daretabart

Daretabart (hu1418K322A) is a humanized monoclonal antibody targeting the disialoganglioside GD2, which is highly expressed on neuroblastoma cells. Developed by Renaissance Pharma through a license from St. Jude Children's Research Hospital, it is designed for the treatment of high-risk neuroblastoma (HRNB). The antibody features a specific point mutation (K322A) in the CH2 domain of the Fc region, which is intended to reduce complement-mediated activation and the associated severe pain typically seen with other anti-GD2 therapies like dinutuximab. By binding to GD2, daretabart facilitates tumor cell lysis through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). It has received FDA Fast Track Designation and is being evaluated in the SHINE Phase II/III trial for patients with relapsed or refractory HRNB.

Other names

hu1418K322Ahu-1418K322Ahu 1418K322A