Y-mAbs’ Nivatrotamab for the Treatment of Patients with Neuroblastoma Granted Orphan Drug Designation and Rare Pediatric Di...
October 07 2020 - 9:00AM
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq:
YMAB) a late-stage clinical biopharmaceutical company focused on
the development and commercialization of novel, antibody-based
therapeutic products for the treatment of cancer, today announced
that the FDA has granted Orphan Drug Designation (“ODD”) and Rare
Pediatric Disease Designation (“RPDD”) for its leading bispecific
antibody program nivatrotamab for the treatment of neuroblastoma.
Nivatrotamab, a humanized bispecific anti-GD2
antibody, is currently in Phase 1 clinical development in
collaboration with Memorial Sloan Kettering Cancer Center (“MSK”)
in patients with relapsed/refractory neuroblastoma, as well as high
grade osteosarcoma and other GD2(+) solid tumors, where patients
have relapsed or refractory disease that is resistant to standard
therapy.
“We are very pleased with the ODD granted for
nivatrotamab, as this potentially would give us seven years of
market exclusivity upon market approval. The RPDD makes us eligible
for a Priority Review Voucher (“PRV”) upon potential approval of
the biologics license application for this rare pediatric cancer.
Among our leading compounds, four now have RPDDs, and this
designation further increases our chances of ultimately receiving
multiple PRVs,” said Thomas Gad, Founder, Chairman and
President.
Dr. Claus Moller, Chief Executive Officer,
further notes, “We are very pleased by this recognition by the FDA,
and plan to expand the ongoing study with nivatrotamab into two
separate Phase 2 arms in neuroblastoma and osteosarcoma,
respectively, as well as a separate Phase 2 multicenter study in
small cell lung cancer. We expect to submit an IND for the lung
cancer study during the fourth quarter of 2020, and we are thrilled
to widen nivatrotamab’s clinical reach to include adult
indications.”
Researchers at Memorial Sloan Kettering Cancer
Center (“MSK”) developed nivatrotamab, which is exclusively
licensed by MSK to Y-mAbs. As a result of this licensing
arrangement, MSK has institutional financial interests in the
compound and in Y-mAbs.
About Y-mAbs
Y-mAbs is a late-stage clinical
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 two pivotal-stage product candidates -
naxitamab and omburtamab - which target tumors that express GD2 and
B7-H3, respectively.
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; current and future
clinical and pre-clinical studies and our research and development
programs; 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 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 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.
“Y-mAbs” is a registered trademark 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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