a new asset, 64/67Cu-SAR-trastuzumab, into the Targeted Copper Theranostic (TCT) portfolio. Pre-clinical data on SAR-trastuzumab has recently been published and Clarity has signed a Supply Agreement with EirGenix, Inc. ('EirGenix') for the clinical development and future commercial supply of clinical-grade GMP trastuzumab biosimilar, EG12014. The supply enables the development of a radiolabelled product using Clarity’s SAR Technology....Clarity intends to conduct a Phase 1/2a theranostic study with 64/67Cu-SAR-trastuzumab in HER2-positive breast cancer patients to address a significant unmet clinical need....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 model."

Commercial • New molecule • Preclinical • HER2 Positive Breast Cancer