[Federal Register Volume 82, Number 104 (Thursday, June 1, 2017)]
[Notices]
[Page 25295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11241]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Mutant IDH1 
Inhibitors Useful for Treating Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: National Center for Advancing Translational Sciences, an 
institute of the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an exclusive patent 
license to practice the inventions embodied in the Patent Applications 
listed in the Summary Information section of this notice to GeneXion 
Oncology, Inc., located in New York, NY.

DATES: Only written comments and/or applications for a license which 
are received by the National Center for Advancing Translational 
Sciences on or before July 3, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Sury Vepa, Ph.D., J.D., Senior Licensing and Patenting 
Manager, National Center for Advancing Translational Sciences, NIH, 
9800 Medical Center Drive, Rockville, MD 20850, Phone: 301-217-9197, 
Fax: 301-217-5736, or email [email protected]. A signed Confidential 
Disclosure Agreement may be required to receive copies of the patent 
applications.
    Licensing Availability: The Development of mutant Isocitrate 
Dehydrogenase 1 (mIDH1) inhibitors for the Treatment of Human Cancers.
    Category: Routine.
    Action Needed By: There is no specific date that this needs to be 
approved by, but the sooner the document is approved, the sooner NIH 
can make a potential therapeutic available to the public.
    Summary: Administration of an inhibitor of mIDH1 can potentially 
treat cancers resulting from or characterized by the presence of mIDH1. 
Industrial partners are being sought for licensing and to help further 
develop this technology for use in humans. There are currently few 
effective therapeutics to treat resulting from aberrant activity of 
mIDH1, such as acute myeloid leukemia.
    Justification: Although there is no specific date requirement, 
rapid approval is requested in order to make a potential therapeutic 
available to the public quickly.

SUPPLEMENTARY INFORMATION:

Intellectual Property

1. International Application No. PCT/US15/067406 filed on 12/22/2015 
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating 
Cancer'' (HHS Ref. No: E-243-2014/0-PCT-02), and
2. U.S. Provisional Application No. 62/353298 filed on 06/22/2016 
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating 
Cancer'' (HHS Ref. No. E-189-2016/0-US-01)

    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America 
and the University of North Carolina at Chapel Hill.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the use of Licensed Patent Rights 
for the following: ``Therapeutics for cancers in humans which result 
from or characterized by the presence of mutant IDH1.''
    The inventions relate to a series of novel compounds that potently 
and selectively inhibit mIDH1. These compounds reduce 2-HG levels in 
cell lines in vitro as well as in human cancer cells grown in mouse 
xenografts in vivo. These compounds show greater than 250-fold 
selectivity for the mutant enzyme over the wild-type, show favorable in 
vitro stability (in mouse, rat, dog and human hepatocyte exposure 
studies), are AMES negative, and exhibit no significant metabolic CYP 
liabilities. These compounds possess very favorable in vivo rodent 
pharmacokinetics and bioavailability and are well tolerated in rodents, 
even when dosed at high levels.
    Thus, the compounds of the subject inventions can be used 
individually or in combination to develop new therapies to treat 
diseases which result from mutant IDH1 activity. The diseases caused by 
mutant IDH1 activity include cancer (e.g., acute myeloid leukemia, 
glioma, cholangiocarcinoma and potentially other solid tumors) and 
selected rare diseases, such as Ollier Disease.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
thirty (30) days from the date of this published notice, the National 
Center for Advancing Translational Sciences receives written evidence 
and argument that establishes that the grant of the license would not 
be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 
404.
    Complete applications for a license in the prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Patent License Agreement. 
Comments and objections submitted to this notice will not be made 
available for public inspection and, to the extent permitted by law, 
will not be released under the Freedom of Information Act, 5 U.S.C. 
552.

    Dated: May 25, 2017.
Pamela McInnes,
Deputy Director, Office of the Director, National Center for Advancing 
Translational Sciences.
[FR Doc. 2017-11241 Filed 5-31-17; 8:45 am]
BILLING CODE 4140-01-P