Government-Owned Inventions; Availability for Licensing, 71625-71627 [2013-28558]

Download as PDF 71625 Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices enhance implementation of methodologies to improve organizational effectiveness. The main goal of this information is to improve program outcomes and increase the efficiency of resource utilization. The knowledge gained from these collections will be used to strengthen the planning, implementation, and monitoring of NIH research programs, as well as to strengthen strategy management in NIH research programs. The questions asked, and the data to be collected are rooted in established business-based paradigms but administered in a manner that minimizes public information collection burden. These include, but are not limited to, surveys, focus groups, and/ or cognitive interviews. Separate and distinct generic clearances are requested to facilitate the efficiency of submission and review of these projects as required by the OMB Office of Information and Regulatory Affairs OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 4775. specifically adapted for use (and relevance) in a biomedical research environment, in order to discern: 1) Factors that enhance (or inhibit) organizational effectiveness in research programs; 2) utility and acceptance of these kinds of efforts among biomedical researchers and research stakeholders. The results from this formative research project will inform quality improvement activities in several areas, including goal setting, capability and resource evaluation, operational efficiency, and performance monitoring. Utilized data collection methodologies will be ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Pilot Test ....................... Dated: November 21, 2013. Brandie Taylor, Project Clearance Liaison, Chief, Evaluation Section, OPSIDA, NIAID, NIH. [FR Doc. 2013–28636 Filed 11–27–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 900 1 45/60 675 2500 1000 375 150 1 1 1 1 30/60 90/60 2/60 4/60 1250 1500 750 600 Government-Owned Inventions; Availability for Licensing AGENCY: 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 SUMMARY: VerDate Mar<15>2010 17:56 Nov 27, 2013 Jkt 232001 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. Device for Vascular Dilation National Institutes of Health sroberts on DSK5SPTVN1PROD with NOTICES Number of responses per respondent Science professional, researchers, institutional officials, network leadership, program administrators, and research site staff.. ............................................................................... ............................................................................... ............................................................................... ............................................................................... Survey ........................... Interview ........................ Focus group .................. Data interpretation meeting with stakeholders. Description of Technology: The invention is an enhanced vascular dilator that eliminates the vascular injury caused by the size mismatch between vascular introducer sheaths and vascular dilators, as the two are advanced into a blood vessel. The invention provides a ‘‘shoulder’’ to match the diameter of the introducer sheath so that there is a smooth transition, without size mismatch, between the dilator and the introducer sheath. The invention allows the dilator to be withdrawn in segments from the introducer sheath. This is especially valuable to reduce vascular injury when using large-bore introducer sheaths for interventional procedures including transcatheter valves and endografts. Potential Commercial Applications: • Caval access. • Vascular access. Competitive Advantages: Nonperforating. Development Stage: Prototype. PO 00000 Frm 00065 Average burden per response (in hours) Number of respondents Form name Fmt 4703 Sfmt 4703 Total annual burden hour Inventors: Robert Lederman (NHLBI), Ozgur Kocaturk (NHLBI), Adam Greenbaum (Henry Ford Hospital). Intellectual Property: HHS Reference No. E–759–2013/0—US Provisional Patent Application 61/890,961 filed 15 October 2013. Licensing Contact: Michael Shmilovich; 301–435–5019; shmilovm@mail.nih.gov. Collaborative Research Opportunity: The National Heart, Lung, and Blood Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize interventional catheterbased procedures to reduce vascular injury. For collaboration opportunities, please contact Peg Koelble at koelblep@nhlbi.nih.gov. Her2 Monoclonal Antibodies, Antibody Drug Conjugates, and Site Specific Antibody Conjugate Methods Description of Technology: Antibody drug conjugates (ADC) can demonstrate high efficacy as cancer therapeutics, however, much more can be done to improve their efficacy and safety profile. Site-specific antibody drug conjugation is a promising way to do this. The scientists at the NIH have identified a fully human monoclonal antibody, m860, that binds to cell surface-associated Her2 with affinity E:\FR\FM\29NON1.SGM 29NON1 71626 Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices sroberts on DSK5SPTVN1PROD with NOTICES comparable to that of Trastuzumab (Herceptin) but to a different epitope. In addition, the scientist developed a sitespecific glycan engineering method to conjugate the antibody