Y-mAbs Announces Data to be Presented at 2021 ASCO Annual Meeting
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) has announced the acceptance of two poster presentations for DANYELZA and an oral presentation for omburtamab at the American Society of Clinical Oncology Virtual Annual Meeting from June 4-8, 2021. Key topics include the efficacy of naxitamab in high-risk neuroblastoma and a Phase 1 trial of omburtamab for diffuse intrinsic pontine glioma. The collaborations involve researchers from Memorial Sloan Kettering Cancer Center and SJD Barcelona Children's Hospital. Y-mAbs focuses on antibody-based cancer therapeutics, with a pipeline including DANYELZA, which is FDA-approved.
- Acceptance of multiple presentations at a prestigious oncology conference, enhancing visibility.
- DANYELZA is FDA-approved, indicating a validated product in the market.
- Dependence on third-party collaborations for clinical trials and manufacturing, which may impact timelines.
- Potential delays or failures in regulatory submissions could affect product approval and market entry.
NEW YORK, April 29, 2021 (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 is pleased to announce the acceptance of two poster presentations for DANYELZA and an oral presentation for omburtamab at the American Society of Clinical Oncology (“ASCO”) Virtual Annual Meeting, taking place virtually from June 4, 2021 to June 8, 2021. The presentations were submitted by Dr. Brian Kushner, Memorial Sloan Kettering Cancer Center (“MSK”), Dr. Jaume Mora, M.D., Ph.D., SJD Barcelona Children's Hospital and Dr. Mark Souweidane, MSK and Weill Cornell Medicine:
DANYELZA (naxitamab-gqgk)
- Efficacy of naxitamab in patients with refractory/relapse (R/R) high-risk neuroblastoma (HR-NB) by bone/bone marrow (BM) evaluation, potential sites of residual disease (Dr. Kushner)
- Naxitamab and GM-CSF for consolidation of High-Risk neuroblastoma (HR-NB) patients in complete remission (Dr. Mora)
Omburtamab
- Phase 1 dose-escalation trial using convection-enhanced delivery of 124I-omburtamab for diffuse intrinsic pontine glioma following external radiation therapy (Dr. Souweidane)
Researchers at MSK developed DANYELZA and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the products.
About Y-mAbs
Y-mAbs is a commercial-stage 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 one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.
Forward-Looking Statements
Statements in this press release about 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 development, commercialization and product distribution plans; current and future clinical and pre-clinical 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; rate and degree of market acceptance and clinical utility as well as pricing and reimbursement levels; retaining and hiring key employees; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property position and strategy; additional product candidates and technologies; collaborations or strategic partnerships and the potential benefits thereof; expectations related to the use of our cash and cash equivalents, and the need for, timing and amount of any future financing transaction; our financial performance, including our estimates regarding revenues, expenses, capital expenditure requirements; 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,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘targeted,’’ “will”, ‘‘would’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with our financial condition and need for additional capital; risks associated with our development work; cost and success of our product development activities and clinical trials; the risks of delay in the timing of our regulatory submissions or failure to receive approval of our drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of our product candidates; development of our sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for our products; the risks related to our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of our intellectual property rights; risks related to employee matters and managing growth; risks related to our common stock, risks associated with the pandemic caused by the novel coronavirus known as COVID-19 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, and in our other SEC filings. Any 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, future events or otherwise.
“Y-mAbs®” and “DANYELZA®” 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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