E9-10480. 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.

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: [phone]; Facsimile: [phone]; E-mail: [e-mail].

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 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.