[Federal Register Volume 62, Number 5 (Wednesday, January 8, 1997)]
[Notices]
[Pages 1124-1125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-332]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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    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.

ADDRESSES: 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<SUP>+ 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<SUP>+ T cell responses 
against melanoma. While CD8<SUP>+ T cells are important in the effector 
phase of the immune response, the CD4<SUP>+ helper arm has been shown 
to mediate critical priming and effector functions as well. T cell 
receptors on CD4<SUP>+ 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<SUP>+ 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<SUP>+ 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)
Filed 07 Jun 95
Serial Nos. 08/480,145 and 08/477,389 (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 as 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

[[Page 1125]]

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 June 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 isotopes of ten and 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 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)

    Dated: December 23, 1996.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-332 Filed 1-7-97; 8:45 am]
BILLING CODE 4140-01-M