[Federal Register Volume 75, Number 137 (Monday, July 19, 2010)]
[Notices]
[Pages 41873-41874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17579]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Development of Human
Therapeutics for the Treatment of Cancer
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
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SUMMARY: This is a notice, in accordance with 35 U.S.C. 209(c)(1) and
37 CFR Part 404.7(a)(1)(i), that 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 US
Patent Application 61/241,620 entitled ``Development of an Immunotoxin
in Which All B-Cell Epitopes Have Been Removed and Which Has High
Cytotoxic Activity'' [HHS Ref. E-269-2009/0-US-01], US Patent
Application 60/969,929 entitled ``Deletions in Domain II of Pseudomonas
Exotoxin A That Reduce Non-Specific Toxicity'' [HHS Ref. E-292-2007/0-
US-01], US Patent Application 60/703,798 entitled ``Mutated Pseudomonas
Exotoxins with Reduced Antigenicity'' [HHS Ref. E-262-2005/0-US-01],
and all continuing applications and foreign counterparts, to MedImmune,
LLC. This license may also include non-exclusive rights to US Patent
Application 60/525,371 entitled ``Mutated Anti-CD22 Antibodies and
Immunoconjugates'' [HHS Ref. E-046-2004/0-US-01], US Patent Application
60/325,360 entitled ``Mutated Anti-CD22 Antibodies with Increased
Affinity to CD22 Expressing Leukemia Cells'' [HHS Ref. E-129-2001/0-US-
01], US Patent Application 60/041,437 entitled ``Recombinant
Immunotoxins Targeted to CD22 Bearing Cells and Tumors'' [HHS Ref. E-
059-1997/0-US-01], US Patent 5,747,654 entitled ``Recombinant
Disulfide-Stabilized Polypeptide Fragments Having Binding Specificity''
[HHS Ref. E-163-1993/0-US-01], PCT application PCT/US96/16327 entitled
``Immunotoxin Containing A Disulfide-Stabilized Antibody Fragment''
[HHS Ref. E-163-1993/2-PCT-01], and all continuing applications and
foreign counterparts. 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 exclusive license territory may be worldwide, and
the field of use may be limited to:
The use of the HA22-LR, HA22-6X, HA22-8X, HA22-LR/6X and HA22-
LR/8X immunotoxins for the treatment of CD22-expressing
hematological malignancies.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
August 3, 2010 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
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; E-mail: [email protected].
SUPPLEMENTARY INFORMATION: These inventions concern immunotoxins and
methods of using the immunotoxins for the treatment of hematological
malignancies such as hairy cell leukemia (HCL), chronic lymphocytic
leukemia (CLL), acute lymphocytic leukemia (ALL) and non-Hodgkin's
lymphoma (NHL). Several specific immunotoxins are covered by this
technology, including HA22-LR, HA22-6X, HA22-8X, HA22-LR/6X and HA22-
LR/8X.
Each of these immunotoxins comprises (1) a toxin moiety that is a
modified version of the Pseudomonas exotoxin A (``PE'') and (2) an
antibody fragment domain that is capable of binding to the CD22 cell
surface receptor. The PE moieties have been modified in various manners
in order reduce the immunogenicity of the molecule. The modifications
improve the therapeutic value of PE while maintaining its ability to
trigger cell death. Since CD22 is preferentially expressed on several
types of hematological cancer cells, the anti-CD22 antibody binding
fragment allows the immunotoxins to be targeted
[[Page 41874]]
selectively to cancer cells so that only the cancer cells are killed.
This results in an effective therapeutic strategy with fewer side
effects due to less non-specific killing of cells.
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR Part
404.7. The prospective 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 404.7 within fifteen (15) days from the date
of this published notice.
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 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: July 13, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-17579 Filed 7-16-10; 8:45 am]
BILLING CODE 4140-01-P