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Government-Owned Inventions; Availability for Licensing
Feb 14, 2012 (National Institutes of Health Documents and Publications/ContentWorks via COMTEX) --
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.
Encapsulated N-Acetylmannosamine or N-Acetylneuraminic Acid as a Therapeutic Agent for Increasing Sialylation in Certain Muscular Atrophies, Kidney Disorders, Cancers or Poor Immune Function
Description of Technology: N-acetylmannosamine is a precursor for the synthesis of sugar molecules known as sialic acids, which play an important role in specific biological processes such as cellular adhesion, cellular communication and signal transduction. Lack of sialic acids also plays a crucial role in disease processes such as inflammation, immune responses, as well as certain muscular atrophies (including hereditary inclusion body myopathy (HIBM) and distal myopathy with rimmed vacuoles (DMRV or Nonaka myopathy)), certain kidney disorders with proteinuria and hematuria (including minimal change nephrosis and focal segmental glomerulosclerosis), and certain cancers (including bladder cancer and myeloid leukemia).
This technology relates to methods of administering liposome-encapsulated N-acetylmannosamine, N-acetylneuraminic acid, or their derivatives to treat human disorders of hyposialylation (by increasing sialic acid production in patients who are deficient in that sugar molecule). Liposome-encapsulated delivery of these monosaccharides enhances successful systemic delivery, including to the central nervous system (crossing the blood-brain barrier), and liposome encapsulation protects against gastrointestinal tract degradation.
Potential Commercial Applications:
* Treatment of rare diseases such as HIBM and Nonaka myopathy (or DMRV).
* Treatment of kidney conditions involving sialic acid deficiencies, resulting in proteinuria and hematuria.
* Treatment of other diseases involving sialic acid deficiencies.
* Use as immune stimulant since adequate sialic acid is important for robust immune function.
Competitive Advantages:
* N-acetylmannosamine is the only uncharged sugar in the sialic acid biosynthesis pathway (thus making it easier to deliver than charged sugars) and is located after the rate-limiting step.
* N-acetyl mannosamine and N-acetylneuraminic acid have been shown to rescue hyposialylation in mouse models of HIBM.
* Encapsulated N-acetylmannosamine or N-acetylneuraminic acid crosses the blood-brain barrier and prevents gastrointestinal tract degradation more efficiently than unencapsulated drug.
Development Stage:
* Pre-clinical
* In vitro data available
* In vivo data available (animal)
Inventors: Marjan Huizing et al. (NHGRI).
Publications:
1. Galeano B, et al. Mutation in the key enzyme of sialic acid biosynthesis causes severe glomerular proteinuria and is rescued by N-acetylmannosamine. J Clin Invest. 2007 Jun;117(6):1585-1594. [PMID 17549255]
2. Nemunaitis G, et al. Hereditary inclusion body myopathy: single patient response to intravenous dosing of GNE gene lipoplex. Hum Gene Ther. 2011 Nov;22(11):1331-1341. [PMID 21517694]
3. Kakani S, et al. The Gne M712T mouse as a model for human glomerulopathy. Am J Pathol., in press (Dec 2011) (available online in Feb 2012)
Intellectual Property: HHS Reference No. E-270-2011/0 -- U.S. Application No. 61/531,934 filed 07 Sep 2011.
Licensing Contact: Tara L. Kirby, Ph.D.; 301-435-4426; tarak@mail.nih.gov.
Chimeric Antigen Receptors to CD22 for Treating Hematological Cancers
Description of Technology: Chimeric antigen receptors (CARs) are hybrid proteins consisting of an antibody binding fragment fused to protein signaling domains that cause some T-cells to become cytotoxic. Once activated, these cytotoxic T-cells can selectively eliminate the cells which they recognize. Thus, by engineering a T-cell to express a CAR that is specific for a certain cell surface protein, it is possible to selectively target cells for destruction. This is a promising new therapeutic approach known as adoptive cell therapy.
CD22 is a cell surface protein that is expressed on a large number of B-cell lineage hematological cancers. Several promising therapies are being developed which target CD22, including therapeutic antibodies and immunotoxins. This technology concerns the use of a high affinity antibody binding fragment to CD22 as the targeting moiety of a CAR, adding adoptive cell therapy as a new prospective treatment for certain leukemias and lymphomas.
