E8-4198. Prospective Grant of Exclusive License: The Development of Human Therapeutics for the Treatment of Cancer

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 patent license to practice the inventions embodied in U.S. Patent 5,167,956 entitled “Immunotoxin with in-vivo T-Cell suppressant activity and Methods of Use” [HHS Ref. E-012-1991/0-US-01], U.S. Patent Application 60/037,196 entitled “Novel Vectors and Expression Methods for Producing Mutant Proteins” [HHS Ref. E-043-1997/0-US-01], U.S. Patent Application 60/039,987 entitled “Novel Immunotoxins and Methods of Inducing Immune Tolerance” [HHS Ref. E-044-1997/0-US-01], U.S. Patent Application 09/064,413 entitled “Use of Immunotoxins to Induce Immune Tolerance to Pancreatic Islet Transplantation” [HHS Ref. E-059-1998/0-US-01], U.S. Patent Application 09/291,712 entitled “Methods Related to the Combined Use of Immunotoxins and Agents that Inhibit Dendritic Cell Maturation” [HHS Ref. E-168-1999/0-US-01], and all continuing applications and foreign counterparts, to CK Life Sciences International, Inc., which has offices in Hong Kong. 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: The production and use of the immunotoxins covered by the licensed patent rights for the treatment of T-cell mediated diseases, including but not limited to T-cell lymphoma and autoimmune diseases.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before May 5, 2008 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: David A. Lambertson, Ph.D., Technology Licensing Specialist, 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 invention concerns immunotoxins and methods of using the immunotoxins for the treatment of autoimmune diseases and T cell malignancies. A specific immunotoxin covered by this technology is A-dmDT390-bisFV (UCHT1). The immunotoxins are targeted via an antibody that is specific to T cells, allowing the specific ablation of both malignant T cells and resting T cells. The transient ablation of resting T cells can “reset” the immune system by accentuating tolerating responses to autoimmune diseases like Lupus. Additionally, the immunotoxins can be used to treat T cell related cancers such as non-Hodgkins' lymphomas, including cutaneous T cell lymphoma (CTCL).

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 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 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: February 27, 2008.

Bonny Harbinger,

Deputy Director, Office of Technology Transfer, National Institutes of Health.