Y-mAbs Announces Completion of Submission of Omburtamab Biologics License Application to FDA
NEW YORK, Aug. 06, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics Inc., 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, today announced that on August 5, 2020, the Company completed the submission of its Biologics License Application (“BLA”) under the FDA’s Rolling Review process for omburtamab. Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to present at a venue later this year.
“I am excited to see the completion of Y-mAbs’ second BLA submission this year in neuroblastoma. As children treated for high-risk systemic neuroblastoma potentially experience longer systemic remissions, we expect more patients eventually relapsing with brain metastasis and there is currently no standard therapy available for these patients. We believe this is a key milestone for families facing CNS/leptomeningeal metastasis from neuroblastoma and for Y-mAbs. As the father of a long-term high-risk neuroblastoma survivor with CNS/Leptomeningeal metastasis, I know how important this potentially is for families faced with brain metastasis from high-risk neuroblastoma,” stated Thomas Gad, Founder, Chairman and President.
Dr. Claus Moller, 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 look forward to working with the FDA to bring omburtamab to appropriate patients. Omburtamab is also being tested in a Phase 2 study for desmoplastic small round cell tumor and we are currently planning a Phase 2 study for diffuse intrinsic pontine glioma, as we believe omburtamab could potentially be developed for wider compartmental use.”
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 interests related to the compound and Y-mAbs.
Y-mAbs is a late-stage clinical 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 two pivotal-stage product candidates—naxitamab and omburtamab—which target tumors that express GD2 and B7-H3, respectively.
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Y-mAbs Therapeutics, Inc.
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