Y-mAbs Announces Frontline Data for DANYELZA® (naxitamab-gqgk) in High-Risk Neuroblastoma
04 June 2021 - 11:05PM
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 Dr. Jaume Mora, M.D., Ph.D. from SJD Barcelona Children's
Hospital will present frontline data for DANYELZA and GM-CSF for
consolidation of high-risk neuroblastoma (“HR-NB”) patients in
complete remission at the American Society of Clinical Oncology
(“ASCO”) Virtual Annual Meeting on June 4, 2021
Patients received five cycles of DANYELZA and
GM-CSF in a compassionate use setting for consolidation of HR-NB in
first or subsequent complete remission (“CR”). DANYELZA was
administered in an outpatient setting on days 1, 3 and 5 at 9.0
mg/kg/cycle in combination with GM-CSF, and treatment cycles were
repeated every four weeks. From June 2017 to November 2020, a total
of 73 patients were treated: 55 patients (75%) in first CR and 18
patients (25%) in second or more CR. The three-year event free
survival (“EFS”) for patients in first CR was 74% and 19% for
second or later CR. The three-year overall survival (“OS”) for the
patients in first CR was 92% and 66% for second or later CR
patients. Dr. Mora reported two-year EFS and OR at the Company’s
R&D Day in December 2020 and those data have been maintained
for the three-year follow up.
“We are very pleased to report such encouraging
three-year follow-up data in frontline high-risk neuroblastoma for
DANYELZA in patients that are in full remission after the induction
regiment,” stated Thomas Gad, founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer,
continued, “We are excited to see the three-year data holding up so
well for the frontline patients and, if approved, we believe this
could potentially significantly differentiate DANYELZA from other
existing therapies.”
Researchers at MSK developed DANYELZA, which is
exclusively licensed by MSK to Y-mAbs. As a result of this
licensing arrangement, MSK has institutional financial interests in
the product.
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 and anaphylaxis, and
neurotoxicity, such as severe neuropathic pain and transverse
myelitis. 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.
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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
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additional product candidates and technologies; collaborations or
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managing growth; risks related to our common stock, risks
associated with the pandemic caused by the 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 for the year ended December 31, 2020
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” 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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