Government-Owned Inventions; Availability for Licensing, 78370-78372 [2013-30745]

Download as PDF 78370 Federal Register / Vol. 78, No. 248 / Thursday, December 26, 2013 / Notices ALKCAR58, can be used in adoptive cell therapy treatment for neuroblastoma and other solid tumors which overexpress ALK or variants thereof. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: Potential Commercial Applications: National Institutes of Health, HHS. ACTION: Notice. 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. 209 and 37 CFR Part 404 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. FOR FURTHER INFORMATION CONTACT: 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: emcdonald on DSK67QTVN1PROD with NOTICES Chimeric Antigen Receptors to ALK for Treating Neuroblastoma and Other Solid Tumors Description of Technology: Chimeric antigen receptors (CARs) are hybrid proteins consisting of an antibody binding fragment fused to protein signaling domains that cause T-cells which express the CAR to become cytotoxic. Once activated, these cytotoxic T-cells can selectively eliminate the cells which they recognize via the antibody binding fragment of the CAR. By engineering a T-cell to express a CAR that is specific for a certain cell surface protein, it is possible to selectively target those cells for destruction. This is a promising new therapeutic approach known as adoptive cell therapy. Anaplastic lymphoma kinase (ALK, CD246) is a tumor-associated antigen that is expressed on the cell surface of pediatric neuroblastomas and some nonsmall cell lung carcinomas (NSCLC). This technology concerns the development of four (4) CARs, each comprising a different antibody binding fragment to ALK. The CARs, known individually as ALKCAR15, ALKCAR48, ALKCAR53 and VerDate Mar<15>2010 18:06 Dec 24, 2013 Jkt 232001 • Treatment of cancers associated with expression of ALK or variants thereof. • Specific cancers include neuroblastoma, NSCLC and other solid tumors. Competitive Advantages: • High affinity of the ALKCAR15, ALKCAR48, ALKCAR53 and ALKCAR58 increases the likelihood of successful targeting. • Targeted therapy decreases nonspecific killing of healthy, essential cells, resulting in fewer non-specific side-effects and healthier patients. Development Stage: • Early-stage • In vitro data available • In vivo data available (animal) Inventors: Rimas J. Orentas and Crystal L. Mackall (NCI) Publication: Orentas RJ, et al. ALK (anaplastic lymphoma kinase, CD246)specific CARs: new immunotherapeutic agents for the treatment of pediatric solid tumors. J Immunother Cancer. 2013 Nov 7;1 (Suppl 1):P27. [doi:10.1186/2051–1426–1–S1–P27] (Poster presentation) Intellectual Property: HHS Reference No. E–007–2014/0—U.S. Provisional Patent Application No. 61/865,845 filed 06 November 2013 Related Technologies: • HHS Reference No. E–104–2013/ 0—US Provisional Patent Application No. 61/805,001 filed 25 March 2013 (‘‘Anti-CD276 Polypeptides, Proteins, and Chimeric Antigen Receptors,’’ Orentas RJ, et al.) • HHS Reference No. E–291–2012/ 0—International Patent Application No. PCT/US2013/060332 filed 18 September 2013 (‘‘M971 Chimeric Antigen Receptors,’’ Orentas RJ, et al.) Licensing Contact: David A. Lambertson, Ph.D.; 301–435–4632; lambertsond@mail.nih.gov. Collaborative Research Opportunity: The Pediatric Oncology Branch, CCR, NCI, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize CAR (chimeric antigen receptor) T cells specific for the ALK tumor-associated antigen. For collaboration opportunities, please contact John D. Hewes, Ph.D. at hewesj@mail.nih.gov. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Acid-Resistant, Attenuated Microbial Vector for Improved Oral Delivery of Multiple Targeted Antigens Description of Technology: Ty21a, the licensed oral live, attenuated bacterial vaccine for Salmonella typhi (the causative agent of typhoid fever), has been engineered to stably express a variety of target LPS (lipopolysaccharides) and protein antigens to protect against shigellosis, anthrax, and plague. Ty21a induces mucosal, humoral, and cellular immunity and can be utilized as a multivalent vaccine vector that is inexpensive to produce. Salmonella species encode inducible acid tolerance, but this genus does not survive well below pH 4. Shigella and enterohemorrhagic E. coli isolates have more effective acid resistance systems than Salmonella and can survive an extreme acid challenge of pH 1–2 (the acidity of the human stomach when full). This application claims an engineered Ty21a vector that can survive a very low pH for two to three hours (i.e.. normal transit time through a full stomach), allowing for a final delivery format for Ty21a as a rapidly dissolvable wafer, instead of the large bullet-size entericcoated capsule, which small children cannot swallow. This formulation enhances the ability of the immunogenic composition and/or vaccine to stimulate immune responses sublingually and throughout the intestinal tract. Potential Commercial Applications: • Shigella vaccines • Biodefense vaccines • Diagnostics Competitive Advantages: • Ease of manufacture • Inexpensive to manufacture • Ease of administration • Known live attenuated bacterial vector Development Stage: • Pre-clinical • In vitro data available • In vivo data available (animal) Inventors: Madushini N. Dharmasena and Dennis J. Kopecko (FDA/CBER) Intellectual Property: HHS Reference No. E–535–2013/0—US Provisional Application No. 61/862,815 filed 06 August 2013 Licensing Contact: Peter Soukas; 301– 435–4646; ps193c@nih.gov Collaborative Research Opportunity: The Food and Drug Administration, Center for Biologics Evaluation and Research, is seeking statements of capability or interest from parties E:\FR\FM\26DEN1.SGM 26DEN1 Federal Register / Vol. 78, No. 248 / Thursday, December 26, 2013 / Notices interested in collaborative research to further develop, evaluate or commercialize acid-resistant Shigellosis vaccines. For collaboration opportunities, please contact Alice Welch, Ph.D. at 301–796–8449 or alice.welch@fda.hhs.gov. Assay to Screen Anti-metastatic Drugs Description of Technology: Scientists at the NIH have developed a research tool, a murine cell line model (JygMC(A)) with a reporter construct, of spontaneous metastatic mammary carcinoma that resembles the human breast cancer metastatic process in a triple negative mammary tumor. The assay is useful for screening compounds that specifically inhibit pathways involved in mammary carcinoma and can improve clinical management of triple negative breast cancer which are greatly refractory to conventional chemo and radiotherapy. The key feature of the cell line is that when introduced orthotopically into the mammary gland of immunocompromised mice it produces murine mammary tumors that rapidly metastasize to distant sites, such as lungs, lymph nodes, liver and kidneys. This allows for precise tracking of tumor growth and metastasis. Potential Commercial Applications: • Laboratory tool to investigate molecular mechanisms and/or signaling pathways involved in tumorigenesis, angiogenesis and metastasis of breast cancer and its response to therapy (in vivo and in vitro). • Research tool for high through-put screening of libraries for compounds that specifically inhibit mechanisms and/or signaling pathways involved in metastatic triple negative breast cancer. • Research tool to optimize therapeutic regimens. Competitive Advantages: Dual report construct: enhanced green fluorescent protein (eGFP) or a fusion of firefly luciferase and eGFP (ffLuc2-eFGP) and mouse Cripto-1 promoter sequence cloned into a vector for reporter assays and/or visualization of molecular mechanisms involved in tumorigenesis of metastatic breast cancer cells. emcdonald on DSK67QTVN1PROD with NOTICES Development Stage: • Pre-clinical • In vitro data available • In vivo data available (animal) Inventors: Nadia P. Castro, David S. Salomon, Frank F. Cuttitta (all of NCI) Publications: 1. Castro, Nadia P. ‘‘Role of the Notch signaling in the metastasis of a murine breast cancer model.’’ Abstract presented at the Mammary Gland VerDate Mar<15>2010 18:06 Dec 24, 2013 Jkt 232001 Biology Gordon Research Conference, Lucca (Barga) Italy, June 10–15, 2012. 2. Castro, Nadia P. ‘‘Notch pathway in an experimental model of breast cancer metastasis.’’ Abstract presented at the Sixth AACR Special Conference on Advances in Breast Cancer Research, San Francisco, California, October 12– 15, 2011. Intellectual Property: HHS Reference No. E–088–2013/0—Research Tool. Patent protection is not being pursued for this technology. Licensing Contact: Surekha Vathyam, Ph.D.; 301–435–4076; vathyams@ 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 mechanism of tumor growth and lung metastasis. For collaboration opportunities, please contact John D. Hewes, Ph.D. at hewesj@ mail.nih.gov. Mouse Model for the Preclinical Study of Metastatic Disease Description of Technology: The successful development of new cancer therapeutics requires reliable preclinical data that are obtained from mouse models for cancer. Human tumor xenografts, which require transplantation of human tumor cells into an immune compromised mouse, represent the current standard mouse model for cancer. Since the immune system plays an important role in tumor growth, progression and metastasis, the current standard mouse model is not ideal for accurate prediction of therapeutic effectiveness in patients. This may contribute to increased failure in later phases of clinical trials, as appropriate tumor-host interactions are not preserved. This technology establishes a system for producing mouse cancer models where the model is not immune compromised, providing an environment which is more akin to the disease state of cancer patients. To establish the model, a tumor is (a) developed in tissue that has been propagated by serial transplantation (rather than cell culture), (b) labeled (using lentiviral vectors) with bioimaging markers (e.g., green fluorescent protein (GFP) and luciferase), and (c) transplanted into immunocompetent mice. Once established, the model can be used to monitor tumor growth, progression and metastasis through standard imaging techniques. The effectiveness of a given therapeutic approach can also be monitored using the same techniques. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 78371 Potential Commercial Applications: • Improved mouse model for preclinical testing of drugs to treat metastatic disease • Can be applied to any cancer where tumor cell lines can be developed without cell culture propagation • Can be used to build preclinical models that require consistent disease tracking and normal immune context (e.g. bone marrow transplantation, stem cell therapy, tissue regeneration) Competitive Advantages: • Labeling markers are tolerized, allowing consistent expression in this mouse • Increase in accurate prediction of drug effectiveness during preclinical stages; allows better prediction of success at later clinical stages • Mice are not immunocompromised, and thereby more accurately representing in vivo disease states • Labeling of tumors for transplantation allows tumors to be traced during growth, progression and metastasis in normal immune context • Labeling also allows more efficient study of the effectiveness of treatments Development Stage: • Early-stage • In vitro data available • In vivo data available (animal) Inventors: Chi-Ping Day and Glenn Merlino (NCI) Publications: 1. Day CP, et al. Preclinical therapeutic response of residual metastatic disease is distinct from its primary tumor of origin. Int J Cancer. 2012 Jan 1;130(1):190–9. [PMID 21312195]. 2. Day CP, et al. Immunological naturalization of immunocompetent host mice to luciferase-GFP for consistent tracking of transplanted tumors. Poster #1556, Annual Meeting 2013, American Association of Cancer Research, Washington, DC, April 6–10, 2013. Intellectual Property: HHS Reference No. E–296–2012/0—Biological Material/ Research Tool. Patent protection is not being pursued for this technology. 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 preclinical models allowing consistent disease tracking in normal immune context. For collaboration opportunities, please E:\FR\FM\26DEN1.SGM 26DEN1 78372 Federal Register / Vol. 78, No. 248 / Thursday, December 26, 2013 / Notices contact John D. Hewes, Ph.D. at hewesj@ mail.nih.gov. Software for Evaluating Drug Induced Hepatotoxicity Description of Technology: This invention pertains to a software tool for assisting differential medical diagnosis of drug-induced liver injury (hepatotoxicity) using clinical trial data. The software is capable of identifying a small subset of patients at risk for hepatotoxicity out of a pool of thousands of clinical trial participants. This software tool is the only one of its kind developed using SAS/IntrNet®. Potential Commercial Applications: • Hepatotoxicity detection • Drug interactions Competitive Advantages: • Personalized predictions • SAS/IntrNet® compatible Development Stage: Prototype Inventor: Ted J. Guo (FDA) Publications: 1. Guo T, et al. A Tool to Help You Decide [detect potentially serious liver injury]. Silver Spring, Maryland: Presentation at the Annual Conference of the American Association for the Study of Liver Diseases, 2008. 2. Guo T, et al. How a SAS/IntrNet tool was created at the FDA for the detection of potential drug-induced liver injury using data with CDISC standard. San Diego, California: Proceedings of the Western Users of SAS Software Annual Conference, 2009. 3. Watkins PB, et al. Evaluation of drug-induced serious hepatotoxicity (eDISH): application of this data organization approach to phase III clinical trials of rivaroxaban after total hip or knee replacement surgery. Drug Saf. 2011 Mar 1;34(3):243–52. [PMID 21332248] Intellectual Property: HHS Reference No. E–103–2012/0—Software Tool. Patent protection is not being pursued for this technology. Licensing Contact: Michael Shmilovich; 301–435–5019; shmilovm@ mail.nih.gov. emcdonald on DSK67QTVN1PROD with NOTICES Hexanucleotide Repeat in the C9orf72 Gene for the Diagnosis and Treatment of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Description of Technology: This invention relates to the discovery of a pathogenic GGCCCC hexanucleotide repeat expansion in the first intron of the C9orf72 gene on chromosome 9p21 in patients exhibiting amyotrophic lateral sclerosis (ALS) and/or frontotemporal dementia (FTD). The VerDate Mar<15>2010 18:06 Dec 24, 2013 Jkt 232001 inventors have previously identified a strong association signal in this genomic region and used this information to identify the underlying pathogenic mutation. The pathogenic repeat expansion accounts for up to 50% of familial ALS and familial FTD cases and up to 10% of sporadic ALS and sporadic FTD cases in European ancestry populations. The inventors represent that this finding will be the basis of diagnostic screening for ALS and/or FTD patients, as well as an important target in the development of therapeutics for ALS and/or FTD. Potential Commercial Applications: Diagnosis and treatment of ALS and/or FTD. Competitive Advantages: Improved diagnosis and treatment of ALS and/or FTD. Development Stage: In vitro data available Inventors: Stuart Pickering-Brown (The University of Manchester), Bryan Traynor (NIA), Andrew Singleton (NIA), Huw Morris (Cardiff University), Peter Heutink (Vu University Medical Center Amsterdam), John Hardy (University College London), Pentti Tienari (University of Helsinki) Intellectual Property: HHS Reference No. E–275–2011/0— • US Provisional Application No. 61/ 529,531 filed 31 August 2011 • PCT Application No. PCT/GB2012/ 052140 filed 31 August 2012 Licensing Contact: Jaime M. Greene; 301–435–5559; greenejaime@ mail.nih.gov Dated: December 19, 2013. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–30745 Filed 12–24–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 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, PO 00000 Frm 00048 Fmt 4703 Sfmt 9990 and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict; Biological Chemistry and Macromolecular Biophysics. Date: January 6, 2014. Time: 1:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: John L. Bowers, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4170, MSC 7806, Bethesda, MD 20892, (301) 435– 1725, bowersj@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Date: January 16, 2014. Time: 2:30 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Lynn E. Luethke, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5166, MSC 7844, Bethesda, MD 20892, (301) 806– 3323, luethkel@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Program Project: Research Resources Reverse Site Visit. Date: January 21–23, 2014. Time: 7:00 p.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: Crowne Plaza Washington, DC— Rockville Hotel, 3 Research Ct., Rockville, MD 20850. Contact Person: Lee Rosen, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5116, MSC 7854, Bethesda, MD 20892, (301) 435– 1171, rosenl@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: December 19, 2013. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–30747 Filed 12–24–13; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\26DEN1.SGM 26DEN1

