[Federal Register Volume 79, Number 199 (Wednesday, October 15, 2014)]
[Notices]
[Pages 61877-61879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24403]


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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.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 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.

[[Page 61878]]


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.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

The Use of Chimeric Antigen Receptor To Control HIV Infection

    Description of Technology: Chimeric Antigen Receptors (CARs) are 
engineered proteins expressed by transduction on autologous CD8 T 
cells; after adoptive transfer, they promote targeted killing of 
specific cell types. CARs are showing great promise for treating 
cancer. The present invention (CD4-CRD CAR) is a novel bifunctional 
targeting motif for an anti-HIV CAR, consisting of a region of human 
CD4 linked to a carbohydrate recognition domain (CRD) from one of 
several human C-type lectins known to interact with high-mannose 
glycans on HIV gp120. Compared to a ``standard'' CD4 CAR, the CD4-CRD 
CAR displays two major enhancements: (1) Increased potency for 
suppression of HIV-1 infection by selective killing of productively 
infected cells, and (2) complete absence of CD4-mediated entry receptor 
activity that would otherwise render the transduced CD8 T cells 
susceptible to HIV infection. Compared to antibody-based anti-HIV CARs, 
the CD4-CRD CAR of the present invention is predicted to have two major 
advantages: (1) Lower escape potential, due to the universality of HIV 
CD4-dependence and high-mannose glycan display on gp120, and (2) 
reduced immunogenicity, since the all-human CD4-CRD CAR sequences are 
devoid of variable regions that would likely elicit anti-idiotypic 
antibody responses against scFv-based targeting motifs.
    Potential Commercial Applications:
     Therapy for HIV infection
     Research on antiretroviral infection
    Competitive Advantages: Enhanced potency for HIV inhibition and 
does not render transduced CD8T cells susceptible to HIV infection.
    Development Stage:
     In vitro data available
     In vivo data available (animal)
    Inventors: Mustafa H. Ghanem, Bama Dey, Edward Berger (all of 
NIAID)
    Publications:
    1. Scholler J, et al. Decade-long safety and function of 
retroviral-modified chimeric antigen receptor T cells. Sci Transl Med. 
2012 May 2;4(132):132ra53. [PMID 22553251]
    2. Du T, et al. Bifunctional CD4-DC-SIGN fusion proteins 
demonstrate enhanced avidity to gp120 and inhibit HIV-1 infection and 
dissemination. Antimicrob Agents Chemother. 2012 Sep;56(9):4640-9. 
[PMID 22687513]
    3. Lamers CH, et al. Immune responses to transgene and retroviral 
vector in patients treated with ex vivo-engineered T cells. Blood. 2011 
Jan 6;117(1):72-82. [PMID 20889925]
    Intellectual Property: HHS Reference No. E-212-2014/0--US 
Provisional Application No. 62/040,398 filed 21 August 2014
    Licensing Contact: John Stansberry, Ph.D.; 301-435-5236; 
[email protected]
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases 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 Chris Kornak at [email protected].

Photo-Controlled Removal of Targets In Vitro and In Vivo

    Description of Technology: The invention relates to a novel 
technology for separation, isolation and removal of target molecules or 
cells from a complex mixture. The technology can be used for both in 
vitro and in vivo applications. It comprises a conjugate of a 
biomolecule with specific binding activity (e.g. antibody, hapten, 
protein, nucleic acid) and the fluorescence dye IR700. When the 
conjugate is allowed to contact with a sample, it binds to the target 
molecule in the sample to form a biological complex. Upon exposure to 
near infrared light (NIR) of approximately 700 nm the biological 
complex becomes hydrophobic due to cleavage of a part of the 
fluorescent dye. Such hydrophobic complex can aggregate and readily be 
separated and removed from the biological mixture. The technology can 
be used in a broad range of applications, such as environmental or food 
(removal of contaminants from samples), or in vivo removal of toxins, 
pathogens or drugs from a subject, where the latter may provide a 
photo-controlled way to control the pharmacokinetics of a drug in vivo. 
The technology can also be applied in the therapeutic field, for 
example in cancer therapy, by killing and removal of tumor cells in a 
subject with the aid of wearable NIR device. In such treatment, the 
aggregated target cells may be removed from the subject via the liver 
and/or spleen.
    Potential Commercial Applications:
     Environmental or food (removal of contaminants from 
samples)
     In vivo removal of toxins, pathogens or drugs from a 
subject
     Cancer therapy
    Competitive Advantages: Simple and versatile way to separate and 
remove molecules or cells from a complex mixture.
    Development Stage: Early-stage
    Inventors: Hisataka Kobayashi, et al. (NCI)
    Intellectual Property: HHS Reference No. E-209-2014/0--US 
Provisional Application No. 62/034,990 filed 08 August 2014
    Licensing Contact: Uri Reichman, Ph.D., MBA; 301-435-4616; 
[email protected]
    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. For collaboration opportunities, please contact John 
D. Hewes, Ph.D. at [email protected].

