Y-mAbs Announces Completion of Submission of Omburtamab Biologics License Application to FDA
August 06 2020 - 9:00AM
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
that on August 5, 2020, the Company completed the submission of its
Biologics License Application (“BLA”) under the FDA’s Rolling
Review process for omburtamab. Omburtamab is an investigational,
monoclonal antibody that targets B7-H3, an immune checkpoint
molecule that is widely expressed in tumor cells of several cancer
types. The omburtamab BLA is for the treatment of pediatric
patients with CNS/leptomeningeal metastasis from neuroblastoma. The
submission is based on the safety and efficacy results of the
pivotal Phase 2 studies 101 and 03-133, which the Company expects
to present at a venue later this year.
“I am excited to see the completion of Y-mAbs’
second BLA submission this year in neuroblastoma. As children
treated for high-risk systemic neuroblastoma potentially experience
longer systemic remissions, we expect more patients eventually
relapsing with brain metastasis and there is currently no standard
therapy available for these patients. We believe this is a key
milestone for families facing CNS/leptomeningeal metastasis from
neuroblastoma and for Y-mAbs. As the father of a long-term
high-risk neuroblastoma survivor with CNS/Leptomeningeal
metastasis, I know how important this potentially is for families
faced with brain metastasis from high-risk neuroblastoma,” stated
Thomas Gad, Founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer,
continued, “We believe omburtamab can potentially address a
significant unmet medical need for children with CNS/leptomeningeal
metastasis from neuroblastoma, and we look forward to working with
the FDA to bring omburtamab to appropriate patients. Omburtamab is
also being tested in a Phase 2 study for desmoplastic small round
cell tumor and we are currently planning a Phase 2 study for
diffuse intrinsic pontine glioma, as we believe omburtamab could
potentially be developed for wider compartmental use.”
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,’’
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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 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 3350New York,
NY 10169USA
+1 646 885 8505 E-mail: info@ymabs.com
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