Y-mAbs Announces Complete Response Letter for Omburtamab Biologics License Application
December 01 2022 - 5:34PM
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
that the U.S. Food and Drug Administration (“FDA”) has issued a
complete response letter (“CRL”) for the Biologics License
Application (“BLA”) for the investigational medicine
131I-omburtamab (“omburtamab”) for the treatment of
CNS/leptomeningeal metastasis from neuroblastoma.
The letter indicates that the FDA completed the
review of the application and determined that it is unable to
approve the BLA in its current form. This is consistent with the
outcome of the Oncologic Drugs Advisory Committee Meeting in
October. The CRL includes a recommendation for meeting with the
agency to discuss adequate and well-controlled trial design to
demonstrate substantial evidence of effectiveness and a favorable
benefit-risk profile.
Y-mAbs is assessing the implications of the CRL
and its plans for the omburtamab program.
“We are disappointed by the CRL but not
surprised based on the outcome of the ODAC meeting on October 28.
We want to express our gratitude to all the patients, their
families, and investigators who have participated in our clinical
trials and advocated for the advancement of omburtamab,” said
Thomas Gad, President, and Interim Chief Executive Officer. “While
we evaluate the implications of the CRL for the future of
omburtamab, we are excited about refining our focus primarily to
drive growth from DANYELZA and validate our SADA platform in the
clinic, with the goal of bringing innovative solutions to patients
and value to our shareholders.
Researchers at MSK developed omburtamab, which
is exclusively licensed by MSK to Y-mAbs. As a result of this
licensing arrangement, MSK has institutional financial interests in
the compound.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical
company focused on the development and commercialization of novel,
antibody-based therapeutic cancer products. In addition to
conventional antibodies, the Company’s technologies include
bispecific antibodies generated using the Y-BiClone platform and
the SADA platform. The Company’s broad and advanced product
pipeline includes one FDA-approved product, DANYELZA®
(naxitamab-gqgk), which targets tumors that express GD2, and one
product candidate at the registration-stage, OMBLASTYS®
(131I-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 our expectations with respect to the
omburtamab program; our expectations with respect to increasing
efforts and refining focus on DANYELZA®, our SADA platform, and the
rest of our pipeline; our goal of bringing innovative solutions to
patients and value to our shareholders; 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,’’ ‘‘target,’’
“will”, ‘‘would’’, “goal,” “aim,” 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 COVID-19 pandemic, risks associated with the
conflict between Russia and Ukraine and sanctions related thereto,
macroeconomic conditions, including inflation and uncertain global
credit and capital markets; 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, 2021, our Quarterly Reports on Form 10-Q
for the quarters ended March 31, 2022, June 30, 2022, and September
30, 2022 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 except as required by law.
DANYELZA®, OMBLASTYS® and Y-mAbs® 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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