Omburtamab is under clinical development by Y-mAbs Therapeutics and currently in Phase II for Melanoma. According to GlobalData, Phase II drugs for Melanoma have a 27% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Omburtamab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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.

Omburtamab overview

Monoclonal antibody conjugate is under development for the treatment of refractory central nervous system (brain) tumor, atypical teratoid rhabdoid tumor, leptomeningeal neoplasms, neuroblastoma metastatic, adrenocortical carcinoma, ependymoma, sarcomas, melanoma, medulloblastoma, primitive neuroectodermal tumor (PNET), pediatric diffuse intrinsic pontine glioma, desmoplastic small round cell tumor of peritoneum and Wilms' tumor. It is administered through intrathecal, intraperitoneal and intracerebroventricular routes. The monoclonal antibody 8H9 is an IgG1 antibody and it is tagged with 131I, 124I, to elicit radioactivity towards tumor cells, with specificity for B7H3 antigen. B7-H3, assigned as CD276 is a type I trans-membrane protein structurally related to the B7 family of ligands by the presence of a single set of immunoglobulin-V-like and immunoglobulin-C-like (VC) domains. It acts by targeting the CD276 antigen. It was also under development for ovarian cancer and retinoblastoma.

It was under investigation for the treatment of metastatic brain cancer.

Y-mAbs Therapeutics overview

Y-mAbs Therapeutics(Y-mAbs) is a clinical biopharmaceutical company. It 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. The Company product pipeline 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 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 in relapsed osteosarcoma. It has a license and research collaboration agreement with Memorial Sloan-Kettering Cancer Center. Y-mAbs is headquartered in New York City, New York, the US.

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


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.