Y-mAbs and the European Medicines Agency Reach Agreement on the Pediatric Investigation Plan for Naxitamab
February 02 2023 - 9:00AM
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
that the European Medicines Agency (“EMA”) has agreed to the
Company’s proposed Pediatric Investigation Plan (“PIP”) for
naxitamab. The decision follows a positive opinion from EMA’s
Pediatric Committee (“PDCO”). Naxitamab is being developed by
Y-mAbs for the treatment of patients with relapsed/refractory
high-risk neuroblastoma, which is the indication targeted by the
PIP, as well as osteosarcoma.
A PIP outlines a pharmaceutical company’s
strategy for investigation of the new medicinal product in the
pediatric population and is a required submission as part of the
regulatory process for the registration of new medicines in Europe.
An approved PIP is a prerequisite for filing a Marketing
Authorization Application (“MAA”) for any new medicinal product in
Europe.
Researchers at Memorial Sloan Kettering Cancer
Center (“MSK”) developed DANYELZA, which is exclusively
licensed by MSK to Y-mAbs. MSK has institutional financial
interests related to the compound and Y-mAbs.
About DANYELZA®
(naxitamab-gqgk)
DANYELZA® (naxitamab-gqgk) is indicated, in
combination with granulocyte-macrophage colony-stimulating factor
(“GM-CSF”), for the treatment of pediatric patients 1 year of age
and older and adult patients with relapsed or refractory high-risk
neuroblastoma in the bone or bone marrow who have demonstrated a
partial response, minor response, or stable disease to prior
therapy. This indication was approved in the United States by the
FDA under accelerated approval based on overall response rate and
duration of response. Continued approval for this indication is
contingent upon verification and description of clinical benefits
in a confirmatory trial. DANYELZA® includes a Boxed Warning for
serious infusion-related reactions, such as cardiac arrest and
anaphylaxis, and neurotoxicity, such as severe neuropathic pain and
transverse myelitis. See full Prescribing Information
(https://labeling.ymabs.com/danyelza) for complete Boxed Warning
and other important safety information.
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 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® (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, statements with respect to the Company’s
product candidates and pipeline, including with respect to the
development of naxitamab as a potential treatment of patients with
relapsed/refractory high-risk neuroblastoma as well as osteosarcoma
and the related regulatory process, including any potential future
MAA; statements with respect to the benefits of DANYELZA; 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
with the Securities and Exchange Commission (the “SEC”) and in our
other SEC filings, including our Quarterly Reports on Form 10-Q for
the quarters ending March 31, 2022, June 30, 2022 and September 30,
2022 as well as 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 expect 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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