[Federal Register Volume 79, Number 178 (Monday, September 15, 2014)]
[Notices]
[Page 54987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-21855]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Evaluation License: Development of 
Antibody-Drug Conjugates Comprising Topoisomerase Inhibitors for the 
Treatment of Human Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an exclusive license 
to practice the inventions embodied in U.S. Provisional Patent 
Application No. 60/844,027 entitled, ``Azonafide derived tumor and 
cancer targeting compounds,'' filed September 12, 2006 [HHS Ref. No. E-
160-2006/0-US-01], PCT Application No. PCT/US2007/078233 entitled, 
``Azonafide derived tumor and cancer targeting compounds,'' filed 
September 12, 2007 [HHS Ref. No. E-160-2006/0-PCT-02], European Patent 
Application No. 7842310.0 entitled, ``Azonafide derived tumor and 
cancer targeting compounds,'' filed September 12, 2007 [HHS Ref. No. E-
160-2006/0-EP-03], and U.S. Patent Application No. 12/441,029 entitled, 
``Azonafide derived tumor and cancer targeting compounds,'' filed March 
12, 2009 now US Patent No. 8,008,316 issued August 30, 2011 [HHS Ref. 
No. E-160-2006/0-US-04], and all related continuing and foreign 
patents/patent applications for the technology family, to Oncolinx, 
Inc. The patent rights in these inventions have been assigned to the 
Government of the United States of America.
    The prospective exclusive evaluation option license territory may 
be worldwide and the field of use may be limited to the development and 
use of the licensed patent rights as a component of an antibody-drug 
conjugate for the treatment of human cancers. Upon expiration or 
termination of the exclusive evaluation option license, Oncolinx will 
have the right to execute an exclusive patent commercialization license 
which will supersede and replace the exclusive evaluation option 
license with no broader territory than granted in the exclusive 
evaluation option license and the field of use will be commensurate 
with the commercial development plan at the time of conversion.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
September 30, 2014 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments, and other materials relating to the contemplated exclusive 
evaluation option license should be directed to: Jennifer Wong, M.S., 
Senior Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-4633; Facsimile: (301) 
402-0220; Email: [email protected].

SUPPLEMENTARY INFORMATION: The present technology provides compound 
formulation and method of use of improved derivatives of 2-[2'-(2-
aminoethyl)-2-methyl-ethyl]-l,2-dihydro-6-methoxy-3H-dibenz-
[de,h]isoquinoline-l,3-dione (herein referred to as azonafides), 
anthracene-based DNA intercalcators that inhibit tumor growth. The 
synthesized azonafides can be attached to a ligand or antibody to 
recognize specific receptors on cancer cells and delivered as a 
targeted cytotoxic payload. The azonafides have been developed to allow 
for easy modification with different peptide linkers and antibodies, 
but also allow for rapid release once cleaved in lysosomes after 
delivery to the cancer cell enabling highly targeted attack of cancer 
cells. The azonafides have reduced toxicity and lower development of 
drug resistance.
    The prospective exclusive evaluation option license is being 
considered under the small business initiative launched on October 1, 
2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 
37 CFR part 404. The prospective exclusive evaluation option license, 
and a subsequent exclusive patent commercialization license, may be 
granted unless within fifteen (15) days from the date of this published 
notice, the NIH 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.
    Any additional, properly filed, and complete applications for a 
license in the field of use filed in response to this notice will be 
treated as objections to the grant of the contemplated exclusive 
evaluation option license. 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: September 9, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-21855 Filed 9-12-14; 8:45 am]
BILLING CODE 4140-01-P