Human Monoclonal Antibodies Against 5T4 as Therapeutic Agents

    Description of Technology: 5T4 is an antigen expressed in a number 
of carcinomas. Its expression is limited in normal tissue, but is 
prevalent in malignant tumors throughout their development. This 
confined expression makes it an attractive target for cancer 
immunotherapy. 5T4 is often found in colorectal, ovarian, and gastric 
tumors and thus has been used as a prognostic aid for these cancers. In 
addition, its role in antibody-directed immunotherapy for delivering 
response modifiers to tumors has been studied using murine monoclonal 
antibodies (mAbs) and the cancer vaccine TroVax (currently in clinical 
trials for multiple solid tumors) targets 5T4.
    The present invention describes the identification and 
characterization of two fully human mAbs (m1001 and m1002) that bind to 
5T4. Since the mAbs are fully human, they could have less 
immunogenicity and better safety profiles than the existing mouse and 
humanized antibodies. These mAbs have the potential to be cancer 
therapeutics as naked mAbs, Chimerica Antigen Receptors (CARs) and/or 
Antibody-Drug Conjugates (ADCs).
    Potential Commercial Applications: A mAb, CAR, or ADC therapeutic 
for the

[[Page 61879]]

treatment of various human cancers expressing 5T4.
    Competitive Advantages:
     The fully human antibodies may have better drugability, 
especially less immunogenicity and better safety.
     This antibodies could be used as naked mAbs, CARs and/or 
as ADCs.
     The confined expression of 5T4 makes it an attractive 
target for cancer immunotherapy.
     5T4 mAbs could be used to treat several solid tumor 
cancers.
    Development Stage: In vitro data available
    Inventors: Dimiter Dimitrov, Tianlei Ying, Yang Feng (all of NCI)
    Intellectual Property: HHS Reference No. E-158-2014/0--U.S. 
Provisional Application No. 62/034,995 filed 08 August 2014
    Licensing Contact: Whitney Hastings; 301-451-7337; 
[email protected]

Quantitative Multiplex Methods for Rapid Detection and Identification 
of Viral Nucleic Acids

    Description of Technology: The subject technologies are 
quantitative multiplex loop mediated isothermal amplification assays 
that can detect and distinguish different viral pathogens, including 
HIV, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Hepatitis E 
Virus (HEV), Dengue Virus (DENV), Chikungunya virus (CHIKV) and West 
Nile Virus (WNV). The assay has the advantage of distinguishing between 
different genotypes of HCV. It has the potential to detect other 
pathogens. A quantitative multiplex variation of the assay can detect 
and identify all seven viruses using one reaction mixture. The 
detection-reaction is performed on a simple heat-source and viral 
quantitation can be measured using a simple fluorospectrophotometer. 
The entire detection process using these assays can be accomplished 
within 30 to 60 minutes in a doctor's office, laboratory setting, or in 
the field. Detection limits of as little as 1-10 International Units 
(viral copies) are possible with the use of fluorogenic 
oligonucleotides. The assays demonstrate very high specificity when 
tested with human clinical samples.
    Potential Commercial Applications: Detection assays for viral 
pathogens such as HIV, HBV, HCV, HEV, Dengue Virus, Chikungunya, and 
West Nile Virus.
    Competitive Advantages:
     Assays can be completed within 30 to 60 minutes and in a 
doctor's office, laboratory setting, or in the field.
     Assays can be performed without expensive instrumentation 
or specialized technical operators.
     Assays are highly specific and can distinguish between 
different viruses and between different genotypes of viruses.
    Development Stage:
     Early-stage
     In vitro data available
     In vivo data available (human)
    Inventors: Dougbeh-Chris Nyan (FDA), Deborah R. Taylor (FDA), Maria 
Rios (FDA), Kevin L. Swinson (Morgan State University), Laura E. 
Ulitzky (FDA)
    Publication: Nyan DC, et al. Rapid Detection of Hepatitis B Virus 
in Blood Plasma by a Specific and Sensitive Loop-Mediated Isothermal 
Amplification Assay. Clin Infect Dis. 2014 July 1;59(1):16-23. [PMID 
24704724]
    Intellectual Property: HHS Reference No. E-135-2014/0--US 
Provisional Patent Application No. 61/979,446 filed 14 April 2014
    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
[email protected]
    Collaborative Research Opportunity: The Food and Drug 
Administration, Center for Biologics Evaluation and Research, is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate or commercialize 
blood screening test and/or diagnostic test for infectious diseases. 
For collaboration opportunities, please contact Nisha Narayan at 
[email protected] or 240-402-9770.

    Dated: October 8, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-24403 Filed 10-14-14; 8:45 am]
BILLING CODE 4140-01-P