On June 4, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Dr. Mark Souweidane, Memorial Sloan Kettering Cancer Center ("MSK") and Weill Cornell Medicine will present interim phase 1 dose-escalation data for omburtamab for diffuse intrinsic pontine glioma ("DIPG") at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Virtual Annual Meeting on June 4, 2021 (Press release, Y-mAbs Therapeutics, JUN 4, 2021, View Source [SID1234583571])
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The phase 1 dose-escalation study with administration via convection enhanced delivery ("CED"), showed that dosing of omburtamab radiolabeled with 8 mCi of 124-Iodine appeared to be well-tolerated and provided distribution volume to potentially cover tumor volumes of up to 20 cm3. The median overall survival of all 46 patients in the study increased by three to four months as compared to the historical control group. The study will continue dose escalation for both infused volume and dose.
"We are excited to share these results that significantly broaden the potential reach of omburtamab, which would be addressing a clear unmet medical need. The results pave the way for our multicenter phase 2 study in DIPG later this year, where we expect to give up to three repeated doses of omburtamab," stated Thomas Gad, founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer, continued, "We are expanding our omburtamab franchise significantly this year. While the iodine labeled omburtamab targets DIPG, CNS/LM from neuroblastoma and DSRCT, we have also initiated clinical trials for medulloblastoma and B7-H3 positive CNS metastasis with our lutetium labeled omburtamab."
Researchers at 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.