[Federal Register Volume 78, Number 130 (Monday, July 8, 2013)]
[Notices]
[Page 40757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16237]



[[Page 40757]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive Commercialization 
License: The Development of a Circularly Permuted IL4-Targeted 
Pseudomonas Exotoxin A (cpIL4-PE38KDEL) for the Treatment of Cancers 
and Urological Disorders

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 
404, indicates that the National Institutes of Health, Department of 
Health and Human Services, is contemplating the grant of a start-up 
exclusive commercialization license to practice the inventions embodied 
in:
    (a) Technology families E-047-1994/0 and E-047-1994/1, including 
U.S. Patent 5,635,599 entitled ``Proteins Comprising Circularly 
Permuted Ligands'' [HHS Ref. E-047-1994/0-US-01], PCT Application PCT/
US95/04468 entitled ``Circularly Permutated Ligands and Circularly 
Permuted Chimeric Molecules'' [HHS Ref. E-047-1994/0-PCT-02], European 
Patent 0754192 entitled ``Proteins Comprising Circularly Permuted 
Ligand'' [HHS Ref. E-047-1994/0-EP-15, validated in Austria, Belgium, 
France, Italy, Liechtenstein, The Netherlands, Spain, Switzerland and 
the United Kingdom], Canadian Patent 2187283 entitled ``Proteins 
Comprising Circularly Permuted Ligands'' [HHS Ref. E-047-1994/0-CA-14], 
Australian Patent 694211 entitled ``Proteins Comprising Circularly 
Permuted Ligands'' [HHS Ref. E-047-1994/0-CA-14], and U.S. Patent 
6,011,002 entitled ``Circularly Permutated Ligands and Circularly 
Permuted Chimeric Molecules'' [HHS Ref. E-047-1994/1-US-01];
    (b) Technology family E-021-2010/0, including U.S. Patent 
Application 61/105,408 entitled ``Targeted Cargo Protein Combination 
Therapy'' [HHS Ref. E-021-2010/0-US-01] and U.S. Patent Application 12/
579,281 entitled ``Targeted Cargo Protein Combination Therapy'' [HHS 
Ref. E-021-2010/0-US-02];
    and all related continuing and foreign patents/patent applications 
for these technology families, to Medicenna Therapeutics, Inc. The 
patent rights in these inventions have been assigned to and/or 
exclusively licensed to the Government of the United States of America.
    The prospective start-up exclusive commercialization license 
territory may be worldwide, and the field of use may be limited to:

    The treatment of cancers and urological disorders that express 
the IL4 receptor on their cell surface by using cpIL4-PE38KDEL.


DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before July 
23, 2013 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated start-up 
exclusive commercialization license should be directed to: David A. 
Lambertson, Ph.D., 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-
4632; Facsimile: (301) 402-0220; Email: [email protected].

SUPPLEMENTARY INFORMATION: Targeted toxins are fusion proteins which 
have been designed to direct therapeutic agents to specific diseased 
cells. Targeted toxins comprise two primary domains: a targeting domain 
and a toxin domain (the therapeutic agent). Diseased cells are targeted 
through the interaction of the targeting domain with a protein that is 
preferentially expressed on the cells. Once targeted to the cells, the 
toxin domain is able to exert its cytotoxic activity and kill the 
specific cell without affecting cells which do not express the target. 
Since there are a number of cell surface proteins that are 
preferentially expressed on diseased cells, targeted toxins are 
potential therapeutic candidates in the treatment of several diseases 
such as cancer and urological disorders.
    The specific targeted toxins for which this start-up exclusive 
license may be granted comprise a targeting domain which contains a 
circularly permuted interleukin 4 (cpIL4) ligand, which binds to the 
IL4 receptor. The IL4 receptor is a cell surface protein that is 
preferentially expressed on several types of cancer cells and cells 
associated with urological disorders. By linking cpIL4 to the 
Pseudomonas extoxin A variant PE38KDEL, it is possible to selectively 
kill the IL4 receptor-expressing cells, leaving non-diseased cells 
alone. This can result in an effective therapeutic strategy with fewer 
side effects than a non-targeted therapy.
    The prospective start-up exclusive commercialization license is 
being considered under the small business initiative launched on 1 
October 2011, and will comply with the terms and conditions of 35 
U.S.C. 209 and 37 CFR Part 404. The prospective start-up exclusive 
license may be granted unless 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 
within fifteen (15) days from the date of this published notice.
    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 start-up exclusive 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.

     Dates: July 1, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-16237 Filed 7-5-13; 8:45 am]
BILLING CODE 4140-01-P