Core Insights - Y-mAbs Therapeutics, Inc. is focused on developing and commercializing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [1][4] - The company presented data on GD2-SADA in a trial for recurrent or refractory metastatic solid tumors expressing GD2 at the Advances in Neuroblastoma Research Meeting [1][2] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company with a focus on radioimmunotherapy and antibody-based cancer therapies [4] - The company’s product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma [4] Trial Information - The ongoing Phase 1 trial (Trial 1001, NCT05130255) evaluates the safety and tolerability of GD2-SADA Pretargeted Radioimmunotherapy (GD2-SADA PRIT) with Lutetium 177 DOTA (177Lu-DOTA) in patients with GD2-expressing solid tumors [2][5] - Part A of the trial focuses on dose escalation to determine the optimal safe dose of GD2-SADA and the administration interval between GD2-SADA and 177Lu-DOTA [2] Presentation Details - The trial data was presented in a poster format at the Advances in Neuroblastoma Research Meeting on May 26, 2025 [3] - The initial data readout from Trial 1001 is expected to be provided during a virtual Radiopharmaceutical R&D update on May 28, 2025 [3] Technology Overview - GD2-SADA is a bispecific fusion protein designed to bind to GD2 and Lutetium 177 DOTA, facilitating targeted radiotherapy [5] - The pre-targeted radiotherapy process involves an initial infusion of non-radiolabeled GD2-SADA followed by a second infusion delivering the radioactive payload for localized irradiation [5] Research Collaboration - The SADA technology for radioimmunotherapy was developed by researchers at Memorial Sloan Kettering Cancer Center and is exclusively licensed to Y-mAbs [6]
Y-mAbs Presents GD2-SADA PRIT Trial in Progress Poster at the Advances in Neuroblastoma Research Meeting