Y-mAbs Announces First Patient Dosed in Phase 1 Clinical Trial of GD2-SADA
April 05 2023 - 9:00AM
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 the first patient has been dosed with both the protein dose
and the 177Lu-DOTA imaging dose in its Phase 1 clinical trial,
evaluating the Company’s pre-targeted radioimmunotherapy
Self-Assembly and Disassembly-Bispecific (“SADA”) technology
platform for the treatment of certain GD2-positive solid tumors,
including small cell lung cancer, sarcoma and malignant melanoma.
The two-step approach separating the administration of SADA protein
(“pre-targeting”) from the administration of radioactive ligand is
believed to differentiate SADA constructs from most other
radioimmunotherapy approaches.
“We are excited to advance our SADA platform
into the clinic for the first time with the initiation of patient
dosing in this trial. This is a significant milestone for Y-mAbs in
our efforts to potentially build a global franchise of
radiotherapeutic assets,” said Thomas Gad, Founder, President, and
Interim CEO. “SADA can potentially generate the clinical data to
further unlock the potential of radiolabeled therapeutics in tumors
that have not historically demonstrated meaningful responses.
Further, during the first part of the study, Part A, we plan to
collect imaging data to assess tumor targeting and assess the PK
profile of GD2-SADA, as this could potentially allow for early
evaluation of the program and more informed development
decisions.”
The Phase 1 dose-escalation, single-arm,
open-label, non-randomized, multicenter trial (NCT05130255) targets
malignant melanoma, sarcoma and small cell lung cancer. The trial
will have three parts: Part A will explore dose-finding for the
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 be evaluating safety and initial
signals of efficacy using repeated dosing. The Company expects a
total of approximately 60 patients to be enrolled in the trial
across 6-10 U.S. sites.
The GD2-SADA construct was created using the
Company’s SADA platform, which was licensed by the Company from
Memorial Sloan Kettering Cancer Center (“MSK”) and Massachusetts
Institute of Technology (“MIT”). SADA utilizes a pre-targeted
payload delivery method where antibody constructs assemble in
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. We believe
this approach provides the possibility of targeting tumors with
precision while minimizing radiation of normal tissues. We believe
the SADA platform has the potential to deliver a variety of
payloads and be developed against multiple tumor targets, as well
as for theragnostic purposes.
Researchers at MSK, including Dr. Nai-Kong
Cheung, developed the SADA technology for radioimmunotherapy, which
is exclusively licensed by MSK to Y-mAbs. Dr. Cheung has
intellectual property rights and interests in the technology, and
as a result of this licensing arrangement, and MSK has
institutional financial interests in the technology.
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: the SADA technology
platform and expectations with respect to SADA, including its
potential to be differentiated from most other radioimmunotherapy
approaches and to generate clinical data to unlock the potential of
radiolabeled therapeutics in tumors that have not historically
demonstrated meaningful responses, 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; our
business model, including the Company’s plans and strategies,
development, commercialization and product distribution plans, as
well as our efforts to potentially build a global franchise of
radiotherapeutic assets; 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, 2021, our Quarterly Reports on
Firm 10-Q for the quarters ending March 31, 2022, June 30, 2022 and
September 30, 2022, 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 3350New York,
NY 10169USA
+1 646 885 8505
E-mail: info@ymabs.com
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