to the small molecule drug auristatin F. The ADC prepared though this site-specific approach shows very good stability, cell surface binding activity and also potent specific cell killing activity against Her2 positive cancer cells, including Trastuzumab resistant breast cancer cells. This ADC has the potential to be developed as a targeted therapeutic for Her2-overexpressing cancers and this site-specific strategy could be readily applied to develop ADCs targeting other cancers that express cell surface markers or other disease targets. Potential Commercial Applications: • Therapeutic for the treatment of Her2 positive cancers. • Method for producing safer and more effective ADCs. Competitive Advantages: • Could be used in combination with Trastuzumab or for patients who have developed resistance to Trastuzumab treatment, since this antibody targets a different epitope. • Site specific conjugation provides better efficacy and less side effects than ADCs produced using traditional strategies. • Can be readily applied to develop ADCs targeting other cancers that express cell surface markers or other disease targets, such as HIV. Development Stage: • Pre-clinical. • In vitro data available. • In vivo data available (animal). Inventors: Dimiter S. Dimitrov (NCI), Zhu Zhongyu (NCI), Pradman K. Qasba (NCI), Boopathy Ramakrishnan (NCI). Intellectual Property: HHS Reference No. E–351–2013/0—US Provisional Application No. 61/833,732 filed 11 June 2013. Licensing Contact: Whitney A. Hastings; 301–451–7337; hastingw@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 monoclonal antibodies, ADCs, and methods. For collaboration opportunities, please contact John D. Hewes, Ph.D. at hewesj@mail.nih.gov. urine samples. Urine samples minimize patient discomfort unlike current early detection methods that are highly invasive, such as a biopsy or bronchoscopy, or utilize expensive computer tomography (CT) scans that expose patients to harmful radiation. Although the sensitivity of low dose CT scans is high, the specificity is low, resulting in high false positive rates. Utilizing metabolic profiling of urine samples obtained from 1,005 people, the scientists have developed and validated this unique metabolite profile that diagnoses early stage lung cancer and predicts patient survival with a high accuracy. Potential Commercial Applications: • Diagnostic test for early stage lung cancer. • Prognostic test for patient survival. • Method to help physicians make informed treatment decisions. Competitive Advantages: Urinary patient samples—no need for needles, invasive surgery, or claustrophobic tests. Development Stage: • Early-stage. • In vivo data available (human). Inventors: Curtis Harris (NCI), Majda Haznadar (NCI), Frank Gonzalez (NCI), Ewy Mathe (NCI), Kristopher Krausz (NCI), Soumen Manna (NCI), and Andrew Patterson (Pennsylvania State University) Intellectual Property: HHS Reference No. E–121–2013/0—US Patent Application No. 61/845,055 filed 11 July 2013 Related Technology: HHS Reference No. E–248–2002/0—US Patent Application No. 10/533,459 filed 02 May 2005; PCT Application No. PCT/ US2013/055746 filed 20 August 2013 Licensing Contact: Jennifer Wong, M.S.; 301–435–4633; wongje@mail.nih.gov. Collaborative Research Opportunity: The National Cancer Institute, Laboratory of Human Carcinogenesis, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Non-invasive Urinary Biomarkers Highly Predictive of Non-small Cell Lung Cancer Status and Survival. For collaboration opportunities, please contact John D. Hewes, Ph.D. at hewesj@mail.nih.gov. Non-invasive Early Stage Lung Cancer Diagnostic and Prognostic Assays Intravenous Water Soluble Formulation of MJC13—A Novel Lead Compound for the Treatment of Castrate-Resistant Prostate Cancer Description of Technology: Normal prostate growth and maintenance is dependent on androgens acting through Description of Technology: The present invention provides a unique non-invasive diagnostic to detect early stage lung cancer and predict patient survival through a simple assay utilizing VerDate Mar<15>2010 17:56 Nov 27, 2013 Jkt 232001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 the androgen receptor (AR). AR expression is maintained and plays an important role throughout prostate cancer progression. A lead molecule, MJC13, has been identified and has higher potency and better selectivity for AR than any other compound tested. It has been shown to effectively block ARdependent gene expression in cellular models of prostate cancer at micromolar concentrations. MJC13, although an attractive drug candidate, has low aqueous solubility. This has hindered the clinical development of MJC13. Scientists at NIH, University of Texas-El-Paso and Texas Southern University have developed a water soluble and stable MJC13 liquid dosage formulation that is suitable for intravenous administration. The solubility of this formulation has increased over 25,000 times compared to MJC13 itself. Additionally, a sensitive LC/MS/MS method to analyze MJC13 has also been developed, which can detect as little as 1 ng/mL of MJC13 in solution or plasma. These studies are of great importance for future pre-clinical and clinical studies of MJC13. Potential Commercial Applications: Develop MJC13 as a clinical drug product for the treatment of castrateresistant prostate cancer (CRPC), in which current treatment options are ineffective. Competitive Advantages: Water soluble formulation of the lead compound, MJC13, that will enable further pharmacokinetic/ pharmacodynamic studies and clinical studies required for commercial development of the drug. Development Stage: • Pre-clinical. • In vitro data available. • In vivo data available (animal). Intellectual Property: HHS Reference No. E–065–2013/0—US Provisional Application No. 61/788,716 filed 15 March 2013. Related Technology: HHS Reference No. E–162–2009/0—US Patent Application No. 13/395,976 filed 14 March 2012. Licensing Contact: Eggerton Campbell, Ph.D.; 301–435–5282; campbellea2@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 this technology with an initial goal of preclinical evaluation and an ultimate goal of clinical testing. For collaboration opportunities, please contact John D. Hewes, Ph.D. at hewesj@mail.nih.gov. E:\FR\FM\29NON1.SGM 29NON1 sroberts on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices Methods of Modulating Chemotherapeutic Cytotoxicity Description of Technology: Investigators at the National Cancer Institute (NCI) have discovered that blockade of the signalling activity of a single cell-surface receptor, CD47, in cancer cells results in enhanced sensitivity of cancer cells to chemotherapy treatment and in healthy tissues reduces damage to normal cells. Many chemotherapeutic agents cause significant cytotoxicity to non-cancer (‘‘normal’’) cells, resulting in undesirable side-effects and often limiting the dose and/or duration of chemotherapy that can be administered to a patient. The present invention relates to a method of using CD47modulating compounds in combination with a chemotherapeutic agent to increase the efficacy of that agent against inhibiting tumor growth. The invention also relates to methods for preventing damage to heart tissue associated with the use of anthracycline chemotherapy. The current invention builds on the NIH’s previous discoveries of antibodies, antisense morpholino oligonucleotides, and peptide compounds that modulate CD47. Potential Commercial Applications: Combination Chemotherapy Competitive Advantages: • Enhance effectiveness of chemotherapeutic agents. • Limit off target effects on normal tissue. • Reduces cytotoxicity of normal cells. • Provides cardioprotection for anthracyclines. Development Stage: • Early-stage. • Pre-clinical. • In vitro data available. • In vivo data available (animal). Inventors: David D. Roberts and David R. Soto Pantoja (NCI). Publication: Soto-Pantoja DR, et al. CD47 deficiency confers cell and tissue radioprotection by activation of autophagy. Autophagy. 2012 Nov;8(11):1628–42. [PMID 22874555] Intellectual Property: HHS Reference No. E–296–2011/0—US Application No. 61/779,587 filed 13 March 2013 Related Technology: HHS Reference No. E–227–2006/5– • US Application No. 12/444,364 filed 03 April 2009. • CA Application No. 2,665,287 filed 05 October 2007. • EP Application No. 07868382.8 filed 27 March 2009. • US Application No. 13/546,941 filed 11 July 2012. • US Application No. 13/546,931 filed 11 July 2012. VerDate Mar<15>2010 17:56 Nov 27, 2013 Jkt 232001 Licensing Contact: Charlene Maddox, Ph.D.; 301–435–4689; sydnorc@mail.nih.gov. Collaborative Research Opportunity: The National Cancer Institute, Laboratory of Pathology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize CD47 targeting therapeutics, cardioprotection, autophagy modulation. For collaboration opportunities, please contact John D. Hewes, Ph.D. at hewesj@mail.nih.gov. Dated: November 21, 2013. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–28558 Filed 11–27–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; 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 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 would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; NIBIB 2014–05 Reducing Health Disparity SBIR Review. Date: March 6, 2014. Time: 10:00 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, Suite 920, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Ruixia Zhou, Ph.D., Scientific Review Officer, 6707 Democracy Boulevard, Suite 957, Bethesda, MD 20892, 301–496–4773, zhour@mail.nih.gov. PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 71627 Dated: November 22, 2013. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–28559 Filed 11–27–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer 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 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 would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; K22 Grant Applications for PAR–12–121. Date: December 3, 2013. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W030, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Sergei Radaev, Ph.D., Scientific Review Officer, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W634, Bethesda, MD 20892, 240– 276–6466, sradaev@mail.nih.gov. This notice is being published less than 15 days prior to the meeting date due to scheduling conflicts. Information is also available on the Institute’s/Center’s home page: http:// deainfo.nci.nih.gov/advisory/sep/sep.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS). E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71625-71627]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28558]


