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 it will host a virtual research and development day on
Wednesday, December 16, 2020 from 12pm – 2pm Eastern Time.
This webinar will feature presentations from Key
Opinion Leaders (KOLs) Shakeel Modak, M.D., MRCP, Memorial Sloan
Kettering, Jaume Mora, M.D., Ph.D., SJD Barcelona Children's
Hospital, and Brian H. Santich, Ph.D., Memorial Sloan
Kettering.
- Dr. Modak will discuss DANYELZA®
(naxitamab-gqgk) in combination with chemotherapy;
- Dr. Mora will present updated
frontline data for DANYELZA; and
- Dr. Santich will cover the novel
SADA Technology Platform (Liquid RadiationTM) and its potential use
across various tumor types
Additionally, Y-mAbs' management team will also
provide updates on DANYELZA in osteosarcoma, 177Lu-omburtamab-DTPA,
omburtamab’s 101 and Diffuse Intrinsic Pontine Glioma (“DIPG”)
studies, and the Company’s first bispecific antibody nivatrotamab
(GD2xCD3-BsAb) along with a short corporate overview.
Following the formal presentations, Drs. Modak,
Mora, and Santich, as well as the Y-mAbs management team will be
available to answer questions.
To register for the research and development
day, please click here.
Shakeel Modak, M.D., MRCP is a pediatric
Hematology-Oncology doctor at Memorial Sloan Kettering Cancer
Center, Department of Pediatrics in New York, NY. He received his
MBBS and M.D. degrees from TN Medical College, Bombay, as well as
his MRCP degree at Royal College of Physicians, London, UK. Dr.
Modak specializes in the treatment of children and young adults
with neuroblastoma and other solid tumors, such as desmoplastic
small round cell tumors (“DSRCT”). He has been named to Best
Doctors, New York City for the past seven years in a row. Dr. Modak
has been the principal investigator on more than 12 studies
initiated and implemented for neuroblastoma and DSRCT. He has also
been the co-investigator on over 50 clinical studies.
Jaume Mora, M.D., Ph.D. is the scientific
director of the Oncology and Hematology area at SJD Barcelona
Children's Hospital, as well as the director of the Developmental
Tumours Laboratory at SJD Barcelona Children's Hospital. Dr. Mora
is a member of different national and international scientific
societies, including the International Pediatric Oncology Society,
which has awarded him the Schweisguth Prize, and the American
Society of Clinical Oncology (“ASCO”), which in 2000 honored him
with the young investigator award (YIA), as well as the Career
Development Award (“CDA”). In 2011, Dr. Mora was the recipient of
the annual BBVA Foundation Award and in 2006 was awarded the First
Prize from the Spanish Association Against Cancer (“AECC”) for his
work in childhood cancers.
Brian H. Santich, Ph.D. is Research Fellow at
the Nai-Kong Cheung Lab at Memorial Sloan Kettering Cancer Center
and is an experienced PhD scientist with 10 years of training in
antibody engineering, T-cell immunotherapy, targeted radionuclide
therapy and immunology. His work has spanned many diseases
including cancer (neuroblastoma, small-cell lung cancer), viral
infections (HIV, dengue virus), and primary immunodeficiencies
(chronic granulomatous disease). Brian’s research projects have
ranged from antibody discovery campaigns (phage display, yeast
display), humanizations, lead optimization, lab scale manufacturing
and purification, to functional validation (in vitro and in vivo)
and IND-enabling toxicology studies. His work helped facilitated
the successful IND application for nivatrotamab, as well as
spearheaded the development of the novel targeted radionuclide
therapy platform, SADA. Over the past five years, Brian has filed
11 patents and written three first author manuscripts.
Researchers at Memorial Sloan Kettering Cancer
Center (“MSK”) developed DANYELZA, which is exclusively licensed by
MSK to Y-mAbs. As a result of this licensing arrangement, 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 is 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-mAbsY-mAbs is a commercial-stage
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 portfolio and pipeline, including one FDA approved product,
DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2,
and one pivotal-stage product candidate, omburtamab, which targets
B7-H3.
Forward-Looking
StatementsStatements 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; 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,’’
‘‘possibility,’’ ‘‘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 novel coronavirus known
as COVID-19 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.
“DANYELZA” 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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