[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