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

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.

Device for Vascular Dilation

    Description of Technology: The invention is an enhanced vascular 
dilator that eliminates the vascular injury caused by the size mismatch 
between vascular introducer sheaths and vascular dilators, as the two 
are advanced into a blood vessel. The invention provides a ``shoulder'' 
to match the diameter of the introducer sheath so that there is a 
smooth transition, without size mismatch, between the dilator and the 
introducer sheath. The invention allows the dilator to be withdrawn in 
segments from the introducer sheath. This is especially valuable to 
reduce vascular injury when using large-bore introducer sheaths for 
interventional procedures including transcatheter valves and 
endografts.
    Potential Commercial Applications:
     Caval access.
     Vascular access.
    Competitive Advantages: Non-perforating.
    Development Stage: Prototype.
    Inventors: Robert Lederman (NHLBI), Ozgur Kocaturk (NHLBI), Adam 
Greenbaum (Henry Ford Hospital).
    Intellectual Property: HHS Reference No. E-759-2013/0--US 
Provisional Patent Application 61/890,961 filed 15 October 2013.
    Licensing Contact: Michael Shmilovich; 301-435-5019; 
shmilovm@mail.nih.gov.
    Collaborative Research Opportunity: The National Heart, Lung, and 
Blood Institute is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize interventional catheter-based procedures to 
reduce vascular injury. For collaboration opportunities, please contact 
Peg Koelble at koelblep@nhlbi.nih.gov.

Her2 Monoclonal Antibodies, Antibody Drug Conjugates, and Site Specific 
Antibody Conjugate Methods

    Description of Technology: Antibody drug conjugates (ADC) can 
demonstrate high efficacy as cancer therapeutics, however, much more 
can be done to improve their efficacy and safety profile. Site-specific 
antibody drug conjugation is a promising way to do this.
    The scientists at the NIH have identified a fully human monoclonal 
antibody, m860, that binds to cell surface-associated Her2 with 
affinity

