Y-mAbs Announces Data to be Presented at SIOP 2021
The abstracts include the following oral presentation of DANYELZA, the Company’s approved therapy for the treatment of pediatric patients with relapsed or refractory high-risk neuroblastoma, which is currently also being evaluated for the treatment of osteosarcoma and other GD2-positive tumors:
- “Naxitamab treatment of refractory/relapsed high-risk neuroblastoma (R/R HR NB); subgroup analysis of updated efficacy and safety data for the registrational Phase II trial”, submitted by
SJD Barcelona Children's Hospitalin Barcelona, Spain
The abstracts also include the following poster presentation of omburtamab, the Company’s lead product candidate, which is currently being evaluated for the treatment of patients with CNS/Leptomeningeal metastasis from neuroblastoma, diffuse intrinsic pontine glioma (“DIPG”), and desmoplastic small round cell tumors (“DSRCT”):
- “Outcomes of intraventricular 131-I-8H9 and external beam radiotherapy in patients with medulloblastoma, ependymoma, and pineoblastoma,” submitted by
Memorial Sloan Kettering Cancer Center(“MSK”) in New York
Researchers at MSK developed DANYELZA® and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compounds.
About DANYELZA® (naxitamab-gqgk)
DANYELZA® (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA® includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.
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Source: Y-mAbs Therapeutics, Inc