Y-mAbs Announces Initiation of Submission of Omburtamab Rolling Biologics License Application to the FDA
Y-mAbs Therapeutics (YMAB) announced the initiation of its Biologics License Application for omburtamab under the FDA's Rolling Review process. This investigational monoclonal antibody targets B7-H3 in pediatric patients with CNS/leptomeningeal metastases from neuroblastoma. The non-clinical and part of the CMC portions of the BLA were submitted in June 2020, with completion expected in 4-6 weeks. Clinical submission will rely on pivotal Phase 2 studies 101 and 03-133. Omburtamab aims to address significant unmet medical needs for affected children, representing a key milestone for Y-mAbs.
- Initiation of BLA submission for omburtamab under FDA's Rolling Review process.
- Targeting significant unmet medical needs for children with CNS/leptomeningeal metastases from neuroblastoma.
- Omburtamab represents a potential advancement in the treatment of high-risk neuroblastoma.
- None.
NEW YORK, June 30, 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, today announced that the Company has initiated the submission of its Biologics License Application (“BLA”) for omburtamab under the U.S. Food and Drug Administration’s (“FDA”) Rolling Review process. Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma.
The non-clinical portion and a part of the CMC portion of the rolling BLA were submitted during June 2020, and completion of the BLA submission is currently expected to take place over the next four to six weeks. The clinical submission will be based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to present later this year.
“As the father of a long-term high-risk neuroblastoma survivor with CNS/Leptomeningel metastasis, I know how important this potentially is for families faced with brain metastasis from high-risk neuroblastoma and I am excited to see the initiation of Y-mAbs’ second BLA submission this year in neuroblastoma. We believe this is a key milestone for families facing CNS/leptomeningeal metastases from neuroblastoma and for Y-mAbs. We are very grateful to all clinical sites involved in developing omburtamab, and especially to our employees in the development team.” stated Thomas Gad, Founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer, continued, “We look forward to working with the Agency to bring omburtamab to appropriate patients. We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastases from neuroblastoma.”
Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compound and 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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Contact:
Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
USA
+1 646 885 8505
E-mail: info@ymabs.com
FAQ
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