Agencies

[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Notices]
[Pages 78370-78372]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30745]



[[Page 78370]]

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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, 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. 209 and 37 CFR Part 404 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.

FOR FURTHER INFORMATION CONTACT: 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.

Chimeric Antigen Receptors to ALK for Treating Neuroblastoma and Other 
Solid Tumors

    Description of Technology: Chimeric antigen receptors (CARs) are 
hybrid proteins consisting of an antibody binding fragment fused to 
protein signaling domains that cause T-cells which express the CAR to 
become cytotoxic. Once activated, these cytotoxic T-cells can 
selectively eliminate the cells which they recognize via the antibody 
binding fragment of the CAR. By engineering a T-cell to express a CAR 
that is specific for a certain cell surface protein, it is possible to 
selectively target those cells for destruction. This is a promising new 
therapeutic approach known as adoptive cell therapy.
    Anaplastic lymphoma kinase (ALK, CD246) is a tumor-associated 
antigen that is expressed on the cell surface of pediatric 
neuroblastomas and some non-small cell lung carcinomas (NSCLC). This 
technology concerns the development of four (4) CARs, each comprising a 
different antibody binding fragment to ALK. The CARs, known 
individually as ALKCAR15, ALKCAR48, ALKCAR53 and ALKCAR58, can be used 
in adoptive cell therapy treatment for neuroblastoma and other solid 
tumors which overexpress ALK or variants thereof.

Potential Commercial Applications:

     Treatment of cancers associated with expression of ALK or 
variants thereof.
     Specific cancers include neuroblastoma, NSCLC and other 
solid tumors.

