2013-20057. Prospective Grant of Exclusive License: Development of Brachyury Tumor Associated Antigens as Cancer Vaccines for Colorectal Cancer

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, 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 the following U.S. Patents and Patent Applications to Bavarian Nordic Immunotherapeutics (“BNIT”) located in Mountain View, CA, USA.

Intellectual Property: U.S. Provisional Patent Application No. 61/701,528 [HHS Ref. No. E-054-2011/0-US-01] filed September 17, 2012, entitled “Methods and Compositions for the Treatment of Cancer,” as well as all international applications, continuation applications and divisional applications.

The patent rights in these inventions have been assigned to the government of the United States of America.

The prospective exclusive license territory may be worldwide and the field of use will be limited to the use of Licensed Patent Rights for development of pox virus-based immunotherapeutics for colorectal cancer.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before September 18, 2013 will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Sabarni K. Chatterjee, Ph.D., M.B.A. Licensing and Patenting Manager, Cancer Branch, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Cancer immunotherapy is a recent approach where tumor associated antigens (TAAs), which are primarily expressed in human tumor cells and not expressed or minimally expressed in normal tissues, are employed to generate a tumor-specific immune response. Specifically, these antigens serve as targets for the host immune system and elicit responses that result in tumor destruction.

The technology relates to the development of cancer vaccines utilizing pox virus vectors encoding proteins involved in regulating the epithelial-to-mesenchymal transition (EMT) during vertebrate development, as a cancer antigen. Dr. Jeffrey Schlom et al. at NCI have demonstrated for the first time that a T-box transcription factor and a molecule implicated in EMT, namely the Brachyury protein, appears to be highly expressed in metastasizing tumor cells, and could be a potential target for human T-cell mediated cancer immunotherapy, such as for tumors of the lung, intestine, stomach, kidney, bladder, uterus, ovary, testis, colon and chronic lymphocytic leukemia.

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 thirty (30) 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: August 13, 2013.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.