Y-mAbs Announces FDA Clearance of IND for Lutetium-177 Labeled Omburtamab Antibody for Adult Indications
NEW YORK, Oct. 26, 2020 (GLOBE NEWSWIRE) -- 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 announced today that the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application for 177Lu-omburtamab-DTPA for the treatment of B7-H3 positive Central Nervous System (“CNS”) and Leptomeningeal Metastasis (“LM”) from tumors in adult patients.
177Lu-omburtamab-DTPA embodies the Company’s naked omburtamab antibody radiolabeled with lutetium-177, using DTPA to chelate the lutetium radioisotope to the antibody. Lutetium-177 is a beta-emitter with a half-life of 6.7 days and a maximum energy of 0.5 MeV, corresponding to a maximum soft-tissue penetration of approximately 1 mm from the binding site.
The Company anticipates that an international multicenter Phase 1/2 clinical trial will be opened for the screening of adult patients with CNS/LM from B7-H3 positive tumors during the fourth quarter of 2020.
“We are very pleased to move 177Lu-omburtamab-DTPA to the clinic. In this basket trial of B7-H3 positive CNS/LM cancers in adults, we hope to leverage our experience from treating more than 25 adults with 131I-omburtamab. 177Lu-omburtamab-DTPA is intended to address a clear unmet medical need for patients with B7-H3 positive brain metastasis, and we will open the study for the first adult patients during the fourth quarter of 2020. We are genuinely thrilled to widen our clinical reach for omburtamab to include adult indications,” said Thomas Gad, founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer further notes, “Based on our clinical experience with 131I-omburtamab for B7-H3 positive brain metastasis, we are excited to see 177Lu-omburtamab-DTPA make its way to the clinic to establish the safety profile and to determine the maximum tolerated dose.”
Researchers at Memorial Sloan Kettering (“MSK”) developed the omburtamab antibody, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound and in Y-mAbs.
About 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” is a registered trademark of Y-mAbs Therapeutics, Inc.
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Y-mAbs Therapeutics, Inc.
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