[[Page 71626]]

comparable to that of Trastuzumab (Herceptin) but to a different 
epitope. In addition, the scientist developed a site-specific glycan 
engineering method to conjugate the antibody to the small molecule drug 
auristatin F. The ADC prepared though this site-specific approach shows 
very good stability, cell surface binding activity and also potent 
specific cell killing activity against Her2 positive cancer cells, 
including Trastuzumab resistant breast cancer cells. This ADC has the 
potential to be developed as a targeted therapeutic for Her2-
overexpressing cancers and this site-specific strategy could be readily 
applied to develop ADCs targeting other cancers that express cell 
surface markers or other disease targets.
    Potential Commercial Applications:
     Therapeutic for the treatment of Her2 positive cancers.
     Method for producing safer and more effective ADCs.
    Competitive Advantages:
     Could be used in combination with Trastuzumab or for 
patients who have developed resistance to Trastuzumab treatment, since 
this antibody targets a different epitope.
     Site specific conjugation provides better efficacy and 
less side effects than ADCs produced using traditional strategies.
     Can be readily applied to develop ADCs targeting other 
cancers that express cell surface markers or other disease targets, 
such as HIV.
    Development Stage:
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Dimiter S. Dimitrov (NCI), Zhu Zhongyu (NCI), Pradman K. 
Qasba (NCI), Boopathy Ramakrishnan (NCI).
    Intellectual Property: HHS Reference No. E-351-2013/0--US 
Provisional Application No. 61/833,732 filed 11 June 2013.
    Licensing Contact: Whitney A. Hastings; 301-451-7337; 
hastingw@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 
monoclonal antibodies, ADCs, and methods. For collaboration 
opportunities, please contact John D. Hewes, Ph.D. at 
hewesj@mail.nih.gov.

Non-invasive Early Stage Lung Cancer Diagnostic and Prognostic Assays

    Description of Technology: The present invention provides a unique 
non-invasive diagnostic to detect early stage lung cancer and predict 
patient survival through a simple assay utilizing urine samples. Urine 
samples minimize patient discomfort unlike current early detection 
methods that are highly invasive, such as a biopsy or bronchoscopy, or 
utilize expensive computer tomography (CT) scans that expose patients 
to harmful radiation. Although the sensitivity of low dose CT scans is 
high, the specificity is low, resulting in high false positive rates. 
Utilizing metabolic profiling of urine samples obtained from 1,005 
people, the scientists have developed and validated this unique 
metabolite profile that diagnoses early stage lung cancer and predicts 
patient survival with a high accuracy.
    Potential Commercial Applications:
     Diagnostic test for early stage lung cancer.
     Prognostic test for patient survival.
     Method to help physicians make informed treatment 
decisions.
    Competitive Advantages: Urinary patient samples--no need for 
needles, invasive surgery, or claustrophobic tests.
    Development Stage:
     Early-stage.
     In vivo data available (human).
    Inventors: Curtis Harris (NCI), Majda Haznadar (NCI), Frank 
Gonzalez (NCI), Ewy Mathe (NCI), Kristopher Krausz (NCI), Soumen Manna 
(NCI), and Andrew Patterson (Pennsylvania State University)
    Intellectual Property: HHS Reference No. E-121-2013/0--US Patent 
Application No. 61/845,055 filed 11 July 2013
    Related Technology: HHS Reference No. E-248-2002/0--US Patent 
Application No. 10/533,459 filed 02 May 2005; PCT Application No. PCT/
US2013/055746 filed 20 August 2013
    Licensing Contact: Jennifer Wong, M.S.; 301-435-4633; 
wongje@mail.nih.gov.
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Human Carcinogenesis, is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate or commercialize Non-invasive Urinary 
Biomarkers Highly Predictive of Non-small Cell Lung Cancer Status and 
Survival. For collaboration opportunities, please contact John D. 
Hewes, Ph.D. at hewesj@mail.nih.gov.

Intravenous Water Soluble Formulation of MJC13--A Novel Lead Compound 
for the Treatment of Castrate-Resistant Prostate Cancer