Competitive Advantages:

     High affinity of the ALKCAR15, ALKCAR48, ALKCAR53 and 
ALKCAR58 increases the likelihood of successful targeting.
     Targeted therapy decreases non-specific killing of 
healthy, essential cells, resulting in fewer non-specific side-effects 
and healthier patients.

Development Stage:

     Early-stage
     In vitro data available
     In vivo data available (animal)
    Inventors: Rimas J. Orentas and Crystal L. Mackall (NCI)
    Publication: Orentas RJ, et al. ALK (anaplastic lymphoma kinase, 
CD246)-specific CARs: new immunotherapeutic agents for the treatment of 
pediatric solid tumors. J Immunother Cancer. 2013 Nov 7;1 (Suppl 
1):P27. [doi:10.1186/2051-1426-1-S1-P27] (Poster presentation)
    Intellectual Property: HHS Reference No. E-007-2014/0--U.S. 
Provisional Patent Application No. 61/865,845 filed 06 November 2013

Related Technologies:

     HHS Reference No. E-104-2013/0--US Provisional Patent 
Application No. 61/805,001 filed 25 March 2013 (``Anti-CD276 
Polypeptides, Proteins, and Chimeric Antigen Receptors,'' Orentas RJ, 
et al.)
     HHS Reference No. E-291-2012/0--International Patent 
Application No. PCT/US2013/060332 filed 18 September 2013 (``M971 
Chimeric Antigen Receptors,'' Orentas RJ, et al.)
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
lambertsond@mail.nih.gov.
    Collaborative Research Opportunity: The Pediatric Oncology Branch, 
CCR, NCI, is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate or 
commercialize CAR (chimeric antigen receptor) T cells specific for the 
ALK tumor-associated antigen. For collaboration opportunities, please 
contact John D. Hewes, Ph.D. at hewesj@mail.nih.gov.

Acid-Resistant, Attenuated Microbial Vector for Improved Oral Delivery 
of Multiple Targeted Antigens

    Description of Technology: Ty21a, the licensed oral live, 
attenuated bacterial vaccine for Salmonella typhi (the causative agent 
of typhoid fever), has been engineered to stably express a variety of 
target LPS (lipopolysaccharides) and protein antigens to protect 
against shigellosis, anthrax, and plague. Ty21a induces mucosal, 
humoral, and cellular immunity and can be utilized as a multivalent 
vaccine vector that is inexpensive to produce. Salmonella species 
encode inducible acid tolerance, but this genus does not survive well 
below pH 4. Shigella and enterohemorrhagic E. coli isolates have more 
effective acid resistance systems than Salmonella and can survive an 
extreme acid challenge of pH 1-2 (the acidity of the human stomach when 
full).
    This application claims an engineered Ty21a vector that can survive 
a very low pH for two to three hours (i.e.. normal transit time through 
a full stomach), allowing for a final delivery format for Ty21a as a 
rapidly dissolvable wafer, instead of the large bullet-size enteric-
coated capsule, which small children cannot swallow. This formulation 
enhances the ability of the immunogenic composition and/or vaccine to 
stimulate immune responses sublingually and throughout the intestinal 
tract.

Potential Commercial Applications:

     Shigella vaccines
     Biodefense vaccines
     Diagnostics

Competitive Advantages:

     Ease of manufacture
     Inexpensive to manufacture
     Ease of administration
     Known live attenuated bacterial vector

Development Stage:

     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Madushini N. Dharmasena and Dennis J. Kopecko (FDA/CBER)
    Intellectual Property: HHS Reference No. E-535-2013/0--US 
Provisional Application No. 61/862,815 filed 06 August 2013
    Licensing Contact: Peter Soukas; 301-435-4646; ps193c@nih.gov
    Collaborative Research Opportunity: The Food and Drug 
Administration, Center for Biologics Evaluation and Research, is 
seeking statements of capability or interest from parties

[[Page 78371]]

interested in collaborative research to further develop, evaluate or 
commercialize acid-resistant Shigellosis vaccines. For collaboration 
opportunities, please contact Alice Welch, Ph.D. at 301-796-8449 or 
alice.welch@fda.hhs.gov.

