On April 1, 2022 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 on March 31, 2022, the Company completed the resubmission of its Biologics License Application ("BLA") for 131I-omburtamab ("omburtamab") to the FDA (Press release, Y-mAbs Therapeutics, APR 1, 2022, View Source [SID1234611336]).
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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 metastasis from neuroblastoma. The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to publish later this year.
"I am excited to see the completion of Y-mAbs’ second BLA submission in neuroblastoma. As children treated for high-risk systemic neuroblastoma potentially experience longer systemic remissions, we expect more patients eventually relapsing with brain metastasis and there is currently no effective therapy beyond surgery and radiotherapy available for these patients." stated Thomas Gad, Founder, Chairman and President. "As the father of a long-term high-risk neuroblastoma survivor, treated with a predecessor to DANYELZA for systemic high-risk neuroblastoma, and when relapsing with CNS/leptomeningeal metastasis, treated with omburtamab, I know how important this potentially is for families faced with brain metastasis from high-risk neuroblastoma. Y-mAbs was initially founded with the goal of potentially getting both these drugs approved in order to make a major impact on families all over the world."
Dr. Claus Moller, Chief Executive Officer, continued, "We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastasis from neuroblastoma, and we look forward to working with the FDA to bring omburtamab to the appropriate patients. This is a key milestone for families and patients facing CNS/leptomeningeal metastasis from neuroblastoma and for Y-mAbs."
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.