Y-mAbs Announces Data to be Presented at 2020 SIOP
NEW YORK, July 27, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical 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 five oral presentations at the International Society of Pediatric Oncology (“SIOP”) Virtual Annual Congress held October 14 through October 17, 2020 in Ottawa, Canada. The abstracts are publicly available online at -congress.org/scientific-programme/
Naxitamab
The abstracts include the following presentations of naxitamab, one of the Company’s lead product candidates, which is currently being evaluated for the treatment of pediatric patients with relapsed or refractory high-risk neuroblastoma, osteosarcoma and other GD2-positive tumors:
- “High-dose naxitamab (humanized-3F8) plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor (GM-CSF) for resistant osteomedullary neuroblastoma: major responses and outpatient treatment in a Phase II trial,” submitted by MSK in New York
- “Naxitamab-based chemoimmunotherapy for resistant high-risk neuroblastoma: preliminary results of HITS treatment,” submitted by SJD Barcelona Children's Hospital in Barcelona, Spain
- “Telemedicine blood pressure monitoring after anti-GD2 monoclonal antibody immunotherapy during the COVID-19 pandemic,” submitted by MSK in New York
Naxitamab has been accepted for priority review by the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with relapsed/refractory high-risk neuroblastoma. The FDA set an action date of November 30, 2020, under the Prescription Drug User Fee Act (“PDUFA”).
Omburtamab
The abstracts also include the following presentation of omburtamab, the Company’s other lead product candidate, which is currently being evaluated for the treatment of patients with CNS/Leptomeningeal metastasis from neuroblastoma, diffuse intrinsic pontine glioma (“DIPG”), and desmoplastic small round cell tumors (“DSRCT”):
- “Intracerebroventricular radioimmunotherapy using 131I-omburtamab for neuroblastoma central nervous system/leptomeningeal metastases, interim results from multi-center trial 101,” submitted by Memorial Sloan Kettering Cancer Center (“MSK”) in New York
During June 2020, we initiated the submission of the Biologics License Application (“BLA”) for omburtamab under the FDA’s Rolling Review process and completion of the BLA submission is currently expected to take place over the next few weeks.
GD2-GD3 Vaccine
The abstracts also include the following presentation of the GD2-GD3 Vaccine, the Company’s vaccine candidate, which is currently being evaluated for high-risk neuroblastoma patients in remission:
- “Favorable toxicity profile of bivalent GD2/GD3 neuroblastoma vaccine,” submitted by MSK in New York
About Y-mAbs
Y-mAbs is a late-stage clinical 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 two pivotal-stage product candidates naxitamab and omburtamab—which target tumors that express GD2 and B7-H3, respectively.
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 and commercialization plans; current and future clinical and pre-clinical studies and our research and development programs; 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,’’ “appear,” ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “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 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 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 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.
Contact:
Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
USA
E-mail:
