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Government-Owned Inventions; Availability for Licensing

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AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

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 companies and may also be available for licensing.

ADDRESSES:

Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact 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.

Efficient Inhibition of HIV-1 Viral Entry Through a Novel Fusion Protein Including CD4

James Arthos, Claudia Cicala, Anthony Fauci (NIAID)

DHHS Reference No. E-337-01/0 filed 25 Oct 2001

Licensing Contact: Peter Soukas; 301/496-7056 ext. 268; e-mail: soukasp@od.nih.gov

This invention relates to CD4 fusion proteins for use in the treatment of an immunodeficiency virus infection such as human immunodeficiency virus (HIV). These polypeptides have been shown by the inventors to inhibit the entry of primary isolates of HIV-1 into CD4+ T cells by targeting the gp120 subunit of the HIV-1 envelope. The invention claims recombinant polypeptides comprising a CD4 polypeptide ligated at its C-terminus with a portion of a human immunoglobulin comprising a hinge region and two constant domains of an immunoglobulin heavy chain. The portion of the IgG is fused at its C-terminus with a polypeptide comprising a tailpiece from the C terminus of the heavy chain of an IgA antibody. This protein is very large (greater than 800 kilodaltons), which may contribute to its ability to inhibit entry of primary isolates of HIV-1 into T cells. It presents twelve gp120 binding domains (D1D2) and can bind at least ten gp120s simultaneously. The inventors have shown that the construct efficiently neutralizes primary isolates from different HIV subgroups. Also claimed are use of the construct as a component of a vaccine and as a diagnostic.

Methods and Compositions for Production and Purification of Recombinant Staphylococcal Enterotoxin B (rSEB)

Daniel Coffman, Steven Giardina, Jianwei Zhu (NCI)

DHHS Reference No. E-075-01/0 filed 09 Oct 2001

Licensing Contact: Peter Soukas; 301/496-7056 ext. 268; e-mail: soukasp@od.nih.gov

This invention claims processes and compositions for fermentation, recovery, and purification of recombinant bacterial superantigens (rSAgs), exemplified by a recombinant staphylococcal enterotoxin B SEB (rSEB) protein mutated for use in administration to a mammalian recipient. This process generates an economically viable quantity of rSEB vaccine protein meeting FDA parenteral drug specifications. The purification methods generally involve multiple steps including hydrophobic interaction Start Printed Page 2895chromatography (HIC), buffer exchange (desalting), and cation exchange. The final product of the purification is a highly purified rSAg composition satisfying clinical safety criteria and is immunogenic and protective against lethal aerosol challenge in a murine model. The methods and compositions claimed in the patent application provide possible therapeutics and prophylactics for diseases caused by bacterial SAgs, such as food poisoning, bacterial arthritis and other autoimmune disorders, toxic shock syndrome, and the potential use of SAg biowarfare agents.

Novel Peptides to a Melanoma Antigen and Their Use in Diagnostic and Therapeutic Methods

P. Hwu, R. LaPointe, S.A. Rosenberg (NCI)

DHHS Reference No. E-086-01/0 filed 22 Aug 2001

Licensing Contact: Kai Chen; 301/496-7736 ext. 247; e-mail: chenk@od.nih.gov

Various tumor-associated antigens are recognized by T cells, thereby eliciting an immune response. Among these tumor-associated antigens is gp100, which along with several other tumor antigens identified to date is associated with malignant melanoma. Most of the gp100 peptide epitopes identified to date are HLA-A2 (MHC Class I) restricted.

The current invention embodies the identification of a novel HLA-DRB1*0701 (MHC Class II) restricted epitope of gp100. As 16-28% of the population is HLA-DRB1*0701 positive, this peptide could represent a potential immunotherapeutic vaccine for use against melanoma in a significant percentage of the patient population. In addition, the current invention represents only the second gp100 peptide identified to date that is capable of eliciting a CD4+ helper T cell response. It is believed that administration of a peptide capable of eliciting a CD4+ T cell response may be required in order to upregulate a CD8+ T cell response against a Class I-restricted peptide. The identification of an immunogenic Class II-restricted epitope therefore could be of particular importance not only as an immunotherapeutic vaccine in and of itself, but also for use in a vaccination protocol in combination with an immunogenic Class I-restricted peptide.

Tumor Antigen Homologous to Poly(A) Polymerase

S. Topalian (NCI), M. Gonzales (NCI), J. Manley, and S. Kaneko

DHHS Reference No. E-002-01/0 filed 16 May 2001

Licensing Contact: Kai Chen; 301/496-7736 ext. 247; e-mail: chenk@od.nih.gov

Poly(A) polymerase (PAP) activity has long been linked to cancer, and several forms of PAP have been identified to date by various researchers. PAP is an enzyme that is required for the processing and stability of nascent RNA transcripts. The current invention embodies the identification of a new human tumor associated antigen, neo-poly(A) polymerase (neo-PAP), which shares approximately 70% amino acid and 61% nucleic acid sequence similarity with classic PAP.

Neo-PAP is overexpressed in all tumor cell lines tested, including human prostate cancers, colon cancers, and melanomas. It is expressed at low levels in normal human testis tissue as well, but is expressed only at very low levels or not at all in other normal human tissues. Thus, neo-PAP appears to be a “cancer-testis” antigen, which is a category of tumor-associated antigens that are recognized by cytotoxic and helper T lymphocytes as well as serum immunoglobulins. Members of this tumor antigen category, including NY-ESO-1 and MAGE-3, and currently in clinical testing as cancer vaccines. Neo-PAP therefore could represent a potential immunotherapeutic vaccine for use against cancers of various types, and could also be useful in the diagnosis/prognosis of cancer.

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Dated: January 14, 2002.

Jack Spiegel,

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

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[FR Doc. 02-1440 Filed 1-18-02; 8:45 am]

BILLING CODE 4140-01-P