Omburtamab is under clinical development by Y-mAbs Therapeutics and currently in the Phase I, Phase II and Pre-Registration in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.
According to GlobalData, the latest event to affect Omburtamab’s likelihood of approval (LoA) and phase transition for Ependymoma took place on 16 Jun 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.
In addition, the same event on 16 Jun 2022 decreased Omburtamab’s Phase Transition Success Rate (PTSR) for Medulloblastoma, decreased LoA and PTSR for Melanoma, decreased PTSR for Primitive Neuroectodermal Tumor (PNET), and decreased LoA and PTSR for Sarcomas.
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Omburtamab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
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.
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