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 data for DANYELZA® (naxitamab-gqgk), omburtamab and
nivatrotamab will be presented at the Company’s R&D event,
which takes place virtually today at 12 p.m. Eastern Time. Key
opinion leaders, including Shakeel Modak, M.D., MRCP, Memorial
Sloan Kettering (“MSK”), Jaume Mora, M.D., Ph.D., SJD Barcelona
Children's Hospital, and Brian H. Santich, Ph.D., MSK, will discuss
the current treatment landscape and unmet medical needs for
high-risk neuroblastoma, osteosarcoma and other solid tumors.
Investors, analysts, members of the media and public may access the
event via a live webcast.
DANYELZADr. Mora, who has
experience treating frontline neuroblastoma patients with both
DANYELZA and a competing anti-GD2 antibody, will present clinical
data from both antibodies. Data from an investigator sponsored
frontline study of DANYELZA comprised 73 patients with high-risk
stage 4 neuroblastoma of which 55 patients were in their first
complete remission (“CR”) and 18 patients were in their second CR.
Patients in first CR showed an overall 74.3% event free survival
(“EFS”) at 24 months and an overall survival (“OS”) of 91.6% at 24
months. Patients in second CR showed an overall 38.5% EFS at 24
months and an OS of 88.1% at 24 months.
In osteosarcoma, the Company will present an
update on its ongoing Phase 2 study, which started more than 4
years ago at MSK and has now been approved for recruitment at two
other U.S. sites. A total of 33 patients have received DANYELZA. At
30 months of follow-up the EFS was in excess of 50%.
OmburtamabThe company will also
reconfirm its plan to resubmit its omburtamab BLA for the treatment
of pediatric patients with CNS/leptomeningeal metastasis from
neuroblastoma to the FDA in the beginning of 2021. Preliminary
Overall Survival (“OS”) data for the Company’s multicenter Study
101 for the first 18 months appears supportive of the conclusion
from an earlier Study 03-133 at MSK on survival improvement for
these patients, with 75% of patients surviving after 18 months.
Additionally, the preliminary propensity score analysis of Study
03-133 compared to external control subjects, shows a significant
difference in three years overall survival (p<0.001). Finally,
an independent radiographic evaluation of the tumor responses in
Study 101, shows that for ten evaluable patients with measureable
disease, a total of 40% of the patients responded to omburtamab,
20% with complete response (“CR”) and 20% with partial response
(“PR”), and another five patients had stable disease (“SD”). All
nine patients with response or SD maintained these at six months
follow up.
NivatrotamabThe Company will
also present a status on Study 18-034, covering the first six
cohorts of the study, where patients have received up to 8 μg/kg
per dose. A total of ten patients were enrolled in the study. In
this initial part of the study, no CRs or PRs were achieved, but
the Company is preparing for the Phase 2 studies, including a
separate multicenter study in small cell lung cancer. Future
protocols will be amended to subcutaneous administration, more
frequent dose exposure and, in addition, the premedication regime
will be altered with the objective of being able to further
increase doses of nivatrotamab.
“I am delighted and excited to welcome this
excellent group of key opinion leaders to our R&D event. It
will be a great opportunity to learn more about the clinical
experience of DANYELZA, omburtamab and nivatrotamab, also noting
that SJD Barcelona Children's Hospital, a major pediatric center
located in Barcelona, Spain, has produced promising frontline
DANYELZA data,” said Thomas Gad, founder, Chairman and
President.
Dr. Claus Moller, Chief Executive Officer
further notes, “We are excited to share this broad update on our
pipeline and believe this to be class leading clinical results. The
tumor response data for omburtamab paves the way for the
resubmission of the BLA in early 2021.”
Researchers at MSK developed DANYELZA,
omburtamab and nivatrotamab, which are exclusively licensed by MSK
to Y-mAbs. As a result of this licensing arrangement, MSK has
institutional financial interests related to the compounds and
Y-mAbs.
About DANYELZA®
(naxitamab-gqgk)
DANYELZA 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, anaphylaxis, hypotension, bronchospasm and stridor
and neurotoxicity, such as severe neuropathic pain, transverse
myelitis and reversible posterior leukoencephalopathy syndrome. 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 products for the treatment of cancer.
The Company has a broad and advanced product pipeline, including
one FDA approved product, DANYELZA, which targets tumors that
express GD2, and one pivotal-stage product candidate, 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 our business model and
development and commercialization plans; the benefits, safety and
efficacy of DANYELZA, 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,’’ ‘‘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 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 8505E-mail: info@ymabs.com
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