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NEW YORK, Oct. 7, 2021 (GLOBE NEWSWIRE) – Y-mAbs Therapeutics, Inc. (“Y-mAbs†or the “Companyâ€) (NASDAQ: YMAB), a commercial-stage biopharmaceutical company focused on development and commercialization new antibody-based therapeutics for the treatment of cancer, today announced that the United States Food and Drug Administration (“FDAâ€) has granted Rare Pediatric Disease (“RPDDâ€) designation for The Company’s lutetium-labeled omburtamab antibody program for the treatment of medulloblastoma.
177Lu-omburtamab-DTPA, a B7-H3 monoclonal antibody that has been radiolabeled with lutetium-177, is currently in a phase 1, multicenter clinical trial in pediatric patients with refractory medulloblastoma, and in a clinical trial Phase 1 multicenter targeting B7-H3 positive CNS / LM tumors in adults. We believe that both indications address clearly unmet medical needs.
“The RPDD makes us eligible for a Priority Review Voucher (‘PRV’) upon potential approval of the biologics license application for this rare pediatric cancer. Of our flagship compounds under development, four now have RPDDs, and this designation for 177Lu-omburtamab-DTPA further increases our chances of receiving multiple PRVs over time, â€said Thomas Gad, Founder, President and Chairman.
Dr Claus Moller, Chairman and CEO, adds: “We are committed to providing 177Lu-omburtamab-DTPA for patients in desperate need of alternative methods of treatment. We are very pleased with this recognition by the FDA and look forward to expanding the ongoing Phase 1 studies with 177Lu-omburtamab-DTPA in separate phase 2 arms.
Researchers at Memorial Sloan Kettering Cancer Center (“MSKâ€) developed omburtamab, which is exclusively licensed by MSK at Y-mAbs. As a result of this license agreement, 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 therapeutics for the treatment of cancer. The Company has a broad portfolio of advanced products, including an FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and a pivotal stage candidate, omburtamab, which targets tumors that express B7-H3.
Forward-looking statements
Statements in this press release regarding future expectations, plans and prospects, as well as any other statements regarding matters which are not historical facts, may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act. from 1995. These statements include, but are not limited to, statements about our business model and our product development, marketing and distribution plans; current and future clinical and preclinical studies and our research and development programs; expectations related to the timing of initiation and completion of regulatory submissions; regulatory, marketing and reimbursement approvals; rate and degree of market acceptance and clinical utility as well as price and reimbursement levels; retain and hire key employees; our marketing, marketing and manufacturing capabilities and strategy; our position and strategy on intellectual property; 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 necessity, timing and amount of any future financing transaction; our financial performance, including our estimates of income, expenses, capital expenditure requirements; developments relating to our competitors and our industry; and other statements which are not historical facts. Words such as ” anticipate, ” ” believe, ” “contemplate”, ” continue ”, ” might, ” ” estimate, ” ” expect, ” “hope” , ” intend, ” ” may, ” ” could, ” ” plan, ” ” potential, ” ” predict, ” ” project, ” ” should, ” ” target, ” “will”, “‘” and similar phrases are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and associated technologies are new approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by these forward-looking statements due to various factors, including, but not limited to: risks associated with our financial condition and the need for additional capital; risks associated with our development work; the cost and success of our product development and clinical trial activities; risks of delays in the timing of our regulatory submissions or of not obtaining 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 associated with our reliance on third parties, including for the conduct of clinical trials and the manufacture of products; our inability to enter into partnerships; risks associated with government regulations; risks associated with market approval; risks associated with protecting our intellectual property rights; risks associated with employee issues and growth management; risks associated with our common stocks, risks associated with the pandemic caused by the coronavirus known as COVID-19, including the emergence of variants such as the Delta variant, 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 year ended December 31, 2020 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 assumes no obligation to update any forward-looking statements, whether as a result of new information, events future or otherwise.
“DANYELZA†and “Y-mAbs†are registered trademarks of Y-mAbs Therapeutics, Inc.
Contact:
Y-mAbs Therapeutics, Inc.
230, avenue du Parc, office 3350
New York, New York 10169
United States
+1 646 885 8505
Email: [email protected]
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