Another Unituxin challenger follows Serb’s move

The UK’s Essential Pharma could soon gun for approval of the world’s fourth anti-GD2 antibody for a rare childhood brain cancer. The MAb in question, daretabart, has just entered the phase 2/3 Shine study in relapsed/refractory high-risk neuroblastoma, though it’s taken a while to get to this stage: phase 2 data backing the move, and showing a three-year survival rate of 86%, were published back in 2021. In the meantime daretabart – in common with two other anti-GD2 MAbs – has changed hands. The molecule was originated by St Jude Children’s Research Hospital and licensed to Renaissance Pharma, which Essential bought in 2024. Two approved drugs, Qarziba and Danyelza, were also the subject of acquisitions, respectively by Recordati of Eusa Pharma, and by Serb Pharmaceuticals of Y-Mabs last year. The first approval of an anti-GD2 MAb occurred 11 years ago, and concerned United’s Unituxin, whose 2025 sales fell 5% to $227m. Such relatively low revenues are likely a result of this niche indication being divided up among so many players, but presumably Essential is ready: the group has a declared focus on small, underserved or rare disease populations.

Clinical-stage anti-GD2 MAbs

Source: OncologyPipeline.