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 clinical update on DANYELZA® (naxitamab-gqgk) for the
treatment of Refractory/Relapsed High-Risk Neuroblastoma was given
at the ESMO Immuno-Oncology Virtual Congress 2020, which is being
held December 9 through December 12, 2020. The DANYELZA data was
presented by Dr. Jaume Mora from SJD Barcelona Children's Hospital,
Spain and Dr. Daniel A. Morgenstern from The Hospital for Sick
Children, Toronto, Canada.
In the Company’s Study 201, a total of 95% of
the infusions were administered in an outpatient setting. The
median infusion time was 37 minutes, and all infusions were
completed in less than 2 hours. The adherence rate was deemed very
satisfactory, as 98% of the infusions were completed as planned,
and the treatments appeared to be generally well tolerated. By
independent review, the overall response rate (“ORR”) in Study 201
was 68% with 59% complete responses (“CR”). In refractory patients,
the ORR was 71% with 64% CR, and in relapsed patients the ORR was
63% with 50% CR.
DANYELZA 40mg/10ml was recently approved by the
U.S. FDA. DANYELZA 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.
DANYELZA is a humanized, monoclonal antibody that targets the
ganglioside GD2, which is highly expressed in various
neuroectoderm-derived tumors and sarcomas. During the Company’s
Study 201, DANYELZA was primarily administered to patients in an
outpatient setting three times in a week and the treatment was
repeated every four weeks.
“I am very pleased to see that 98% of the
infusions were completed as planned and 95% of the infusions were
outpatient. Furthermore, the response rates achieved in these
patients, who were either refractory to frontline treatment or had
relapsed are notable, as this is a difficult to treat patient
population, and the responses are based on antibody treatment
alone, and not combination treatment with chemotherapy,” said
Thomas Gad, founder, Chairman and President.
“We are pleased that Study 201 showed that when
DANYELZA is given in an outpatient setting with a high degree of
treatment adherence, it addressed a significant unmet medical need
in an efficient way. In addition, in Study 201 we saw that the
median infusion time was just over half an hour, and when compared
to the duration of the first infusion, the subsequent infusion
times were generally lower, which we believe is great news for
children living with refractory/relapsed high-risk neuroblastoma,”
said Dr. Claus Moller, Chief Executive Officer.
Researchers at Memorial Sloan Kettering Cancer
Center (“MSK”) developed DANYELZA, which is exclusively licensed by
MSK to Y-mAbs. As a result of this licensing arrangement, 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 under accelerated approval
based on overall response rate and duration of response. Continued
approval for this indication may be 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, anaphylaxis, hypotension,
bronchospasm and stridor and neurotoxicity, such as severe
neuropathic pain, transverse myelitis and reversible posterior
leukoencephalopathy syndrome. See full Prescribing Information 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 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 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 about our business model and
development and commercialization plans; the benefits, safety and
efficacy of DANYELZA, 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,’’ ‘‘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; 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 the novel coronavirus known as 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 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” 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 8505E-mail: info@ymabs.com
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