03-9286. Prospective Grant of Exclusive License: β2

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license worldwide to practice the inventions embodied in: U.S. Provisional Patent Application 60/088,813, filed June 10, 1998; International Patent Application No. PCT/US99/12309, filed June 3, 1999 (published as WO 9964597A1); and U.S. Patent Application Ser. No. 09/719,243, filed December 7, 2000; to Vaccinex, Inc., having a place of business in Rochester, NY. The United States of America is an assignee to the patent rights of these inventions.

The contemplated exclusive license may be limited to the development of human therapeutics for cancer and other infectious diseases.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before June 16, 2003 will be considered.

ADDRESSES:

Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael A. Shmilovich, J.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]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent application.

SUPPLEMENTARY INFORMATION:

The patent applications cover immunologically active fusion proteins of an immunogenic peptide, β₂ microglobulin or a high affinity mutant of β₂ m, and an optional linker between the first and second domains and/or a single peptide preceding the N-terminal of the first domain. Expressed fusion proteins are cytotoxic CD8⁺ T lymphocyte (CTL) activating and enhance immunogenicity. The fusion proteins, the nucleic acids encoding them, and the cell lines expressing them have broad utility in activating CTLs in response to viral or tumor antigens. The fusion proteins can be used as adjuvants in vaccines that enhance the efficacy of viral or cancer antigen presentation by MHC-1 presenting cells. As a therapeutic, the fusion proteins can be used in vivo or ex vivo to enhance the immunogenicity of cancer cells.

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 60 days from the date of this published Notice, 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.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response 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 7, 2003.

Steven M. Ferguson,

Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer.