GD2-SADA is under clinical development by Y-mAbs Therapeutics and currently in Phase I for Melanoma. According to GlobalData, Phase I drugs for Melanoma have a 75% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how GD2-SADA’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

GD2-SADA overview

Monoclonal antibody conjugate is under development for the treatment of GD-2 positive solid tumor including neuroblastoma, small cell lung cancer, sarcoma and malignant melanoma. It comprises of anti-GD2 antibody conjugated to radioactive payload. It is being developed based on pre-targeted radioimmunotherapy platform SADA (Self-Assembly and DisAssembly) technology. It is administered through intravenous route. 

Y-mAbs Therapeutics overview

Y-mAbs Therapeutics(Y-mAbs) is a clinical biopharmaceutical company that develops and commercializes novel antibody therapeutic products for cancer treatment. The company technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform. Its pipeline products includes DANYELZA (naxitamab-gqgk), which targets tumors that express GD2, and omburtamab, which targets tumors that express B7-H3. DANYELZA is a humanized monoclonal antibody in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of in the bone or bone marrow stable disease to prior therapy and being evaluated for the treatment of other GD2-positive tumors. It also develops omburtamab, which is a novel murine monoclonal antibody targeting B7-H3. The Company is conducting Phase II clinical trials for the treatment of patients with first-line NB, third-line NB and relapsed osteosarcoma. It has a license and research collaboration agreement with Memorial Sloan-Kettering Cancer Center. Y-mAbs is headquartered in New York, the US.

For a complete picture of GD2-SADA’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 18 March 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.