177Lu-omburtamab-DTPA by Y-mAbs for the treatment of patients
NEW YORK, Oct. 7, 2021 (GLOBE NEWSWIRE) – Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB), a commercial-stage biopharmaceutical company focused on development and commercialization new antibody-based therapeutics for the treatment of cancer, today announced that the United States Food and Drug Administration (“FDA”) has granted Rare Pediatric Disease (“RPDD”) designation for The Company’s lutetium-labeled omburtamab antibody program for the treatment of medulloblastoma.
177Lu-omburtamab-DTPA, a B7-H3 monoclonal antibody that has been radiolabeled with lutetium-177, is currently in a phase 1, multicenter clinical trial in pediatric patients with refractory medulloblastoma, and in a clinical trial Phase 1 multicenter targeting B7-H3 positive CNS / LM tumors in adults. We believe that both indications address clearly unmet medical needs.
“The RPDD makes us eligible for a Priority Review Voucher (‘PRV’) upon potential approval of the biologics license application for this rare pediatric cancer. Of our flagship compounds under development, four now have RPDDs, and this designation for 177Lu-omburtamab-DTPA further increases our chances of receiving multiple PRVs over time, ”said Thomas Gad, Founder, President and Chairman.
Dr Claus Moller, Chairman and CEO, adds: “We are committed to providing 177Lu-omburtamab-DTPA for patients in desperate need of alternative methods of treatment. We are very pleased with this recognition by the FDA and look forward to expanding the ongoing Phase 1 studies with 177Lu-omburtamab-DTPA in separate phase 2 arms.
Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed omburtamab, which is exclusively licensed by MSK at Y-mAbs. As a result of this license agreement, MSK has institutional financial interests in the product.
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel antibody-based therapeutics for the treatment of cancer. The Company has a broad portfolio of advanced products, including an FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and a pivotal stage candidate, omburtamab, which targets tumors that express B7-H3.
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“DANYELZA” and “Y-mAbs” are registered trademarks of Y-mAbs Therapeutics, Inc.
Y-mAbs Therapeutics, Inc.
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Email: [email protected]