Assay to Screen Anti-metastatic Drugs

    Description of Technology: Scientists at the NIH have developed a 
research tool, a murine cell line model (JygMC(A)) with a reporter 
construct, of spontaneous metastatic mammary carcinoma that resembles 
the human breast cancer metastatic process in a triple negative mammary 
tumor. The assay is useful for screening compounds that specifically 
inhibit pathways involved in mammary carcinoma and can improve clinical 
management of triple negative breast cancer which are greatly 
refractory to conventional chemo and radiotherapy. The key feature of 
the cell line is that when introduced orthotopically into the mammary 
gland of immunocompromised mice it produces murine mammary tumors that 
rapidly metastasize to distant sites, such as lungs, lymph nodes, liver 
and kidneys. This allows for precise tracking of tumor growth and 
metastasis.

Potential Commercial Applications:

     Laboratory tool to investigate molecular mechanisms and/or 
signaling pathways involved in tumorigenesis, angiogenesis and 
metastasis of breast cancer and its response to therapy (in vivo and in 
vitro).
     Research tool for high through-put screening of libraries 
for compounds that specifically inhibit mechanisms and/or signaling 
pathways involved in metastatic triple negative breast cancer.
     Research tool to optimize therapeutic regimens.
    Competitive Advantages: Dual report construct: enhanced green 
fluorescent protein (eGFP) or a fusion of firefly luciferase and eGFP 
(ffLuc2-eFGP) and mouse Cripto-1 promoter sequence cloned into a vector 
for reporter assays and/or visualization of molecular mechanisms 
involved in tumorigenesis of metastatic breast cancer cells.

Development Stage:

     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Nadia P. Castro, David S. Salomon, Frank F. Cuttitta 
(all of NCI)

Publications:

    1. Castro, Nadia P. ``Role of the Notch signaling in the metastasis 
of a murine breast cancer model.'' Abstract presented at the Mammary 
Gland Biology Gordon Research Conference, Lucca (Barga) Italy, June 10-
15, 2012.
    2. Castro, Nadia P. ``Notch pathway in an experimental model of 
breast cancer metastasis.'' Abstract presented at the Sixth AACR 
Special Conference on Advances in Breast Cancer Research, San 
Francisco, California, October 12-15, 2011.
    Intellectual Property: HHS Reference No. E-088-2013/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Surekha Vathyam, Ph.D.; 301-435-4076; 
vathyams@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 
mechanism of tumor growth and lung metastasis. For collaboration 
opportunities, please contact John D. Hewes, Ph.D. at 
hewesj@mail.nih.gov.

Mouse Model for the Preclinical Study of Metastatic Disease

    Description of Technology: The successful development of new cancer 
therapeutics requires reliable preclinical data that are obtained from 
mouse models for cancer. Human tumor xenografts, which require 
transplantation of human tumor cells into an immune compromised mouse, 
represent the current standard mouse model for cancer. Since the immune 
system plays an important role in tumor growth, progression and 
metastasis, the current standard mouse model is not ideal for accurate 
prediction of therapeutic effectiveness in patients. This may 
contribute to increased failure in later phases of clinical trials, as 
appropriate tumor-host interactions are not preserved.
    This technology establishes a system for producing mouse cancer 
models where the model is not immune compromised, providing an 
environment which is more akin to the disease state of cancer patients. 
To establish the model, a tumor is (a) developed in tissue that has 
been propagated by serial transplantation (rather than cell culture), 
(b) labeled (using lentiviral vectors) with bioimaging markers (e.g., 
green fluorescent protein (GFP) and luciferase), and (c) transplanted 
into immunocompetent mice. Once established, the model can be used to 
monitor tumor growth, progression and metastasis through standard 
imaging techniques. The effectiveness of a given therapeutic approach 
can also be monitored using the same techniques.

Potential Commercial Applications:

     Improved mouse model for preclinical testing of drugs to 
treat metastatic disease
     Can be applied to any cancer where tumor cell lines can be 
developed without cell culture propagation
     Can be used to build preclinical models that require 
consistent disease tracking and normal immune context (e.g. bone marrow 
transplantation, stem cell therapy, tissue regeneration)

Competitive Advantages:

     Labeling markers are tolerized, allowing consistent 
expression in this mouse
     Increase in accurate prediction of drug effectiveness 
during preclinical stages; allows better prediction of success at later 
clinical stages
     Mice are not immunocompromised, and thereby more 
accurately representing in vivo disease states
     Labeling of tumors for transplantation allows tumors to be 
traced during growth, progression and metastasis in normal immune 
context
     Labeling also allows more efficient study of the 
effectiveness of treatments

Development Stage:

     Early-stage
     In vitro data available
     In vivo data available (animal)
    Inventors: Chi-Ping Day and Glenn Merlino (NCI)