Potential Commercial Applications:
* Treatment of diseases associated with increased or preferential expression of CD22
* Specific diseases include hematological cancers such as chronic lymphocytic leukemia, hairy cell leukemia and pediatric acute lymphoblastic leukemia
Competitive Advantages:
* Targeted therapy decreases non-specific killing of healthy, essential cells, resulting in fewer non-specific side-effects and healthier patients
* Hematological cancers are susceptible to cytotoxic T-cells for treating because they are present in the bloodstream
* Expression of CD22 only on mature cells allows the avoidance of stem cell elimination during treatment
* High affinity of the antibody binding fragment for CD22 increases the likelihood of successful targeting
Development Stage:
* Pre-clinical
* In vitro data available
* In vivo data available (animal)
Inventors: Rimas J. Orentas et al. (NCI).
Intellectual Property: HHS Reference No. E-265-2011/0-US-01--US provisional application 61/549,516.
Related Technology: HHS Reference No. E-129-2001/0-US-03--US Patent 7,355,012.
Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; lambertsond@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Chimeric Antigen Receptor for CD22, High Affinity. A gene vector to target T cells to B cell leukemia and lymphoma. For collaboration opportunities, please contact John Hewes, Ph.D. at hewesj@mail.nih.gov.
Increased Therapeutic Effectiveness of Immunotoxins That Use Toxin Domains Lacking Both T-Cell and B-Cell Epitopes
Description of Technology: Immunotoxins can kill cancer cells while allowing healthy, essential cells to survive. As a result, patients receiving an immunotoxin are less likely to experience the deleterious side-effects associated with non-discriminate therapies such as chemotherapy or radiation therapy. Unfortunately, the continued administration of immunotoxins often leads to a reduced patient response due to the formation of neutralizing antibodies against immunogenic B-cell and T-cell epitopes contained within PE. To improve the therapeutic effectiveness of PE-containing immunotoxins through multiple rounds of drug administration, NIH inventors have sought to remove the B-cell and T-cell epitopes within PE. Previous work demonstrated that the removal of the major B-cell epitopes from PE reduced the immunogenicity of PE. This technology involves the identification of major T-cell epitopes on PE, and the removal of the primary T-cell epitope by mutation or deletion. By combining the T-cell epitope mutations with modifications that remove B-cell epitopes, it is possible to create PE-based immunotoxins that have even greater resistance to the formation of neutralizing antibodies. Immunotoxins containing these new PE-variants are expected to have improved therapeutic efficacy.
Potential Commercial Applications:
* Essential component of immunotoxins
* Treatment of any disease associated with increased or preferential expression a specific cell surface receptor
* Specific diseases include hematological cancers, lung cancer, ovarian cancer, breast cancer, and head and neck cancers
Competitive Advantages:
* PE variants now include the removal of both B-cell and T-cell epitopes, further reducing the formation of neutralizing antibodies against immunotoxins which contain the PE variants.
* Less immunogenic immunotoxins result in improved therapeutic efficacy by permitting multiple rounds of administration.
* Targeted therapy decreases non-specific killing of healthy, essential cells, resulting in fewer non-specific side-effects and healthier patients.
Development Stage: Pre-clinical.
Inventors: Ira H. Pastan et al. (NCI).
Patent Status:
* HHS Reference No. E-174-2011/0-US-01 -- U.S. Provisional Application 61/495,085.
Related Technologies:
* HHS Reference No. E-269-2009/0-PCT-02 -- PCT Patent Publication WO 2011/032022
* HHS Reference No. E-292-2007/0-US-06 -- US Patent Publication US 20100215656 A1
* HHS Reference No. E-262-2005/0-US-06 -- US Patent Publication US 20090142341 A1
* HHS Reference No. E-139-1999/0-US-07 -- US Patent 7,081,518
* Multiple additional patent families
Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; lambertsond@mail.nih.gov.
Ketamine Metabolites for the Treatment of Depression and Pain
--This is a summary of a Federal Register article originally published on the page number listed below--
Notice.
Citation: "77 FR 8264"
Federal Register Page Number: "8264"
"Notices"
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