Y-mAbs Announces FDA Clearance of IND for its Lutetium-177 Labeled Omburtamab Antibody
October 14 2020 - 9:00AM
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”)
(Nasdaq: YMAB) a late-stage clinical biopharmaceutical company
focused on the development and commercialization of novel,
antibody-based therapeutic products for the treatment of cancer
announced today that the U.S. Food and Drug Administration (“FDA”)
has cleared the Company’s Investigational New Drug (“IND”)
application for 177Lu-omburtamab-DTPA for the treatment of
medulloblastoma, which is the most common type of primary brain
cancer in children. Medulloblastomas are invasive, rapidly growing
tumors that, unlike most brain tumors, spread through the
cerebrospinal fluid and frequently metastasize to different
locations along the surface of the brain and spinal cord.
177Lu-omburtamab-DTPA embodies the Company’s
naked omburtamab antibody radiolabeled with lutetium-177, using
DTPA to chelate the lutetium radioisotope to the antibody.
Lutetium-177 is a beta-emitter with a half-life of 6.7 days and a
maximum energy of 0.5 MeV, corresponding to a maximum soft-tissue
penetration of approximately 1 mm.
We anticipate that an international multicenter
Phase 1/2 clinical trial will be initiated for the screening of
pediatric patients with medulloblastoma during the fourth quarter
of 2020.
“Based on our clinical experience with
131I-omburtamab for B7-H3 positive brain metastasis, we are excited
to see 177Lu-omburtamab-DTPA make its way to the clinic to
establish the safety profile and to determine the maximum tolerated
dose. In this study, we hope to leverage our clinical experience
from treating 27 medulloblastoma patients with 131I-omburtamab,
again using indwelling catheters for intracerebroventricular drug
delivery,” said Thomas Gad, founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer
further notes, “Children with medulloblastoma represent a clear
unmet medical need, and we are very pleased to move this product to
the clinic. In addition, we have submitted a separate IND for a
basket trial in B7-H3 positive CNS/LM cancers in adults to leverage
our experience from treating more than 25 adults with
131I-omburtamab. We expect to initiate the study for the first
adult patients to be treated with 177Lu-omburtamab-DTPA during the
fourth quarter of 2020, and we are genuinely thrilled to widen our
clinical reach to include adult indications.”
Researchers at Memorial Sloan Kettering (“MSK”)
developed the omburtamab antibody, which is exclusively licensed by
MSK to Y-mAbs. As a result of this licensing arrangement, MSK has
institutional financial interests in the compound and in
Y-mAbs.
About
Y-mAbs
Y-mAbs is a late-stage clinical
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 two pivotal-stage product
candidates—naxitamab and omburtamab—which target tumors that
express GD2 and B7-H3, respectively.
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; 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,
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to our competitors and our industry; and other statements that are
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‘‘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 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.
“Y-mAbs” is a registered trademark 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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