[Federal Register Volume 77, Number 199 (Monday, October 15, 2012)]
[Notices]
[Page 62520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-25187]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Development of Anti-
CD22 Chimeric Antigen Receptors (CARs) for the Treatment of B Cell
Malignancies
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
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SUMMARY: This is 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 license to practice the inventions embodied in (a) U.S.
Patent Application 61/549,516 entitled ``Anti-CD22 Chimeric Antigen
Receptors'' [HHS Ref. E-265-2011/0-US-01], and (b) U.S. Patent
Application 60/325,360 [HHS Ref. E-129-2001/0-US-01], PCT Application
PCT/US02/30316 [HHS Ref. E-129-2001/0-PCT-02], U.S. Patent 7,355,012
[HHS Ref. E-129-2001/0-US-03], European Patent 1448584 [HHS Ref. E-129-
2001/0-EP-04] (validated in Germany, Spain, France, The United Kingdom
and Italy [HHS Ref. E-129-2001/0-IT-12], Australian Patent 2002327053
[HHS Ref. E-129-2001/0-AU-05], Canadian Patent Application 2461351 [HHS
Ref. E-129-2001/0-CA-06], U.S. Patent 7,777,019 [HHS Ref. E-129-2001/0-
US-07], U.S. Patent Application 12/846,625 [HHS Ref. E-129-2001/0-US-
13], U.S. Patent Application 13/438,725 [HHS Ref. E-129-2001/0-US-14]
(all entitled ``Mutated Anti-CD22 Antibodies with Increased Affinity to
CD22 Expressing Leukemia Cells''), and all related continuing and
foreign patents/patent applications for these technology families, to
Neomune, 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 exclusive license territory may be worldwide, and
the field of use may be limited to:
Treatment of B cell malignancies that express CD22 on their cell
surface using chimeric antigen receptors which contain the HA22 or
BL22 antibody binding fragments.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
November 14, 2012 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
evaluation option 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: Chimeric antigen receptors (CARs) are
engineered cell surface receptors which have been designed to target
immune effector cells (such as a T cell) to certain cellular targets.
CARs target diseased cells through antigen-specificity domain
recognizes a protein that is preferentially expressed on the cells, and
the immune effector cell proceeds to eradicate the diseased cells.
Since there are a number of cell surface proteins that are
preferentially expressed on cancer cells, CARs are potential
therapeutic candidates in the treatment of cancer.
The specific CARs for which this exclusive license may be granted
comprise a targeting domain which contains the antibody binding
fragments of the anti-CD22 antibodies HA22 and BL22. CD22 is a cell
surface protein that is preferentially expressed on several types of
cancer cells, including hematological malignancies such as chronic
lymphocytic leukemia (CLL), acute lymphocytic leukemia (ALL), hairy
cell leukemia (HCL) and non-Hodgkin's lymphoma (NHL). By linking an
anti-CD22 antibody binding fragment to a CAR, it is possible to
selectively kill the CD22-expressing cancer cells, leaving non-cancer
cells alone. This results in an effective therapeutic strategy with
fewer side effects than a non-targeted therapy.
The prospective exclusive license will comply with the terms and
conditions of 35 U.S.C. 209 and 37 CFR 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 404.7
within thirty (30) 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 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: October 9, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-25187 Filed 10-12-12; 8:45 am]
BILLING CODE 4140-01-P