Y-mAbs Announces Outcome of FDA Advisory Committee Meeting on Omburtamab
October 28 2022 - 3:33PM
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
the outcome of the meeting of the U.S. Food and Drug Administration
(“FDA”) Oncologic Drugs Advisory Committee (“ODAC”), which reviewed
investigational 131I-omburtamab (“omburtamab”) for the treatment of
CNS/leptomeningeal metastasis from neuroblastoma. The committee
voted 16 to 0 that the Company had not provided sufficient evidence
to conclude that omburtamab improves overall survival.
“We are disappointed by the outcome of today’s
meeting, as patients with CNS/leptomeningeal metastasis from
neuroblastoma are in need of effective and safe treatment options,”
said Thomas Gad, President, and Interim Chief Executive Officer.
“Y-mAbs is committed to working closely with the FDA on their
review of the Biologic License Application (“BLA”) for omburtamab
ahead of their decision. We want to thank all of the patients,
caregivers, and healthcare providers who participated in the
studies of this life-threatening condition.”
ODAC reviewed data from omburtamab’s clinical
development program with a focus on study 03-133 (a pivotal phase 1
study) and study 101 (a pivotal phase 2 study) as well as the
historical control group.
Y-mAbs BLA submission for omburtamab was
accepted for Priority Review by the FDA on May 31, 2022, with a
Prescription Drug User Fee Act (“PDUFA”) target date of November
30, 2022. The FDA is not bound by the Advisory Committee’s
recommendations but generally takes the recommendation into
consideration when making its decision.
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 potential approval of omburtamab in the
United States and the timing thereof; 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 and June 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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