Burtomab Receives Breakthrough Therapy Designation for Advanced Form of Pediatric Cancer

NEW YORK–(BUSINESS WIRE)– Burtomab, a drug for metastatic neuroblastoma, created by Memorial
Sloan Kettering Cancer Center (MSK) and licensed to Y-mAbs
Therapeutics, Inc. (YmAbs), has been granted Breakthrough Therapy
Designation by the FDA for the treatment of pediatric patients with
relapsed or refractory neuroblastoma with central nervous system or
leptomeningeal metastasis. MSK’s Nai-Kong
Cheung, MD, PhD, created and tested the antibody that resulted in
the breakthrough therapy designation.

Breakthrough Therapy Designation is a program intended to expedite the
development and review of drugs to treat serious or life-threatening
diseases in cases where preliminary clinical evidence shows that the
drug may provide substantial improvements over available therapy. The
Breakthrough Therapy Designation for burtomab was granted on the basis
of data from a pivotal clinical study of burtomab with radiolabeled
iodine (¹³¹I) for the treatment of neuroblastoma that
metastasize to the central nervous system or the leptomeninges.

“Currently there are no approved drugs to treat this type of advanced
neuroblastoma,” said Dr. Cheung who has spent decades conducting
pioneering research in developing treatments for neuroblastoma. “MSK
treats more patients with neuroblastoma than any other institution in
the world, and with evidence-based treatment approaches like this, we
can offer real hope for better treatments to patients and families
confronting this devastating disease.”

YmAbs Founder, President and Head of Business Development and Strategy,
Thomas Gad said, “We are very pleased that the FDA has granted the
Breakthrough Therapy Designation to burtomab and thereby shortened the
timelines for making this therapy available to the children facing an
unmet medical need. Burtomab clearly provides a potential curative
treatment option for pediatric patients otherwise faced with little or
no options. This is an important milestone achievement for YmAbs, and we
continue to work with our strategic partner MSK and the regulatory
authorities to advance burtomab to patients suffering from refractory
leptomeningeal metastasis from neuroblastoma as quickly as possible.”

Dr. Claus Møller, Chief Executive Officer further notes, “This is the
first time burtomab has earned the distinction of a Breakthrough Therapy
Designation. We are pleased that the FDA continues to recognize the
potential of burtomab to help patients with neuroblastoma that
metastasize to the central nervous system or the leptomeninges.”

About Breakthrough Therapy Designation:

The Breakthrough Therapy Designation was enacted as part of the 2012 FDA
Safety and Innovation Act (FDASIA) and is intended to expedite
development of drugs to treat serious and life-threatening medical
conditions when preliminary clinical evidence demonstrates that the drug
may have substantial improvement on at least one clinically significant
endpoint over available therapies. Breakthrough Therapy Designation
includes all the features of the Fast Track Designation, as well as more
intensive guidance from the FDA on a drug’s clinical development program.

About YmAbs:

YmAbs is a clinical stage biopharmaceutical company focused on
developing new cancer treatments through immunotherapies. In addition,
YmAbs utilizes its platform technologies to create next-generation
humanized, affinity matured bispecific antibodies targeting GD2 and
B7H3. To further improve our bispecific antibodies, we are collaborating
with MSK on the development of a novel human protein tag that dimerizes
T-cell engaging bispecific antibodies, which enables higher tumor
binding and results in a longer serum half-life and a significantly
greater T-cell mediated killing of tumor cells. Our treatments could
potentially reduce longer-term toxicities associated with current
chemotherapeutics and provide the potential for curative therapy even
for patients with widespread disease. YmAbs’ goal is to drive multiple
product candidates in select solid tumor cancers to FDA licensure. Each
candidate has the potential to treat a variety of high-risk cancers.

To learn more, visit www.ymabs.com.

About Memorial Sloan Kettering

We are the world’s oldest and largest private cancer center, home to
more than 15,000 physicians, scientists, nurses, and staff united by a
relentless dedication to conquering cancer. As an independent
institution, we combine 130 years of research and clinical leadership
with the freedom to provide highly individualized, exceptional care to
each patient. And our always-evolving educational programs continue to
train new leaders in the field, here and around the world. For more
information, go to www.mskcc.org.

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