Government-Owned Inventions; Availability for Licensing, 8264-8266 [2012-3412]

Download as PDF 8264 Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES using the immunotoxins for the treatment of mesothelin-expressing cancers (such as mesothelioma, ovarian cancer and pancreatic cancer). The specific immunotoxin will have an antibody targeting domain that contains the CDRs of the antibody identified as SS1, which was invented at the NIH. The specific immunotoxin will also have a toxin domain derived from PE that is resistant to lysosomal proteases due to the deletion of a large portion of the exotoxin, and which lacks at least one major B-cell epitope due to the alteration an amino acid. Ultimately, the PE used in the immunotoxin may lack multiple B-cell epitopes, as well as multiple T-cell epitopes, in an effort to minimize immunogenicity. Alterations to the toxin that reduce immunogenicity improve the therapeutic value of the immunotoxin while maintaining its ability to trigger cell death. Since mesothelin is preferentially expressed on certain types of cancer cells, the immunotoxins selectively bind and kill only those cancer cells, allowing healthy, essential cells to remain unharmed. This results in an effective therapeutic strategy with fewer side effects. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR Part 404.7. The prospective exclusive license may be granted unless the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR Part 404.7 within thirty (30) days from the date of this published notice. Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: February 8, 2012. Richard U. Rodriguez, Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2012–3410 Filed 2–13–12; 8:45 am] BILLING CODE 4140–01–P VerDate Mar<15>2010 21:57 Feb 13, 2012 Jkt 226001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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. SUMMARY: 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: Nacetylmannosamine 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 Nacetylmannosamine, Nacetylneuraminic acid, or their derivatives to treat human disorders of PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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 Nacetylneuraminic acid have been shown to rescue hyposialylation in mouse models of HIBM. • Encapsulated Nacetylmannosamine or Nacetylneuraminic 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 Nacetylmannosamine. 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. E:\FR\FM\14FEN1.SGM 14FEN1 Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES 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 Tcells 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 nonspecific 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. VerDate Mar<15>2010 21:57 Feb 13, 2012 Jkt 226001 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 sideeffects 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 PEcontaining 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 PEvariants 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: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 8265 • 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 nonspecific 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 Description of Technology: The market continues to have a need for therapeutics for treating pain and depression that have efficacy in a high percentage of patients but have reduced anaesthetic properties and reduced abuse liability. Ketamine, a drug currently used in human anesthesia and veterinary medicine, has been shown in clinical studies to be effective in the treatment of several conditions, including the of treatment-resistant bipolar depression, major depressive disorder, neuropathic pain, and chronic pain, including complex regional pain syndrome (CRPS). However the routine use of the drug is hindered by unwanted central nervous system (CNS) effects and a patient response rate of ∼70%. New data suggests that ketamine metabolites can be used with similar results but with an increase in patient response rates and a decrease in undesirable side effects. Potential Commercial Applications: Treatment of pain and depression. Competitive Advantages: • Increased number of patients able to respond to the treatment because it E:\FR\FM\14FEN1.SGM 14FEN1 8266 Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices bypasses the human metabolic machinery needed to convert the drug into its active metabolite(s). • Decreased CNS side effects. Development Stage: In vivo data available (animal). Inventors: Irving W. Wainer, Ph.D. (NIA), Carlos A. Zarate, M.D. (NIMH), Ruin Moaddel, Ph.D. (NIA), Michel Bernier (NIA), Michael E. Goldberg, M.D., Marc C. Toriman, Ph.D. Publications: 1. Moaddel R, et al. A parallel chiralachiral liquid chromatographic method for the determination of the stereoisomers of ketamine and ketamine metabolites in the plasma and urine of patients with complex regional pain syndrome. Talanta. 