[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Notices]
[Page 13691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04585]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of m971 
and m972 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 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 61/717,960 entitled ``M971 Chimeric Antigen 
Receptors'' [HHS Ref. E-291-2012/0-US-01], and (b) U.S. Patent 
Application 61/042,239 entitled ``Human Monoclonal Antibodies Specific 
for CD22'' [HHS Ref. E-080-2008/0-US-01], PCT Application PCT/US2009/
124109 entitled ``Human and Improved Murine Monoclonal Antibodies 
Against CD22'' [HHS Ref. E-080-2008/0-PCT-02], US patent application 
12/934,214 entitled ``Human Monoclonal Antibodies Specific for CD22 '' 
[HHS Ref. E-080-2008/0-US-03], 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 m971 or 
m972 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 
April 1, 2013 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 m971 and m972. 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: February 22, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-04585 Filed 2-27-13; 8:45 am]
BILLING CODE 4140-01-P