Publications:

    1. Day CP, et al. Preclinical therapeutic response of residual 
metastatic disease is distinct from its primary tumor of origin. Int J 
Cancer. 2012 Jan 1;130(1):190-9. [PMID 21312195].
    2. Day CP, et al. Immunological naturalization of immunocompetent 
host mice to luciferase-GFP for consistent tracking of transplanted 
tumors. Poster 1556, Annual Meeting 2013, American Association 
of Cancer Research, Washington, DC, April 6-10, 2013.
    Intellectual Property: HHS Reference No. E-296-2012/0--Biological 
Material/Research Tool. Patent protection is not being pursued for this 
technology.
    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 
preclinical models allowing consistent disease tracking in normal 
immune context. For collaboration opportunities, please

[[Page 78372]]

contact John D. Hewes, Ph.D. at hewesj@mail.nih.gov.

Software for Evaluating Drug Induced Hepatotoxicity

    Description of Technology: This invention pertains to a software 
tool for assisting differential medical diagnosis of drug-induced liver 
injury (hepatotoxicity) using clinical trial data. The software is 
capable of identifying a small subset of patients at risk for 
hepatotoxicity out of a pool of thousands of clinical trial 
participants. This software tool is the only one of its kind developed 
using SAS/IntrNet[supreg].

Potential Commercial Applications:

     Hepatotoxicity detection
     Drug interactions

Competitive Advantages:

     Personalized predictions
     SAS/IntrNet[supreg] compatible
    Development Stage: Prototype
    Inventor: Ted J. Guo (FDA)

Publications:

    1. Guo T, et al. A Tool to Help You Decide [detect potentially 
serious liver injury]. Silver Spring, Maryland: Presentation at the 
Annual Conference of the American Association for the Study of Liver 
Diseases, 2008.
    2. Guo T, et al. How a SAS/IntrNet tool was created at the FDA for 
the detection of potential drug-induced liver injury using data with 
CDISC standard. San Diego, California: Proceedings of the Western Users 
of SAS Software Annual Conference, 2009.
    3. Watkins PB, et al. Evaluation of drug-induced serious 
hepatotoxicity (eDISH): application of this data organization approach 
to phase III clinical trials of rivaroxaban after total hip or knee 
replacement surgery. Drug Saf. 2011 Mar 1;34(3):243-52. [PMID 21332248]
    Intellectual Property: HHS Reference No. E-103-2012/0--Software 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Michael Shmilovich; 301-435-5019; 
shmilovm@mail.nih.gov.

Hexanucleotide Repeat in the C9orf72 Gene for the Diagnosis and 
Treatment of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia

    Description of Technology: This invention relates to the discovery 
of a pathogenic GGCCCC hexanucleotide repeat expansion in the first 
intron of the C9orf72 gene on chromosome 9p21 in patients exhibiting 
amyotrophic lateral sclerosis (ALS) and/or frontotemporal dementia 
(FTD). The inventors have previously identified a strong association 
signal in this genomic region and used this information to identify the 
underlying pathogenic mutation. The pathogenic repeat expansion 
accounts for up to 50% of familial ALS and familial FTD cases and up to 
10% of sporadic ALS and sporadic FTD cases in European ancestry 
populations. The inventors represent that this finding will be the 
basis of diagnostic screening for ALS and/or FTD patients, as well as 
an important target in the development of therapeutics for ALS and/or 
FTD.
    Potential Commercial Applications: Diagnosis and treatment of ALS 
and/or FTD.
    Competitive Advantages: Improved diagnosis and treatment of ALS 
and/or FTD.
    Development Stage: In vitro data available
    Inventors: Stuart Pickering-Brown (The University of Manchester), 
Bryan Traynor (NIA), Andrew Singleton (NIA), Huw Morris (Cardiff 
University), Peter Heutink (Vu University Medical Center Amsterdam), 
John Hardy (University College London), Pentti Tienari (University of 
Helsinki)
    Intellectual Property: HHS Reference No. E-275-2011/0--
     US Provisional Application No. 61/529,531 filed 31 August 
2011
     PCT Application No. PCT/GB2012/052140 filed 31 August 2012
    Licensing Contact: Jaime M. Greene; 301-435-5559; 
greenejaime@mail.nih.gov

     Dated: December 19, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-30745 Filed 12-24-13; 8:45 am]
BILLING CODE 4140-01-P