Full Press Release Details
177Lu-omburtamab-DTPA for the Treatment of Patients with Medulloblastoma Granted Rare Pediatric Disease Designation by FDA
New York, NY, October 7, 2021 (GLOBE NEWSWIRE) -Y-mAbs Therapeutics, Inc. ("Y-mAbs"
or the "Company"), 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 that the U.S. Food and Drug Administration
("FDA") has granted Rare Pediatric Disease Designation ("RPDD") for the Company's lutetium labelled omburtamab
antibody program for the treatment of medulloblastoma.
177Lu-omburtamab-DTPA, a monoclonal
B7-H3 antibody that has been radiolabeled with lutetium-177, is currently in a multicenter Phase 1 clinical trial in pediatric patients
with refractory medulloblastoma, and in a multicenter Phase 1 clinical trial targeting B7-H3 positive CNS/LM tumors in adults. We believe
that both indications address clear 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. Among
our leading compounds under development, four now have RPDDs, and this designation for 177Lu-omburtamab-DTPA further increase
our chances of ultimately receiving multiple PRVs," said Thomas Gad, founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer
further notes, "We are dedicated to bring 177Lu-omburtamab-DTPA to patients who desperately need alternative methods
of treatment. We are very pleased by this recognition by the FDA and look forward to expanding the ongoing Phase 1 studies with 177Lu-omburtamab-DTPA
into separate Phase 2 arms."
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 in the product.
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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