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 clinical update for naxitamab and the Company’s SADA
technology programs will be presented at the Company’s R&D
event, which will take place today at 9 a.m. Eastern Time.
Investors, analysts, members of the media and
the public may access the event via a live webcast. The
presentation materials can be found on the Company’s website under
the Presentations tab under the heading For Investors.
The Y-mAbs research and development day will
feature presentations from Thomas Gad, founder, President and
Interim-CEO, Vignesh Rajah, MBBS, DCH, MRCP(UK), MBA, (SVP, Chief
Medical Officer at Y-mAbs), and Steen Lisby, M.D., DMSc, (SVP,
Chief Scientific Officer at Y-mAbs).
SADA Technology
Dr. Lisby will discuss the Company’s SADA
Technology, including announcement of the Company’s first
proprietary hematological SADA construct, CD38-SADA against
Non-Hodgkin’s Lymphoma (“NHL”), and an update on GD2-SADA, which is
being studied in an ongoing Phase 1 clinical trial in adults with
small-cell lung cancer, sarcoma, and malignant melanoma.
DANYELZA®
(naxitamab-gqgk)
Dr. Rajah, will present an update on DANYELZA®
(naxitamab-gqgk), including potential label expansion into
osteosarcoma, and a planned multicenter Phase 2 trial in patients
with newly diagnosed high-risk neuroblastoma.
“We are excited to share these new updates on
both our naxitamab program and the SADA Technology. We believe that
the prospects for the SADA Technology, which combines antibodies
and radioactive payloads, are highly encouraging and could
potentially revolutionize cancer treatments known today. We believe
a CD38-SADA construct will have high potential,” said Thomas Gad,
founder, President and Interim CEO. “We are redoubling our efforts
and refining our focus on DANYELZA® and are pleased to be working
towards advancing the program with a potential label expansion into
osteosarcoma, and a planned multicenter Phase 2 trial in patients
with newly diagnosed high-risk neuroblastoma.”
Researchers at Memorial Sloan Kettering Cancer
Center (“MSK”) developed DANYELZA®, which is exclusively
licensed by MSK to Y-mAbs. MSK has institutional financial
interests related to the compound and Y-mAbs.
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 under accelerated approval
based on overall response rate and duration of response. Continued
approval for this indication may be 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 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 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 potential of the
Company’s products and product candidates, including DANYELZA® and
the SADA Technology, including SADA constructs, and the potential
benefits thereof; the Company’s business plans and prospects;
collaborations or strategic partnerships and the potential benefits
thereof; the Company’s business model and development,
commercialization and product distribution plans; current and
future clinical and pre-clinical studies and our research and
development programs; potential for DANYELZA territory and label
expansion, and advancement of SADA; 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’’
“goal,” “aim,” 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
COVID-19 pandemic; risks associated with the conflict between
Russia and Ukraine and sanctions related thereto, macroeconomic
conditions, 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 filed with the Securities and Exchange Commission
(the “SEC”) and in our other SEC filings, including our Quarterly
Reports on Form 10-Q for the quarters ending March 31, 2022, June
30, 2022, and September 30, 2022 as well as 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
except as required by law.
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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