[Federal Register Volume 67, Number 14 (Tuesday, January 22, 2002)]
[Notices]
[Pages 2894-2895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-1440]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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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: 
[email protected]

    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:[email protected]

    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

[[Page 2895]]

chromatography (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: 
[email protected]

    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: 
[email protected]

    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.

    Dated: January 14, 2002.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 02-1440 Filed 1-18-02; 8:45 am]
BILLING CODE 4140-01-P