- Y-mAbs Therapeutics (NASDAQ:YMAB) announced that the U.S. FDA has cleared the Company’s IND application for 177Lu-omburtamab-DTPA for the treatment of B7-H3 positive CNS and 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.
- 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 Q4 2020.
- Researchers at Memorial Sloan Kettering developed the omburtamab antibody, and as per this licensing arrangement, MSK has institutional financial interests in the compound and in Y-mAbs.
https://seekingalpha.com/news/3625752-y-mabs-announces-fda-clearance-for-lu-omburtamab-dtpa-ind
Monday, October 26, 2020
Y-mAbs announces FDA clearance for lu-omburtamab-DTPA IND
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