China-based Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692) and its UK partner GSK plc (LON: GSK, NYSE: GSK) have announced that they have received another breakthrough therapy designation (BTD) from the US FDA for their B7-H3-targeted antibody drug conjugate (ADC), HS-20093 (GSK5764227). The indication this time is for the drug’s use in adult patients with recurrent or refractory osteosarcoma (bone cancer) that has progressed after second-line or higher treatment.
Drug Profile and Development
GSK5764227/HS-20093 is a novel investigational B7-H3-targeted ADC composed of a fully humanized anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor (TOPOi) payload. GSK struck a licensing deal with Hansoh in December 2023, taking global exclusive rights to the drug (excluding mainland China, Hong Kong, Macau, and Taiwan) for USD 185 million upfront and USD 1.525 billion in future milestone payments.
Previous Approvals and Designations
The drug obtained its first BTD in the US in August of last year for extensive-stage small-cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy (relapsed or refractory). Additionally, a BTD was granted by China’s National Medical Products Administration (NMPA) for ES-SCLC that has progressed after standard first-line treatment. Last month, the European Medicines Agency (EMA) granted the drug Priority Medicines (PRIME) Designation for recurrent ES-SCLC.
Significance of the BTD
The latest FDA BTD underscores the potential of GSK5764227/HS-20093 to offer new treatment options for patients with recurrent or refractory osteosarcoma, a condition with limited therapeutic options. This designation is expected to expedite the development and review process, bringing the drug closer to market and potentially improving patient outcomes.-Fineline Info & Tech
