Y-mAbs Provides Regulatory Update on Omburtamab
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) announced a regulatory update for its investigational monoclonal antibody omburtamab, which targets B7-H3 for treating pediatric CNS metastasis from neuroblastoma. Following a Type B meeting with the FDA, additional data requests were made regarding historical control groups. Y-mAbs aims to resubmit its Biologics License Application (BLA) by mid-2021, with further discussions scheduled for June 1. The company is also targeting a Marketing Authorization Application submission to the European Medicines Agency by April 30, 2021.
- Omburtamab could potentially become the first FDA-approved treatment for CNS metastasis from neuroblastoma in pediatric patients.
- The company is actively engaging with the FDA and scheduling follow-up meetings to expedite the approval process.
- Successful resubmission of the BLA could significantly enhance Y-mAbs' market position.
- The FDA has requested additional data, which could delay the approval timeline for omburtamab.
- There is a risk of not achieving regulatory approval for omburtamab, affecting future revenue potential.
NEW YORK, April 20, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced a regulatory update for omburtamab, which is an investigational, monoclonal antibody that targets B7-H3 and has been radiolabeled before intraventricular central nervous system (“CNS”) administration. B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types.
Y-mAbs recently concluded a Type B meeting with the U.S. Food and Drug Administration (“FDA”) regarding omburtamab and received requests from the FDA for additional data concerning the granularity of data from our identified historical control groups. In order to agree on a statistical analysis plan (“SAP”), this additional granularity data is being collected and we anticipate submitting it to the FDA by the end of April. An additional Type B meeting has been scheduled for June 1, 2021 to discuss the SAP based on review of the additional data. We continue to be in close dialog with the FDA and maintain our aim of resubmitting the Biologics License Application (“BLA”) for omburtamab late in the second quarter or in the third quarter of 2021.
"We believe omburtamab is on track to potentially become the first FDA approved targeted therapy for pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, addressing an important unmet medical need, where no standard therapy is currently available," said Thomas Gad, founder, Chairman and President of Y-mAbs.
Dr. Claus Moller, the Company’s Chief Executive Officer, continued, “We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastasis from neuroblastoma, and we continue to work closely with the FDA to resubmit the omburtamab BLA. In addition, we are targeting submission of a Marketing Authorization Application to the European Medicines Agency on April 30, 2021.”
Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interest related to the compound and Y-mAbs.
About Y-mAbs
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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“Y-mAbs®” and “DANYELZA®” are registered trademarks of Y-mAbs Therapeutics, Inc.
Contact:
Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
USA
+1 646 885 8505
E-mail: info@ymabs.com
FAQ
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