[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