[Federal Register Volume 74, Number 86 (Wednesday, May 6, 2009)]
[Notices]
[Pages 20966-20967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10480]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of 
Therapeutics for Use in Humans To Induce Tolerance for Transplantation 
and To Treat T cell Lymphoma and Leukemia, Autoimmune Diseases Such as 
Lupus, and Graft-Versus-Host Disease

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 
CFR404.7(a)(1)(i), that the National Institutes of Health, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive patent license to practice the inventions embodied in U.S. 
Patent No. 5,167,956 and PCT Application Serial No. PCT/US92/00813 and 
foreign equivalents thereof, entitled ``Immunotoxin with in vivo T cell 
suppressant activity and methods of use'' (HHS Ref. No. E-012-1991/0); 
U.S. Patent No. 5,725,857 and foreign equivalents thereof, entitled 
``Immunotoxin with in vivo T cell suppressant activity and methods of 
use'' (HHS Ref. No. E-012-1991/2); U.S. Patent No. 5,762,927 and 
foreign equivalents thereof, entitled ``Immunotoxin with in vivo T cell 
suppressant activity and methods of use'' (HHS Ref. No. E-012-1991/4); 
Australian Patent No. 762197 and PCT Application Serial No. PCT/US96/
05087 and other foreign equivalents thereof, entitled ``Methods of 
inducing immune tolerance using immunotoxins'' (HHS Ref. No. E-012-
1991/5); U.S. Patent No. 6,103,235 and foreign equivalents thereof and 
U.S. Patent No. 7,125,553 and foreign equivalents thereof, entitled 
``Methods of inducing immune tolerance using immunotoxins'' (HHS Ref. 
No. E-012-1991/7); Australian Patent No. 766692 entitled ``Novel 
vectors and expression methods for producing mutant proteins'' (HHS 
Ref. No. E-043-1997/0); U.S. Patent Application No. 10/566,886 and PCT 
Application No. PCT/US2004/24786 and foreign equivalents thereof 
entitled ``Methods for expression and purification of immunotoxins'' 
(E-043-1997/2); U.S. Patent No. 6,632,928 and PCT Application Serial 
No. PCT/US98/04303 and foreign equivalents thereof, entitled ``Novel 
immunotoxins and methods of inducing immune tolerance'' (HHS Ref. No. 
E-044-1997/0); U.S. Patent Application No. 10/296,085 and PCT 
Application Serial No. PCT/US01/16125 and foreign equivalents thereof 
entitled ``Immunotoxin Fusion Proteins and Means for Expression 
Thereof'' (HHS Ref. No. E-044-1997/1); U.S. Patent No. 7,288,254 and 
PCT Application Serial No. PCT/US99/08606 and foreign equivalents 
thereof entitled ``Use of immunotoxins to induce immune tolerance to 
pancreatic islet transplantation'' (HHS Ref. No. E-059-1998/0); 
Australian Patent No. 781547 and PCT Application No. PCT/US00/10253 and 
other foreign equivalents thereof, entitled ``Methods related to 
combined use of immunotoxins and agents that inhibit dendritic cell 
maturation'' (HHS Ref. No. E-168-1999/0), to Angimmune LLC which is 
located in Bethesda, Maryland. The patent rights in these inventions 
have been assigned to the United States of America.
    The prospective exclusive license territory may be United States, 
Europe, Canada, Australia, Japan, India, Hong Kong, and Brazil and the 
field of use may be limited to the treatment of T cell lymphoma and 
leukemia, autoimmune diseases such as lupus, and complications of 
transplantation, including graft-versus-host disease, and induction of 
tolerance for organ, pancreatic islet, and cell transplantation as 
claimed in the Licensed Patent Rights.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before July 
6, 2009 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Samuel E. Bish, PhD, Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5282; Facsimile: (301) 402-0220; E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The technology describes compositions of 
anti-human, anti-T cell bivalent immunotoxins, methods of producing 
immunotoxins using a genetically-engineered Pichia (yeast) expression 
system, and methods of using the immunotoxin moieties to treat various 
indications, including T cell lymphoma/leukemia, graft-versus-host 
disease (GVHD), and autoimmune diseases such as lupus, and methods to 
use the immunotoxins in combination with immunosuppressants to induce 
tolerance for organ, cell, and pancreatic islet transplants and to 
inhibit dendritic

[[Page 20967]]

cell maturation. The immunotoxins are fusion proteins consisting of a 
truncated diphtheria toxin joined to an anti-CD3 antibody, which binds 
to the CD3 antigen found on the T cell receptor (TCR) of mature T 
lymphocytes (T cells). The toxin moiety acts to kill cells, the anti-
CD3 antibody portion performs cell targeting to direct the toxin to 
specifically kill T cells, and the bivalency allows the immunotoxin to 
bind to target cells with greater efficiency than monovalent 
constructs. Thus, bivalent, anti-CD3 immunotoxins that specifically 
deplete T cells, such as those constructs created by the inventors, 
could yield innovative therapeutics for T cell lymphoma and other 
disorders caused by T cell-related abnormalities.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 
404.7. The prospective exclusive license may be granted unless within 
sixty (60) days from the date of this published notice, 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 part 404.7.
    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: April 28, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-10480 Filed 5-5-09; 8:45 am]
BILLING CODE 4140-01-P