Y-mAbs Provides Regulatory Update on Omburtamab
April 20 2021 - 8:00AM
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, today
announced a regulatory update for omburtamab, which is an
investigational, monoclonal antibody that targets B7-H3 and has
been radiolabeled before intraventricular central nervous system
(“CNS”) administration. B7-H3 is an immune checkpoint molecule that
is widely expressed in tumor cells of several cancer types.
Y-mAbs recently concluded a Type B meeting with
the U.S. Food and Drug Administration (“FDA”) regarding omburtamab
and received requests from the FDA for additional data concerning
the granularity of data from our identified historical control
groups. In order to agree on a statistical analysis plan (“SAP”),
this additional granularity data is being collected and we
anticipate submitting it to the FDA by the end of April. An
additional Type B meeting has been scheduled for June 1, 2021 to
discuss the SAP based on review of the additional data. We continue
to be in close dialog with the FDA and maintain our aim of
resubmitting the Biologics License Application (“BLA”) for
omburtamab late in the second quarter or in the third quarter of
2021.
"We believe omburtamab is on track to
potentially become the first FDA approved targeted therapy for
pediatric patients with CNS/leptomeningeal metastasis from
neuroblastoma, addressing an important unmet medical need, where no
standard therapy is currently available," said Thomas Gad, founder,
Chairman and President of Y-mAbs.
Dr. Claus Moller, the Company’s 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 continue
to work closely with the FDA to resubmit the omburtamab BLA. In
addition, we are targeting submission of a Marketing Authorization
Application to the European Medicines Agency on April 30,
2021.”
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 interest related to the compound and
Y-mAbs.
About Y-mAbsY-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
StatementsStatements 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 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
3350New York, NY 10169USA
+1 646 885 8505
E-mail: info@ymabs.com
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