[Federal Register Volume 77, Number 199 (Monday, October 15, 2012)]
[Notices]
[Page 62520]
From the Federal Register Online via the Government Printing 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: lambertsond@mail.nih.gov.

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