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 publication of naxitamab-based chemoimmunotherapy in patients
with chemoresistant high-risk neuroblastoma (“HR-NB”) in the
journal Cancers.
“The publication in Cancers further validates the utilization of
naxitamab early during the course of treatment for patients with
high-risk neuroblastoma,” said Thomas Gad, Founder, President and
Interim Chief Executive Officer. “In this study, early
administration of naxitamab-based chemo-immunotherapy was shown to
significantly improve long-term outcomes, addressing an important
unmet need in the current treatment paradigm for this critical
patient group.”
Approximately 50% of HR-NB patients are unable to achieve a
complete response (“CR”) or very good partial response (“VGPR”) at
the end of induction (“EOI”) and have poor long term outcomes. This
analysis investigated the combination of humanized anti-GD2 mAb
naxitamab (“Hu3F8”), irinotecan (“I”), temozolomide (“T”), and
sargramostim (“GM-CSF”)—HITS—in patients with HR-NB who did not
achieve a CR/VGPR to induction. Cycles were administered 3-5 weeks
apart and the primary endpoint was overall response rate (CR +
partial response (“PR”)).
Patients who received HITS immediately after induction had
higher response rates (47% vs. 18%) and superior estimated 3-year
overall survival (85% vs. 29%) compared with those who received the
same combination regimen later in the course of treatment. Safety
results showed that the findings were consistent with previous
studies for naxitamab and HITS. The HITS combination did not appear
to exacerbate the rate nor the intensity of infusion-related
toxicities of naxitamab when observed as a stand-alone
treatment.
“These results suggest that the combination of naxitamab and
chemotherapy, when promptly initiated in patients with an
incomplete EOI response, can overcome chemoresistance,” said Dr.
Jaume Mora, the study’s principal investigator at Sant Joan de Déu
Barcelona Children’s Hospital. “By contrast, a profound resistance
may develop in patients administered additional treatment before
receiving HITS, underscoring the need to initiate the
naxitamab-based chemo-immunotherapy as early as possible.”
For more information on this critical development in the
treatment paradigm for patients with high-risk neuroblastoma, the
online publication is available here.
Researchers at Memorial Sloan Kettering Cancer Center (MSK)
developed DANYELZA® (naxitamab-gqgk), which is exclusively licensed
by MSK to Y-mAbs. MSK has institutional financial interests in 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 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-mAbsY-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, OMBLASTYS® (omburtamab), which targets
tumors that express B7-H3.
Forward-Looking
StatementsStatements 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 Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Such statements include, but are not limited
to, statements about our business model, including the Company’s
plans and strategies, development, commercialization and product
distribution plans; expectations with respect to our products and
product candidates, including the potential of DANYELZA and the
potential benefits 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’’, “guidance,” 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
macroeconomic conditions, including the conflict between Russia and
Ukraine and sanctions related thereto, inflation, increased
interest rates, uncertain global credit and capital markets and
disruptions in banking systems; and other risks and uncertainties
affecting the Company including those described in the "Risk
Factors" section included in the Company’s Annual Report on Form
10-K for the fiscal year ending December 31, 2022, the Company’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2023,
the Company’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2023 and future filings and reports by the Company. 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.
Investor Contact:
Courtney DuganVP, Head of Investor Relationscdu@ymabs.com
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