2010 Oct. 15;82(5):1892–1904. [PMID 20875593] 2. Zarate CA Jr., et al. Relationship of Ketamine’s Plasma Metabolites with Response and Diagnosis, and Side Effects in Major Depression. Manuscript in preparation. 3. Ibrahim L, et al. Course of Improvement in Depressive Symptoms to a Single Intravenous Infusion of Ketamine vs. Add-on Riluzole: Results from a Four-Week, Double-Blind, Placebo-Controlled Study. Neuropsychopharmacology, in press. 4. Zhao X, et al. Population Pharmacokinetic Modeling of Ketamine and Three Major Metabolites in Patients with Treatment-Resistant Bipolar Depression. Br. J. Clin. Phamaco., in press. Intellectual Property: HHS Reference No. E–092–2011/0—U.S. Provisional Application No. 61/547,336 filed 14 Oct. 2011. mstockstill on DSK4VPTVN1PROD with NOTICES Jkt 226001 Dated: February 8, 2012. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. BILLING CODE 4140–01–P National Institutes of Health National Eye Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended, for the review, discussion, and evaluation of individual intramural PO 00000 Frm 00054 Fmt 4703 programs and projects conducted by the National Eye Institute, including consideration of personnel qualifications and performances, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors, National Eye Institute. Date: March 4–5, 2012. Time: 7:00 PM to 5:00 PM. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institutes of Health, Building 31, 31 Center Drive, Bethesda, MD 20892. Contact Person: Sheldon S. Miller, Ph.D., Scientific Director, National Institutes of Health, National Eye Institute, Bethesda, MD 20892, (301) 451–6763. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: www.nei.nih.gov, where an agenda and any additional information will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: February 8, 2012. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2012–3432 Filed 2–13–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES Licensing Contact: Jaime M. Greene, M.S.; 301–435–5559; greenejaime@mail.nih.gov. Collaborative Research Opportunity: The National Institute on Aging, Laboratory of Clinical Investigation, Bioanalytical Chemistry and Drug Discovery Section, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize this technology. For collaboration opportunities, please contact Nicole Guyton, Ph.D. at darackn@mail.nih.gov. 21:57 Feb 13, 2012 Description of Technology: Nucleic acid based vaccines are attractive alternatives to conventional vaccines for a number of reasons. One of the issues with nucleic acid based vaccines is the poor immunogenicity in humans. The subject technology is a method for eliciting improved immune responses with DNA based vaccines. The method involves co-administration of a nucleic acid vaccine with a protein vaccine for the same antigen of interest that is encoded by the DNA vaccine in a primeboost protocol. This methodology increased the immune responses in a SIV macaque model to examine DNA based vaccines of HIV and vaccine protocols. The methodology can potentially be applied to other disease indications to elicit greater immune responses. Potential Commercial Applications: Improve immunogenicity of nucleic acid based vaccines. Competitive Advantages: The methodology increases the immune response of DNA based vaccines. Development Stage: • Early-stage • Pre-clinical • In vitro data available • In vivo data available (animal) Intellectual Property: HHS Reference No. E–239–2009/0—International PCT Application No. PCT/US2011/026325 filed 25 Feb. 2011. Licensing Contact: Kevin W. Chang, Ph.D.; 301–435–5018; changke@mail.nih.gov. [FR Doc. 2012–3412 Filed 2–13–12; 8:45 am] Related Technologies: HHS Reference No. E–174–2006/0— • U.S. Patent Application No. 11/ 688,603 filed 20 Mar. 2007 • Related international applications VerDate Mar<15>2010 Improved DNA-Protein Vaccination Protocols Sfmt 4703 Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which E:\FR\FM\14FEN1.SGM 14FEN1

