Y-mAbs Announces Presentation of GD2-SADA Study at ASCO
26 Mai 2023 - 3:00PM
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 the design of its Phase 1
clinical trial, evaluating the Company’s Self-Assembly DisAssembly
Pre-targeted Radioimmunotherapy (“SADA Y-PRIT”) Theranostic
Platform for the treatment of certain GD2-positive solid tumors,
including small cell lung cancer, sarcoma and malignant melanoma
will be presented at the American Society of Clinical Oncology
(“ASCO”) Annual Meeting to be held June 2-6, 2023 in Chicago,
Illinois.
The Phase 1 dose-escalation, single-arm,
open-label, non-randomized, multicenter trial (NCT05130255) has
three parts: Part A will explore dose-finding for the GD2-SADA
molecule and testing of dosing intervals between the protein and
the 177Lu-DOTA payload; Part B will determine the optimal dose of
177Lu-DOTA; and Part C will evaluate safety and initial signals of
efficacy using repeated dosing. Dose escalation is based two
patients in cohort 1 and 2, followed by a classical 3+3 design. The
study is actively enrolling, and the Company expects Parts A, B,
and C will include 18, 12, and 32 patients, respectively, across
6-10 U.S. sites.
The GD2-SADA construct was created using the
Company’s SADA Y-PRIT Theranostic Platform, which was licensed by
the Company from Memorial Sloan Kettering Cancer Center (“MSK”) and
Massachusetts Institute of Technology (“MIT”). In research, it was
shown that SADA Y-PRIT utilizes a pre-targeted payload delivery
method where antibody constructs assemble into tetramers and bind
to the tumor target. In prior nonclinical studies, unbound
constructs predictably disassembled into smaller antibody fragments
and were taken up by the liver or excreted through the kidneys
within a few days after administration. In a second infusion, a
radioactive payload designed specifically to target the SADA
molecules attached to the tumor target. Y-mAbs believes this
approach provides the possibility of targeting tumors with
precision while minimizing radiation of normal tissues, and that
the SADA Y-PRIT Theranostic Platform may have the potential to
deliver a variety of payloads and be developed against multiple
tumor targets, as well as for theranostic purposes.
Researchers at MSK developed the SADA technology for
radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs.
MSK has institutional financial interests related to the technology
and Y-mAbs.
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, 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: the SADA technology
platform and expectations with respect to SADA, the potential of
SADA to provide the possibility of targeting tumors with precision
while minimizing radiation of normal tissues, the potential of SADA
to deliver a variety of payloads and be developed against multiple
tumor targets as well as for theragnostic purposes, and the design
of the Phase 1 trial in SADA, including with respect to enrollment
and timing; the Company’s presentation at ASCO; expectations with
respect to our products and product candidates including the
potential of the SADA technology 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’’ 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 Reports 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
Y mAbs Therapeutics (NASDAQ:YMAB)
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