Y-mAbs Announces Update on Naxitamab and Omburtamab in Neuroblastoma
October 16 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, today announced
clinical updates on naxitamab for the treatment of
relapsed/refractory high-risk neuroblastoma and omburtamab for
CNS/leptomeningeal metastasis from neuroblastoma. Data was
presented at the International Society of Pediatric Oncology
(“SIOP”) Virtual Annual Congress held October 14 through October
17, 2020 in Ottawa, Canada. The naxitamab data was presented by Dr.
Jaume Mora from SJD Barcelona Children's Hospital, and the
omburtamab data was presented by Dr. Kim Kramer from Memorial Sloan
Kettering Cancer Center (“MSK”).
NaxitamabIn a
poster presentation, Dr. Mora presented data from the Company’s
pivotal 201 multicenter study. The central independent evaluation
showed an overall rate of response (“ORR”) of 68% and the rate of
complete response (“CR”) was 59% for the 22 patients. In addition,
bone marrow clearance was observed with complete response in 7 of 9
patients, who had positive bone marrow at trial start. The median
duration of response with long-term follow-up was 27 weeks.
“We are excited to share this new clinical data
for naxitamab, which we believe could be a very important new
treatment for high-risk neuroblastoma patients, if approved.
Naxitamab is administered in an outpatient setting, and the FDA
previously set a PDUFA date of November 30, 2020,” said Thomas Gad,
founder, Chairman and President.
OmburtamabIn an oral
presentation, Dr. Kramer presented planned interim results for 17
patients enrolled on the Company’s pivotal 101 multicenter study.
The study showed a twelve-months overall survival (“OS”) of 87%,
with a median follow-up of 26 weeks. This compares to an OS of
approximately 30% in a historic control group previously disclosed
by the Company.
“The preliminary OS results from the multicenter
Study 101 are encouraging and appears almost identical to the
results of Study 03-133, which was conducted at MSK. While
recruitment is still ongoing, we are very pleased to see the
preliminary omburtamab data in the multicenter setting appearing
supportive of the conclusions from the MSK data. We believe the
preliminary survival curves are very similar to the original MSK
data, and this is good news for children with CNS/leptomeningeal
metastasis from neuroblastoma,” said Claus Moller, Chief Executive
Officer.
Researchers at MSK developed naxitamab and
omburtamab, 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
Y-mAbs
Y-mAbs is a development-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
two pivotal-stage product candidates - naxitamab and omburtamab -
which target tumors that express GD2 and B7-H3, respectively.
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regarding matters that are not historical facts, may constitute
“forward-looking statements” within the meaning of The Private
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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
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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
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technologies are novel approaches to cancer treatment that present
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associated with protection of our intellectual property rights;
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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
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“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 8505E-mail: info@ymabs.com
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