On July 27, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer,reported the acceptance of five oral presentations at the International Society of Pediatric Oncology ("SIOP") Virtual Annual Congress held October 14 through October 17, 2020 in Ottawa, Canada (Press release, Y-mAbs Therapeutics, JUL 27, 2020, View Source [SID1234562454]). The abstracts are publicly available online at View Source
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Naxitamab
The abstracts include the following presentations of naxitamab, one of the Company’s lead product candidates, which is currently being evaluated for the treatment of pediatric patients with relapsed or refractory high-risk neuroblastoma, osteosarcoma and other GD2-positive tumors:
"High-dose naxitamab (humanized-3F8) plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor (GM-CSF) for resistant osteomedullary neuroblastoma: major responses and outpatient treatment in a Phase II trial," submitted by MSK in New York
"Naxitamab-based chemoimmunotherapy for resistant high-risk neuroblastoma: preliminary results of HITS treatment," submitted by SJD Barcelona Children’s Hospital in Barcelona, Spain
"Telemedicine blood pressure monitoring after anti-GD2 monoclonal antibody immunotherapy during the COVID-19 pandemic," submitted by MSK in New York
Naxitamab has been accepted for priority review by the U.S. Food and Drug Administration ("FDA") for the treatment of patients with relapsed/refractory high-risk neuroblastoma. The FDA set an action date of November 30, 2020, under the Prescription Drug User Fee Act ("PDUFA").
Omburtamab
The abstracts also include the following presentation of omburtamab, the Company’s other 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"):
"Intracerebroventricular radioimmunotherapy using 131I-omburtamab for neuroblastoma central nervous system/leptomeningeal metastases, interim results from multi-center trial 101," submitted by Memorial Sloan Kettering Cancer Center ("MSK") in New York
During June 2020, we initiated the submission of the Biologics License Application ("BLA") for omburtamab under the FDA’s Rolling Review process and completion of the BLA submission is currently expected to take place over the next few weeks.
GD2-GD3 Vaccine
The abstracts also include the following presentation of the GD2-GD3 Vaccine, the Company’s vaccine candidate, which is currently being evaluated for high-risk neuroblastoma patients in remission:
"Favorable toxicity profile of bivalent GD2/GD3 neuroblastoma vaccine," submitted by MSK in New York