[Federal Register Volume 83, Number 122 (Monday, June 25, 2018)]
[Notices]
[Pages 29562-29563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13486]


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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 Apexx 
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 10, 2018 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.

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

[[Page 29563]]

within fifteen (15) 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: June 11, 2018.
Christopher P. Austin,
Director, Office of the Director, National Center for Advancing 
Translational Sciences.
[FR Doc. 2018-13486 Filed 6-22-18; 8:45 am]
 BILLING CODE 4140-01-P