Y-mAbs Announces Update on Omburtamab in DIPG
Y-mAbs Therapeutics announced a clinical update on its treatment, omburtamab, for diffuse intrinsic pontine glioma (DIPG) during the SNO Virtual Annual Meeting. Data from a Phase 1 study indicated that repeated convection enhanced delivery (CED) infusions are feasible in pediatric patients. The study involved seven patients receiving multiple infusions without negatively impacting procedural aspects. Y-mAbs plans a multicenter Phase 2 trial aimed at improving outcomes for DIPG patients.
- Successful presentation of omburtamab data at the Society for Neuro-Oncology meeting.
- Feasibility of repeated CED infusions demonstrated in Phase 1 study.
- Plans for a multicenter Phase 2 study to optimize treatment for DIPG.
- None.
NEW YORK, Nov. 19, 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, today announced a clinical update on omburtamab for the treatment of diffuse intrinsic pontine glioma (“DIPG”). Data was presented at the Society for Neuro-Oncology (“SNO”) Virtual Annual Meeting held November 19 through November 21, 2020. The omburtamab data was presented by Dr. Evan Bander from Weill Cornell Medicine.
In a poster presentation, Dr. Bander presented infusion related data from the ongoing Phase 1 study in DIPG. The study showed the possibility of repeated convection enhanced delivery (“CED”) infusions into the pediatric brainstem. Past CED treatments did not negatively influence the procedural workflow, technical application of the targeted interface, accuracy of catheter placement or distribution capacity. In the study, seven patients underwent two or more sequential CED infusions.
“The potential to retreat DIPG patients with multiple doses of omburtamab is truly exciting. We are planning for a multicenter Phase 2 study in DIPG, and hope to utilize this new insight to optimize the outcome for DIPG patients, who represent a significant unmet medical need,” said Thomas Gad, founder, Chairman and President.
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 and Y-mAbs.
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; 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,’’ ‘‘possibility,’’ ‘‘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 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 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” is a registered trademark 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
FAQ
What recent update did Y-mAbs Therapeutics provide regarding omburtamab?
What is the significance of the Phase 1 study for omburtamab?
When was the data on omburtamab presented?
What are Y-mAbs' plans following the clinical update on omburtamab?
