Y-mAbs Reveals Preclinical GD2-SADA Data at 2024 ASCO

Y-mAbs Therapeutics, Inc. (Y-mAbs) recently announced the publication of its preclinical GD2-SADA data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting held from May 31 to June 4 in Chicago, Illinois. The abstract, titled "Preclinical characterization of pretargeted radioimmunotherapy with GD2-SADA, a self-assembling and disassembling bispecific fusion protein," details the properties of GD2-SADA and its efficacy in pretargeted radioimmunotherapy (PRIT) using Lutetium 177 (Lu177)-DOTA.

The research highlights GD2-SADA's binding properties to GD2-expressing cell lines and lanthanide metal-DOTA complexes. GD2, a glycolipid associated with multiple solid tumors, showed enhanced binding with GD2-SADA due to a p53-derived domain that facilitates the self-assembly and disassembly of GD2-SADA tetramers. These tetramers have four separate GD2-binding domains that collectively strengthen binding. Additionally, previous research indicates that unbound GD2-SADA proteins disassemble over time, allowing for efficient clearance by the kidneys.

Vignesh Rajah, MBBS, DCH, MRCP (UK), Chief Medical Officer at Y-mAbs, commented on the promising nature of the GD2-SADA data, stating that it supports the continued advancement of the SADA PRIT technology platform and its clinical programs. Further analysis revealed that GD2-SADA exhibits high-affinity binding to DOTA complexes chelated with lutetium and lanthanum, but negligible binding to trace metal-DOTA complexes or empty DOTA. This selective binding is crucial for the targeted radioactive payload delivery in patients.

Brian H. Santich, Ph.D., lead author and co-inventor of the SADA PRIT technology platform, expressed enthusiasm about the selective binding of GD2-SADA to lanthanide metal-DOTA complexes, which have applications in diagnosing and treating solid tumors. The study's findings underscore the robust and dose-responsive anti-tumor effects of GD2-SADA Lu177 PRIT, laying the groundwork for the clinical development of GD2-SADA PRIT in patients with GD2-positive tumors, as indicated by trial number NCT05130255.

Y-mAbs representatives will be available for further discussion at booth #35151 on the Exhibition Floor of McCormick Place. Notably, the SADA technology for radioimmunotherapy was developed by researchers at Memorial Sloan Kettering Cancer Center (MSK), including Dr. Nai-Kong Cheung. The technology is exclusively licensed to Y-mAbs, and Dr. Cheung holds intellectual property rights, with MSK having institutional financial interests in the technology.

Y-mAbs is a commercial-stage biopharmaceutical company dedicated to developing and commercializing novel radioimmunotherapy and antibody-based cancer treatments. Their technologies include the investigational SADA Pretargeted Radioimmunotherapy Platform (PRIT) and bispecific antibodies developed using the Y-BiClone platform. The company's product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after partial or minor responses, or stable disease from prior therapy.

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