Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA


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 developing and commercializing novel, antibody-based therapeutics for the treatment of cancer, today announced that on March 31, 2022, the Company finalized 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 widely expressed in tumor cells of several types of cancer. Omburtamab BLA is intended for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma. The submission is based on safety and efficacy results from pivotal Phase 2 studies 101 and 03-133, which the company expects to publish later this year.

“I am delighted to see the completion of the second BLA submission of Y-mAbs in neuroblastoma. As children treated for high-risk systemic neuroblastoma potentially experience longer systemic remissions, we expect more patients eventually relapse with brain metastases and there is currently no effective therapy beyond surgery and radiation therapy available for these patients,” said Thomas Gad, Founder, Chairman and President. “As the father of a long-term survivor of high-risk neuroblastoma, treated with a predecessor of DANYELZA® for high-risk systemic neuroblastoma, and in case of relapse with CNS/leptomeningeal metastases, treated with omburtamab, I know how this is potentially important for families facing high-risk neuroblastoma brain metastases. Y-mAbs was originally founded with the goal of potentially gaining approval for these two drugs to have a major impact on families around the world.

Dr. Claus Moller, CEO, continued: “We believe that omburtamab has the potential to address a significant unmet medical need for children with CNS/leptomeningeal metastases from neuroblastoma, and we look forward to working with the FDA to bring omburtamab to appropriate patients. This is a key milestone for families and patients facing CNS/leptomeningeal metastases due to 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 license agreement, MSK has institutional financial interests in the compound.

About Y-mAbs

Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel antibody-based cancer therapeutics. Besides conventional antibodies, the Company’s technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform. The Company’s extensive pipeline of advanced products includes an FDA-approved product, DANYELZA (naxitamab-gqgk), which targets tumors that express GD2, and a registration-stage product candidate, 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 a relapsed or refractory high-risk disease. neuroblastoma in bone or bone marrow that has demonstrated 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 depend on verification and description of clinical benefit 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 full boxed warning and other important safety information.

Forward-looking statements

Statements in this press release regarding future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our business model and our plans for product development, marketing and distribution; ongoing and future clinical and preclinical studies and our research and development programs; expectations related to the timing of the initiation and completion of regulatory submissions; regulatory, marketing and reimbursement approvals; the rate and degree of market acceptance and clinical utility as well as pricing and reimbursement levels; retaining and hiring key employees; our sales, marketing and manufacturing capabilities and strategy; our intellectual property position and strategy; additional product candidates and technologies; strategic collaborations or partnerships and their potential benefits; expectations related to the use of our cash and cash equivalents, and the need, timing and amount of any future financing transactions; our financial performance, including our estimates of revenues, expenses, capital expenditure needs; developments relating to our competitors and our industry; and other statements that are not historical facts. Words such as ”anticipate” ”believe” ”contemplate” ”continue” ”could” ”estimate” ”expect” ”hope” ”intend ,” ”may” ”could” ”plans” ”potential” ”predicts” ”project” ”should” ”target” ‘will’, ‘would’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. Our product candidates and associated technologies are novel approaches to treating cancer that present significant challenges. Actual results may differ materially from those indicated by these forward-looking statements due to a variety of factors, including, but not limited to: risks associated with our financial condition and our need for additional capital; risks associated with our development work; the cost and success of our product development activities and clinical trials; risks of delays in the timing of our regulatory submissions or failure to obtain approval for our drug candidates; risks associated with the commercialization of any approved pharmaceutical product, including the rate and degree of market acceptance of our product candidates; the development of our sales and marketing capabilities and the risks associated with the inability to obtain sufficient reimbursement for our products; risks related to our dependence on third parties, in particular for the conduct of clinical trials and the manufacture of products; our inability to enter into partnerships; risks relating to governmental regulation; market approval risks; risks associated with protecting our intellectual property rights; risks related to personnel issues and growth management; risks associated with our common stock, risks associated with the pandemic caused by the coronavirus known as COVID-19 and its variants such as Delta and Omicron, risks associated with Russia’s recent invasion of Ukraine and other risks and uncertainties affecting the Company, including those described in the “Risk Factors” section included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the SEC and in our other documents filed with the SEC. All forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, events future or otherwise.

DANYELZA and “Y-mAbs” are registered trademarks of Y-mAbs Therapeutics, Inc.


Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
United States

+1 646 885 8505

Email: [email protected]

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