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Y-mAbs Therapeutics, a commercial-stage biopharmaceutical company, announced the publication of preclinical data on GD2-SADA at the 2024 ASCO Annual Meeting. The study details the binding properties of GD2-SADA, a bispecific fusion protein, to GD2-expressing cell lines and its anti-tumor efficacy when paired with Lutetium 177 (Lu177)-DOTA in pretargeted radioimmunotherapy (PRIT). The GD2-SADA protein showed high-affinity binding to lanthanide metal-DOTA complexes and negligible binding to trace metal-DOTA complexes, supporting its potential for targeted cancer treatment. These promising results pave the way for further clinical development in treating GD2-positive tumors in adults and adolescents.
Y-mAbs Therapeutics announced interim Phase 2 data for naxitamab at the 2024 ASCO Annual Meeting. The data from Trial 201 show a 50% overall response rate (ORR) in patients with relapsed/refractory high-risk neuroblastoma. Continued naxitamab treatment led to further disease reduction, with 25% achieving complete or partial response after three or more cycles.
Adverse events (AEs) were mostly mild to moderate, with 81% being Grade 1 or 2. Grade ≥3 AEs included hypotension (60%), pain (58%), and others. Notably, the frequency of severe pain and hypotension decreased over treatment cycles.
An independent study from Sant Joan de Déu Barcelona presented data on naxitamab combined with alternative chemotherapies, showing manageable safety profiles and better responses with prior chemo-immunotherapy sensitivity.
Y-mAbs reported U.S. DANYELZA® net product revenues of $18.6 million, an 11% YoY increase, while Worldwide DANYELZA net product revenues were $19.4 million, a 4% YoY decrease. Cash and cash equivalents stood at $75.7 million with a cash burn of $2.9 million. The Company reiterates full year 2024 financial guidance. First quarter marked highest U.S. demand for DANYELZA® since launch, with significant clinical advancements. Distribution partner initiated commercial launch in Latin America, abstracts to be presented at ASCO Annual Meeting. Financially, total net product revenues decreased by 4% YoY, with U.S. revenues increasing by 11%. Operating expenses and cash burn were within guidance, supporting operations into 2027.
