Danyelza validates a flotation and an anticancer mechanism

This week’s US approval for Danyelza is a first for Y-mabs Therapeutics, a biotech that floated just two years ago, and a third for the anti-GD2 mechanism of action for high-risk neuroblastoma. Danyelza’s second-line label is broader than that of the incumbent, United Therapeutics’ Unituxin, including adults in addition to paediatric patients, and the new drug is dosed via a 30-minute, rather than 10 to 20-hour, infusion. The third approved anti-GD2 MAb is Apeiron’s Qarziba, but this is available only in the EU. Conversely, Unituxin is approved only in the US, and United pulled its EU application three years ago. Work with other modalities for targeting the GD2 antigen continues, not least by Y-mabs itself, which is working on bispecific and vaccine approaches in partnership with Memorial Sloan Kettering. Car-T therapies against GD2 have also proliferated, most notably from Autolus, but also including numerous projects in trials at hospitals in China. EvaluatePharma sellside consensus sees Unituxin and Danyelza posting 2026 revenues of $138m and $291m respectively, but side-effects will likely temper use of the drugs: both carry boxed warnings of serious infusion reactions and neurotoxicity.

Selected industry projects targeting GD2
Project Company Mechanism Status
Unituxin (dinutuximab) United Therapeutics Anti-GD2 MAb Marketed (US only)
Qarziba (dinutuximab beta) Apeiron/Eusa Pharma Anti-GD2 MAb Marketed (EU only)
Danyelza (naxitamab) Y-mabs Therapeutics Anti-GD2 MAb Approved (US only)
Nivatrotamab Y-mabs Therapeutics Anti-GD2 & CD3 bispecific MAb Phase 1/2
GD2-GD3 Vaccine Y-mabs Therapeutics Anti-GD2L & GD3L vaccine Phase 1/2
APN301 / EMD 273063 Aperion (ex Merck KGaA) Anti-GD2 & IL-2 fusion protein Phase 1/2
Auto6 Autolus Anti-GD2 Car-T therapy Phase 1
GD2CART NCI Anti-GD2 Car-T therapy Phase 1
1B7 / 31F9 Biontech (ex Mabvax) Anti-GD2 MAb Preclinical
Source: EvaluatePharma & company statements.

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