    Description of Technology: Normal prostate growth and maintenance 
is dependent on androgens acting through the androgen receptor (AR). AR 
expression is maintained and plays an important role throughout 
prostate cancer progression. A lead molecule, MJC13, has been 
identified and has higher potency and better selectivity for AR than 
any other compound tested. It has been shown to effectively block AR-
dependent gene expression in cellular models of prostate cancer at 
micromolar concentrations.
    MJC13, although an attractive drug candidate, has low aqueous 
solubility. This has hindered the clinical development of MJC13. 
Scientists at NIH, University of Texas-El-Paso and Texas Southern 
University have developed a water soluble and stable MJC13 liquid 
dosage formulation that is suitable for intravenous administration. The 
solubility of this formulation has increased over 25,000 times compared 
to MJC13 itself. Additionally, a sensitive LC/MS/MS method to analyze 
MJC13 has also been developed, which can detect as little as 1 ng/mL of 
MJC13 in solution or plasma. These studies are of great importance for 
future pre-clinical and clinical studies of MJC13.
    Potential Commercial Applications: Develop MJC13 as a clinical drug 
product for the treatment of castrate-resistant prostate cancer (CRPC), 
in which current treatment options are ineffective.
    Competitive Advantages: Water soluble formulation of the lead 
compound, MJC13, that will enable further pharmacokinetic/
pharmacodynamic studies and clinical studies required for commercial 
development of the drug.
    Development Stage:
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Intellectual Property: HHS Reference No. E-065-2013/0--US 
Provisional Application No. 61/788,716 filed 15 March 2013.
    Related Technology: HHS Reference No. E-162-2009/0--US Patent 
Application No. 13/395,976 filed 14 March 2012.
    Licensing Contact: Eggerton Campbell, Ph.D.; 301-435-5282; 
campbellea2@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 
this technology with an initial goal of preclinical evaluation and an 
ultimate goal of clinical testing. For collaboration opportunities, 
please contact John D. Hewes, Ph.D. at hewesj@mail.nih.gov.

[[Page 71627]]

Methods of Modulating Chemotherapeutic Cytotoxicity

    Description of Technology: Investigators at the National Cancer 
Institute (NCI) have discovered that blockade of the signalling 
activity of a single cell-surface receptor, CD47, in cancer cells 
results in enhanced sensitivity of cancer cells to chemotherapy 
treatment and in healthy tissues reduces damage to normal cells. Many 
chemotherapeutic agents cause significant cytotoxicity to non-cancer 
(``normal'') cells, resulting in undesirable side-effects and often 
limiting the dose and/or duration of chemotherapy that can be 
administered to a patient. The present invention relates to a method of 
using CD47-modulating compounds in combination with a chemotherapeutic 
agent to increase the efficacy of that agent against inhibiting tumor 
growth. The invention also relates to methods for preventing damage to 
heart tissue associated with the use of anthracycline chemotherapy. The 
current invention builds on the NIH's previous discoveries of 
antibodies, antisense morpholino oligonucleotides, and peptide 
compounds that modulate CD47.
    Potential Commercial Applications: Combination Chemotherapy 
Competitive Advantages:
     Enhance effectiveness of chemotherapeutic agents.
     Limit off target effects on normal tissue.
     Reduces cytotoxicity of normal cells.
     Provides cardioprotection for anthracyclines.
    Development Stage:
     Early-stage.
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: David D. Roberts and David R. Soto Pantoja (NCI).
    Publication: Soto-Pantoja DR, et al. CD47 deficiency confers cell 
and tissue radioprotection by activation of autophagy. Autophagy. 2012 
Nov;8(11):1628-42. [PMID 22874555]
    Intellectual Property: HHS Reference No. E-296-2011/0--US 
Application No. 61/779,587 filed 13 March 2013
    Related Technology: HHS Reference No. E-227-2006/5-
     US Application No. 12/444,364 filed 03 April 2009.
     CA Application No. 2,665,287 filed 05 October 2007.
     EP Application No. 07868382.8 filed 27 March 2009.
     US Application No. 13/546,941 filed 11 July 2012.
     US Application No. 13/546,931 filed 11 July 2012.
    Licensing Contact: Charlene Maddox, Ph.D.; 301-435-4689; 
sydnorc@mail.nih.gov.
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Pathology, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize CD47 targeting therapeutics, 
cardioprotection, autophagy modulation. For collaboration 
opportunities, please contact John D. Hewes, Ph.D. at 
hewesj@mail.nih.gov.

    Dated: November 21, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-28558 Filed 11-27-13; 8:45 am]
BILLING CODE 4140-01-P