Prospective Grant of Exclusive License: The Development of Anti-CD22 Chimeric Antigen Receptors (CARs) for the Treatment of B Cell Malignancies, 62520 [2012-25187]

Download as PDF 62520 Federal Register / Vol. 77, No. 199 / Monday, October 15, 2012 / Notices ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice. 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: SUMMARY: National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Ancillary Studies to Major Ongoing Clinical Research Studies. Date: November 14, 2012. Time: 3:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Lakshmanan Sankaran, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 755, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7799, ls38z@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: October 9, 2012. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2012–25171 Filed 10–12–12; 8:45 am] BILLING CODE 4140–01–P 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. 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. DATES: 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. ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES erowe on DSK2VPTVN1PROD with National Institutes of Health Prospective Grant of Exclusive License: The Development of AntiCD22 Chimeric Antigen Receptors (CARs) for the Treatment of B Cell Malignancies National Institutes of Health, Public Health Service, HHS. AGENCY: VerDate Mar<15>2010 15:21 Oct 12, 2012 Jkt 229001 PO 00000 Frm 00031 Fmt 4703 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 nonHodgkin’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. SUPPLEMENTARY INFORMATION: Sfmt 9990 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 E:\FR\FM\15OCN1.SGM 15OCN1

Agencies

[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.

-----------------------------------------------------------------------

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
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