Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) has resubmitted its Biologics License Application (BLA) for 131I-omburtamab to the FDA as of March 31, 2022. This investigational monoclonal antibody targets B7-H3 in pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The submission is informed by pivotal Phase 2 study results, expected to be published later this year. Y-mAbs aims to meet a critical medical need, as there are currently no effective treatments beyond surgery and radiotherapy for these patients.
- Successful resubmission of the BLA for omburtamab with expected publication of pivotal Phase 2 study results.
- None.
NEW YORK, April 01, 2022 (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 on March 31, 2022, the Company completed the resubmission of its Biologics License Application (“BLA”) for 131I-omburtamab (“omburtamab”) to the FDA.
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.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic cancer products. In addition to conventional antibodies, the Company’s technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform. The Company’s broad and advanced product pipeline includes one FDA-approved product, DANYELZA (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate at the registration-stage, omburtamab, which targets tumors that express B7-H3.
About DANYELZA® (naxitamab-gqgk)
DANYELZA® (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA® includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.
Forward-Looking Statements
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DANYELZA and “Y-mAbs” are registered trademarks of Y-mAbs Therapeutics, Inc.
Contact:
Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
USA
+1 646 885 8505
E-mail: info@ymabs.com
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