Y-mAbs Announces Update on Omburtamab for DIPG
Y-mAbs Therapeutics (Nasdaq: YMAB) announced interim results from a phase 1 dose-escalation study for omburtamab targeting diffuse intrinsic pontine glioma (DIPG) at the ASCO Virtual Annual Meeting on June 4, 2021. The study demonstrated good tolerability with a median overall survival improvement of 3-4 months over historical controls. The company plans to advance this promising candidate into a phase 2 study later this year, further expanding the omburtamab franchise to include other CNS tumors. The study's positive data marks a significant step in addressing an unmet medical need in cancer treatment.
- Median overall survival increased by 3-4 months compared to historical controls in a study of 46 patients.
- Well-tolerated dosing of omburtamab via convection enhanced delivery.
- Plans for a multicenter phase 2 study in DIPG later this year.
- Expansion of omburtamab franchise to other tumors such as neuroblastoma and medulloblastoma.
- None.
NEW YORK, June 04, 2021 (GLOBE NEWSWIRE) -- 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, today announced 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”) Virtual Annual Meeting on June 4, 2021
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.
About Y-mAbs
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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“DANYELZA” and “Y-mAbs” are registered trademarks of Y-mAbs Therapeutics, Inc.
Contact:
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+1 646 885 8505
E-mail: info@ymabs.com
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