[Federal Register Volume 71, Number 34 (Tuesday, February 21, 2006)]
[Notices]
[Pages 8861-8862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-2362]


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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, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency 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.

Methodology for Large Scale Manufacture of Stable Disulfide-Conjugated 
Antibody-Ribonuclease

David F. Nellis, Dianne L. Newton, Susanna M. Rybak (NCI)
U.S. Provisional Application filed 30 Sep 2005 (HHS Reference No. E-
218-2005/0-US-01)
Licensing Contact: David A. Lambertson; 301/435-4632; 
[email protected]

    Large scale clinical production of disulfide-conjugated antibody-
RNase therapeutics using previously reported technologies usually 
results in an unstable product that forms undesired multimeric 
antibody/RNase species. This invention describes improved methods for 
the large scale manufacture of stable disulfide-conjugated antibody 
therapeutics. Antibody-RNase conjugates produced by this method were 
specific and highly active in vitro in killing selected carcinoma, and 
also showed in vivo activity in the treatment of disseminated B-cell 
lymphoma. These methods are broadly applicable to disulfide-linked 
conjugation of cytotoxic proteins. The claims for this invention 
encompass methods for preparing a protein for disulfide conjugation 
with another molecule, such as an RNase to an antibody.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Identification of Biomarkers by Serum Protein Profiling

Thomas Ried and Jens Habermann (NCI)
U.S. Provisional Application No. 60/664,681 filed 22 Mar 2005 (HHS 
Reference No. E-106-2005/0-US-01)
Licensing Contact: Thomas P. Clouse; 301/435-4076; [email protected]

    This invention describes serum features that distinguish colorectal 
carcinoma malignant patient samples versus healthy samples using 
surface-enhanced laser desorption ionization time-of-flight (SELDI-TOF) 
mass spectrometry. By comparing healthy versus malignant samples, the 
investigators were able to identify thirteen (13) serum features that 
have been validated using an independently collected, blinded 
validation set of 55 sera samples. The features are characterized by 
the mass to charge ratio (m/z ratio). The investigators have shown that 
SELDI-TOF based serum marker protein profiling enables minimally 
invasive detection of colon cancer with 96.7 percent sensitivity and 
100 percent specificity.
    Colorectal cancer is the third most common cancer and the third 
leading cause of cancer-related mortality in the United States. Current 
diagnostic methods for colorectal cancer have a large non-compliance 
rate because of discomfort, e.g., sigmoidoscopy or colonoscopy, or have 
a high rate of false positive results, e.g., fecal occult blood tests. 
The claimed invention has the potential to be a widely used, easy-to-
use, and inexpensive diagnostic.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Novel Form of Interleukin-15, Fc-IL-15, and Methods of Use

Morihiro Watanabe et al. (NCI)
U.S. Provisional Application No. 60/670,862 filed 12 Apr 2005 (HHS 
Reference No. E-296-2004/0-US-01)
Licensing Contact: Thomas P. Clouse, J.D.; 301/435-4076; 
[email protected]

    Interleukin-15 (IL-15) is a potent cytokine that enhances host 
immune system function by proliferating and activating leukocytes. IL-
15 increases innate immunity and CD8 memory. The investigators fused 
IL-15 with protein Fc, a fragment of immunoglobulin. The new fused 
moiety, Fc-IL-15, has a longer half life in vivo than naturally 
occurring IL-15 in a gene therapy setting and has more potent anti-
tumor effects than IL-15 in some mouse tumor models. The new moiety can 
serve as an alternative to IL-15, particularly if long term delivery is 
essential for a therapy. The moiety can serve as a therapeutic for both 
tumors and viral infections. The moiety can include peptide linkers 
such as, for example, a T cell inert sequence or a non-immunogenic 
sequence.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

ELISA Assay of Serum Soluble CD22 To Assess Tumor Burden/Relapse in 
Subjects with Leukemia and Lymphoma

Robert J. Kreitman et al. (NCI)
U.S. Patent Application No. 10/514,910 filed 16 Nov 2004 (HHS Reference 
No. E-065-2002/0-US-03), with priority to 20 May 2002

[[Page 8862]]

Licensing Contact: Jesse Kindra; 301/435-5559; [email protected]

    Disclosed are methods of using previously unknown soluble forms of 
CD22 (sCD22) present in the serum of subjects with B-cell leukemias and 
lymphomas to assess tumor burden in the subjects. Also disclosed are 
methods of diagnosing or prognosing development or progression of a B-
cell lymphoma or leukemia in a subject, including detecting sCD22 in a 
body fluid sample taken or derived from the subject, for instance 
serum. In some embodiments, soluble CD22 levels are quantified. By way 
of example, the B-cell lymphoma or leukemia can be hairy cell leukemia, 
chronic lymphocytic leukemia, or non-Hodgkin's lymphoma. Soluble CD22 
in some embodiments is detected by a specific binding agent, and 
optionally, the specific binding agent can be detectably labeled.
    Also disclosed are methods of selecting a B-cell lymphoma or 
leukemia therapy that include detecting an increase or decrease in 
sCD22 levels in a subject compared to a control, and, if such increase 
or decrease is identified, selecting a treatment to prevent or reduce 
B-cell lymphoma or leukemia or to delay the onset of B-cell lymphoma or 
leukemia.
    Other embodiments are kits for measuring a soluble CD22 level, 
which kits include a specific binding molecule that selectively binds 
to the CD22, e.g. an antibody or antibody fragment that selectively 
binds CD22.
    Further disclosed methods are methods for screening for a compound 
useful in treating, reducing, or preventing B-cell lymphomas or 
leukemias, or development or progression of B-cell lymphomas or 
leukemias, which methods include determining if application of a test 
compound lowers soluble CD22 levels in a subject, and selecting a 
compound that so lowers sCD22 levels.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

    Dated: February 10, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E6-2362 Filed 2-17-06; 8:45 am]
BILLING CODE 4140-01-P