Y-mAbs Announces Presentation of Naxitamab data at AACR
April 18 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 a poster presentation featuring preclinical data on naxitamab,
a recombinant, humanized anti-GD2 monoclonal antibody will be
presented at the AACR Annual Meeting 2023, which takes place in
Orlando, Florida from April 14-19, 2023. The poster,
“Investigational novel humanized anti-GD2 antibody inhibits
GD2-mediated immunosuppression by targeting GD2+ breast cancer
stem-like cells,” will be presented on April 18, 2023, from 1:30 to
5:00 pm EST.
The disialoganglioside GD2 has been shown to be
upregulated in triple-negative breast cancer (“TNBC”) and its high
expression is associated with a poor prognosis. Furthermore, breast
cancer stem-like cells (“BCSCs”) are reported to be a major
contributing factor for metastatic spread of TNBC and contribute to
chemotherapy resistance, making them an important target for
therapeutic intervention. Currently, there are no available
therapeutic tools for targeting BCSCs. New preclinical data from
M.D. Anderson Cancer Center demonstrate that TNBC with high GD2
expression inhibits immune cell infiltration and that naxitamab
targets GD2+ BCSCs and may be able to inhibit the growth of BCSCs
by enhancing macrophage-mediated phagocytosis, NK cell-mediated
ADCC, and T cell-mediated cytotoxicity.
Y-mAbs provided naxitamab (DANYELZA) to this
pre-clinical investigator sponsored study (“ISS”) at M.D. Anderson
Cancer Center as part of its strategy to continue to support ISS
studies.
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 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, 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 the potential of
naxitamab to target GD2 and BCSCs and inhibit the growth of BCSCs
by enhancing macrophage-mediated phagocytosis, NK cell-mediated
ADCC, and T cell-mediated cytotoxicity, the Company’s product
candidates and pipeline, including with respect to the development
of naxitamab 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’’
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; the
risks that actual results of our restructuring plan and revised
business plan will not be as expected; 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; 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, 2022 filed with the SEC 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.
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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