On October 26, 2020 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 reported 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 (Press release, Y-mAbs Therapeutics, OCT 26, 2020, View Source [SID1234569046]).
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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.