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. Shakeel Modak, MD from Memorial Sloan Kettering (“MSK”)
will present results from the naxitamab-based chemoimmunotherapy
trial in patients with chemoresistant high-risk neuroblastoma
(“HR-NB”), at the American Society of Clinical Oncology (“ASCO”)
Annual Meeting to be held June 3-7, 2022.
This clinical trial studied the combination of
Humanized anti-GD2 antibody naxitamab, Irinotecan, Temozolomide and
Sargramostim (GM-CSF), (“HITS”) protocol, and included cohort of
patients that were treated at MSK in a phase 2 protocol, and at
Hospital Sant Joan de Déu (“HJSD”) per protocol on compassionate
use basis. Health authorities have not established the safety and
efficacy of the HITS protocol, as it is investigational and has not
been approved by health authorities.
Eligibility criteria included evaluable or
measurable chemoresistant disease. Prior anti-GD2 or
irinotecan/temozolomide therapy was permitted. Each cycle,
administered 3-5 weeks apart, comprised irinotecan, temozolomide,
naxitamab and GM-CSF. The primary endpoint of the phase 2 trial at
MSK was complete response (“CR”) and partial response (“PR”) after
4 cycles.
Of 90 previously heavily treated patients, (38
at MSK in the phase 2 trial, and 52 at HJSD), eight had HR-NB
refractory to induction chemotherapy and 82 had up to six prior
relapses.
The primary endpoint was reached in the MSK
phase 2 trial: Objective Response Rate (“ORR”) according to the
International Neuroblastoma Response Criteria (“INRC”) of 30.6 %,
with a lower boundary of 20.4%. In the entire cohort, responses
were 26% for CR, 11% for PR, 9% for mixed response, 27% for stable
disease and 27% for progressing disease (“PD”). In the MSK phase 2
trial, the ORR was 64% for all patients, with soft tissue (48%) and
skeletal MIBG uptake (66%). CR in bone marrow was seen in 57% of
the patients. The ORR in patients with MYCN-amplification was 25%,
in patients with refractory disease 100%, and in patients with
relapsed disease 61%. Moreover, in patients who had previously
received irinotecan/temozolomide or naxitamab, the ORR was 64% and
68%, respectively. In patients who had previously received
dinutuximab/irinotecan/temozolomide, the ORR was 42% (five out of
12 patients).
Toxicities included myelosuppression and
diarrhea as expected with irinotecan/temozolomide, pain and
hypertension as expected with naxitamab, plus febrile neutropenia.
No other >grade 2 unexpected toxicities occurred, and the
treatment was outpatient. In this trial, human anti-human antibody
did not develop in any of the 50 patients providing samples for
testing.
“We are very pleased to present data for the
HITS protocol,” stated Thomas Gad, Founder, President and Interim
CEO. “Responses in patients with relapsed or progressive high-risk
neuroblastoma are challenging, as chemo-resistant disease is
considered an obstacle, so we are excited to see this study met its
primary endpoint. This further demonstrates the potential role for
DANYELZA in HR-NB. No other GD2 antibody has been studied in such a
heavily pre-treated patient population.”
Researchers at Memorial Sloan Kettering Cancer
Center MSK developed naxitamab, which is exclusively licensed by
MSK to Y-mAbs. As a result of this licensing arrangement, MSK has
institutional financial interests in the compound.
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, OMBLASTYS®
(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, commercialization and product distribution plans;
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,’’ “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; 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 coronavirus known as
COVID-19 and its variants such as Delta and Omicron, risks
associated with Russia’s recent invasion of Ukraine 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, 2021 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 3350 New York,
NY 10169 USA
+1 646 885 8505
E-mail: info@ymabs.com
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