Daiichi Sankyo Launches Phase I Trial for Enhertu Subcutaneous Formulation

Daiichi Sankyo Launches Phase I Trial for Enhertu Subcutaneous Formulation

Japan-based Daiichi Sankyo (TYO: 4568) has registered a Phase I clinical trial on ClinicalTrials.gov for the subcutaneous formulation of Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC), in metastatic solid tumors. The study is expected to enroll 76 patients with advanced solid malignancies.

Licensing Agreement with Alreogen
This development follows Daiichi Sankyo’s November 2024 licensing agreement with Korean biotech Alreogen for its proprietary Hybrozyme technology. Hybrozyme enables the development of subcutaneous trastuzumab deruxtecan, enhancing patient convenience through a more efficient administration route.

Financial Terms
Under the agreement, Daiichi Sankyo paid an upfront fee of USD 20 million and is committed to potential milestone payments totaling up to USD 280 million. The total deal value reaches USD 300 million, reflecting the significant potential of the subcutaneous formulation in expanding Enhertu’s therapeutic applications.-Fineline Info & Tech