Agencies

[Federal Register Volume 77, Number 30 (Tuesday, February 14, 2012)]
[Notices]
[Pages 8264-8266]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3412]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.

[[Page 8265]]

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

    Description of Technology: The market continues to have a need for 
therapeutics for treating pain and depression that have efficacy in a 
high percentage of patients but have reduced anaesthetic properties and 
reduced abuse liability. Ketamine, a drug currently used in human 
anesthesia and veterinary medicine, has been shown in clinical studies 
to be effective in the treatment of several conditions, including the 
of treatment-resistant bipolar depression, major depressive disorder, 
neuropathic pain, and chronic pain, including complex regional pain 
syndrome (CRPS). However the routine use of the drug is hindered by 
unwanted central nervous system (CNS) effects and a patient response 
rate of ~70%. New data suggests that ketamine metabolites can be used 
with similar results but with an increase in patient response rates and 
a decrease in undesirable side effects.
    Potential Commercial Applications: Treatment of pain and 
depression.
    Competitive Advantages:
     Increased number of patients able to respond to the 
treatment because it

[[Page 8266]]

bypasses the human metabolic machinery needed to convert the drug into 
its active metabolite(s).
     Decreased CNS side effects.
    Development Stage: In vivo data available (animal).
    Inventors: Irving W. Wainer, Ph.D. (NIA), Carlos A. Zarate, M.D. 
(NIMH), Ruin Moaddel, Ph.D. (NIA), Michel Bernier (NIA), Michael E. 
Goldberg, M.D., Marc C. Toriman, Ph.D.
    Publications:

1. Moaddel R, et al. A parallel chiral-achiral liquid chromatographic 
method for the determination of the stereoisomers of ketamine and 
ketamine metabolites in the plasma and urine of patients with complex 
regional pain syndrome. Talanta. 2010 Oct. 15;82(5):1892-1904. [PMID 
20875593]
2. Zarate CA Jr., et al. Relationship of Ketamine's Plasma Metabolites 
with Response and Diagnosis, and Side Effects in Major Depression. 
Manuscript in preparation.
3. Ibrahim L, et al. Course of Improvement in Depressive Symptoms to a 
Single Intravenous Infusion of Ketamine vs. Add-on Riluzole: Results 
from a Four-Week, Double-Blind, Placebo-Controlled Study. 
Neuropsychopharmacology, in press.
4. Zhao X, et al. Population Pharmacokinetic Modeling of Ketamine and 
Three Major Metabolites in Patients with Treatment-Resistant Bipolar 
Depression. Br. J. Clin. Phamaco., in press.
    Intellectual Property: HHS Reference No. E-092-2011/0--U.S. 
Provisional Application No. 61/547,336 filed 14 Oct. 2011.

Related Technologies: HHS Reference No. E-174-2006/0--
 U.S. Patent Application No. 11/688,603 filed 20 Mar. 2007
 Related international applications

    Licensing Contact: Jaime M. Greene, M.S.; 301-435-5559; 
greenejaime@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute on 
Aging, Laboratory of Clinical Investigation, Bioanalytical Chemistry 
and Drug Discovery Section, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize this technology. For collaboration 
opportunities, please contact Nicole Guyton, Ph.D. at 
darackn@mail.nih.gov.

Improved DNA-Protein Vaccination Protocols

    Description of Technology: Nucleic acid based vaccines are 
attractive alternatives to conventional vaccines for a number of 
reasons. One of the issues with nucleic acid based vaccines is the poor 
immunogenicity in humans. The subject technology is a method for 
eliciting improved immune responses with DNA based vaccines. The method 
involves co-administration of a nucleic acid vaccine with a protein 
vaccine for the same antigen of interest that is encoded by the DNA 
vaccine in a prime-boost protocol. This methodology increased the 
immune responses in a SIV macaque model to examine DNA based vaccines 
of HIV and vaccine protocols. The methodology can potentially be 
applied to other disease indications to elicit greater immune 
responses.
    Potential Commercial Applications: Improve immunogenicity of 
nucleic acid based vaccines.
    Competitive Advantages: The methodology increases the immune 
response of DNA based vaccines.
    Development Stage:

 Early-stage
 Pre-clinical
 In vitro data available
 In vivo data available (animal)

    Intellectual Property: HHS Reference No. E-239-2009/0--
International PCT Application No. PCT/US2011/026325 filed 25 Feb. 2011.
    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
changke@mail.nih.gov.

     Dated: February 8, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-3412 Filed 2-13-12; 8:45 am]
BILLING CODE 4140-01-P

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