Y-mAbs Announces Presentation of Naxitamab Data at ASCO
26 Maio 2023 - 10:00AM
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 interim
clinical data on naxitamab, a recombinant, humanized anti-GD2
monoclonal antibody, in combination with granulocyte-macrophage
colony-stimulating factor (“GM-CSF”) will be presented at the
American Society of Clinical Oncology (“ASCO”) Annual Meeting to be
held June 2-6, 2023, in Chicago, Illinois.
Patients with high-risk neuroblastoma (“HR-NB”)
commonly develop metastases in the bone and/or bone marrow.
Approximately 15% of HR-NB patients are refractory to induction
therapy and approximately 50% will relapse. The ongoing Phase 2
Trial 201 (NCT03363373) evaluates naxitamab in combination with
granulocyte-macrophage colony-stimulating factor (“GM-CSF”) in
patients with relapsed or refractory HR-NB with residual disease
limited to bone and/or bone marrow. Patients with disease in soft
tissues or actively progressing disease were excluded from the
trial.
Curie Score (“CS”) is a semi-quantitative
scoring system used to assess the extent of bone metastases and
treatment response. Higher CS indicates more extensive bone
involvement and may suggest a poorer prognosis.
An interim analysis of Trial 201 (data cutoff
December 31, 2021) included 52 patients in the efficacy group and
74 patients in the safety group. The efficacy analyses included the
overall response rate (ORR; complete response or partial response)
and the reduction in CS by baseline disease status, i.e.,
refractory or relapsed disease. Clinically meaningful ORRs and
reductions in CS were seen in patients regardless of baseline
disease status. The ORR was 58% in patients with refractory disease
and 42% in patients with relapsed disease. Furthermore, from a mean
baseline CS of 5.5 and 5.7 in the refractory and relapsed subgroups
(range 1-20 across the two subgroups), the mean change to end of
naxitamab treatment was -4.2 and -1.2, respectively. Maximum
reductions in CS for relapsed and refractory subgroups were -17 and
-18, respectively. Overall, the most common naxitamab related
serious adverse events were hypotension, pain, urticaria, and
bronchospasm. Baseline CS did not affect the safety profile of
naxitamab. Patients with refractory disease had a lower frequency
of serious naxitamab related adverse events compared to patients
with relapsed disease.
Naxitamab was licensed by the Company from
Memorial Sloan Kettering (“MSK”). MSK has institutional financial
interests in the compound.
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, 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 treat high-risk neuroblastoma, the safety profile of
naxitamab, expectations with respect to Trial 201, including with
respect to results and timing, the Company’s product candidates and
pipeline, including with respect to the development of naxitamab,
the Company’s presentation at ASCO, 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, our Quarterly Report on Form 10-Q for
the quarter ending March 31, 2023 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:
Courtney DuganVP, Head of Investor RelationsE: cdu@ymabs.comM:
(917) 971-3466
Y-mAbs Therapeutics, Inc. 230 Park Avenue, Suite 3350New York,
NY 10169USA
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