NIH Invention Disclosures, December 24, 1996

Text of Federal Register notice forwarded for publication by NIH on December 24, 1996

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health

ACTION: Notice

The inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for U.S. companies and may also be available for licensing.

ADDRESS: Licensing information and copies of the U.S. patent applications and issued patents listed below may be obtained by contacting the indicated licensing specialist at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Chimeric GAG Pseudovirions
GJ Tobin, MA Gonda (NCI)
OTT Reference No. E-105-96/0 filed 16 May 96
Licensing Contact: Cindy K. Fuchs, J.D., 301/496-7735 ext 232
This technology is based upon a novel method for generating pseudovirions containing HIV Gag and chimeric Gag-Env fusion proteins that may be used in a prophylactic vaccine or to boost the immune response of HIV-infected individuals. In addition to the foregoing method, the invention provides recombinant chimeric nucleic acids encoding a Gag-frameshift(fs)-fusion partner fusion protein; a pseudovirion comprising a retroviral Gag protein and a fusion partner; an immunogenic composition comprising a pseudovirion; and a Gag-fs-fusion partner fusion protein. Mice inoculated with the pseudovirions developed cytotoxic T lymphocyte responses specific to both HIV Gag and Env epitopes as well as a strong humoral response to Gag. The method allows the packaging of other non-viral proteins such as interleukins, interferons, and other cytokines. (portfolio: Infectious Diseases - Vaccines, viral, AIDS)

MHC Class II-Restricted Melanoma Antigens And Their Use In Therapeutic Methods
SL Topalian, SA Rosenberg, P Robbins (NCI)
Serial No. 08/533,895 filed 26 Sep 95
Licensing Contact: Joseph Contrera, M.S., J.D., 301/496-7056 ext 244
The present invention relates to MHC class II-restricted melanoma antigens and their use in the treatment of human cancers. Cytotoxic CD8+ T cells have been shown to recognize autologous and MHC class I compatible allogenic melanomas expressing shared tumor-associated antigens. Several class I-restricted melanoma-associated antigens have been identified on a molecular level. These antigens and derivative class I-restricted peptides 8 to 10 amino acids in length are being developed as clinical vaccines to stimulate CD8+ T cell responses against melanoma. While CD8+ T cells are important in the effector phase of the immune response, the CD4+ helper arm has been shown to mediate critical priming and effector functions as well. T cell receptors on CD4+ T cells recognize a complex of antigenic peptide in conjunction with MHC class II molecules. Most of these antigenic peptides are 10-34 amino acids in length. Strong and lasting immunity depends, in part, on CD4+ T cell function. Therefore, class II-restricted melanoma antigens may be useful in immunotherapeutic approaches to melanoma.
The present invention relates to MHC class II-restricted melanoma antigens recognized by CD4+ T cells and the nucleic acid sequences that encode them. The invention contains claims to MHC class II immunogenic peptides of tyrosinase and methods of producing an immune response to these peptides. This invention also provides a method for identifying additional class II-restricted melanoma antigens. (portfolio: Cancer - Therapeutics, vaccines; Cancer - Therapeutics, immunomodulators and immunostimulants; Cancer - Therapeutics, biological response modifiers)

eps15, Substrate for the Epidermal Growth Factor Receptor Kinase
PP DiFiore, F Fazioli (NCI)
Serial Nos. 08/480,145 and 08/477,389 filed 07 Jun 95 (both DIV of 08/095,737, now U.S. Patent 5,487,979)
Licensing Contact: Susan Rucker, J.D., 301/496-7056 ext 245
These applications describe eps15, a substrate for the Epidermal Growth Factor Receptor (EGFR). This substrate is distinct from a previously identified substrate for the EGFR known as eps8 (U.S. Patent 5,378,809). EGFR is a cell surface receptor, with tyrosine kinase activity, which has been implicated in mitogenesis via a process known as mitogenic signal transduction. Substrates for the EGFR, such as eps15, may be useful in research on signal transduction involving EGFR, and as diagnostic or prognostic indicators due to their ability to be used in determining the tyrosine kinase activity of tissue sample. In particular, recent work with eps15 fusion proteins has shown that eps15 may be linked to myeloid leukemia due to its translocation. Thus, eps15 may also serve as a tumor marker. In addition to the cDNA, constructs expressing eps15, antibodies to eps15, and methods for assaying eps15 (immunological and DNA based) are described. (portfolio: Research Tools and Reagents, receptors and cell lines; Cancer - Research Reagents)


T-Cell Receptors And Their Use In Therapeutic And Diagnostic Methods
P Hwu, M Nishimura, SA Rosenberg (NCI)
Serial No. 08/411,098 filed 27 Mar 95
Licensing Contact: Joseph Contrera, M.S., J.D., 301/496-7056 ext 244
Tumor infiltrating lymphocytes (TIL) play an important role in tumor regression. TIL cells that recognize a variety of specific tumor antigens have been identified. This invention embodies nucleic acid and amino acid sequences of T-cell receptors which recognize or bind tumor antigens. The claims of this invention relate to the use of these T-cell receptors or hematopoietic stem cells engineered to carry these receptors or chimeric receptors comprised of an antibody variable region joined to the cytoplasmic region of CD28 from a T-cell for therapeutic uses. This application addresses technologies which encompass the broad category of T-cell receptor and chimeric T cell technologies. As such, it is likely that the technologies will have numerous applications in the field of immunotherapy and will potentially be licensable to multiple applicants for a variety of novel therapeutic approaches. (portfolio: Gene-Based Therapies - Therapeutics, delivery systems; Cancer - Therapeutics, immunomodulators and immunostimulants; Cancer - Therapeutics, vaccines; Cancer - Therapeutics, gene therapy, genes)

Process For Producing Monoclonal Antibodies Reactive With Human Breast Cancer
J Schlom, D Colcher, M Nuti, PM Hand, FC Austin (NCI)
Serial No. 06/330,959 filed 15 Dec 81
U.S. Patent No. 4,522,918 issued 11 Jun 85
Licensing Contact: Joseph Contrera, M.S., J.D., 301/496-7056 ext 244
Breast cancer is the second leading cause of cancer death among women, having only recently been surpassed by lung cancer. The incidence rate has remained somewhat steady, and is currently about 108 per 100,000. This invention describes a process to produce antibodies from hybridoma cultures for the detection, prognosis, and treatment of human breast cancer. These eleven antibodies are activated only by tumor cells from human mammary cells and not by apparently normal human tissues. The isotypes of ten of the antibodies are IgG of various subclasses, and one is IgM. The antibodies may be useful in five major areas in the management of human breast cancer: (1) the diagnosis of primary and metastatic breast tumor lesions by assay of human body fluids; (2) the in-situ detection, via gamma scanning, of primary or metastatic breast tumor lesions; (3) the treatment of primary or metastatic breast cancer using one or a combination of the antibodies either alone or coupled with toxic drugs, compounds, or radioactive isotopes; (4) use of the antibodies in the staining of populations of human cells in tissue sections from tumor lesions to indicate the degree of malignancy of the cell populations; and (5) the detection of micro-lesions containing only a few tumor cells that could not be detected by conventional staining techniques. A patent for this invention has been issued by the U.S. Patent and Trademark Office. (portfolio: Cancer - Diagnostics, in vitro, MAb based; Cancer - Research Materials, MAb based)