Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, HHS.

# ACTION:

Notice.

# 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                         *sury.vepa@nih.gov.*                         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                           ( print 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