Government-Owned Inventions; Availability for Licensing, 50830-50832 [E8-19917]

Download as PDF jlentini on PROD1PC65 with NOTICES 50830 Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices a reduction of toxicity by more than 100,000-fold. Sandwich ELISA analysis indicated that the featured toxoids were two- to three-fold less antigenic than the native neurotoxin compared to commercially available toxoids, which were about 100-fold less antigenic. Preclinical studies have been performed using the toxoids of the invention. Mice were immunized twice, on Day Zero (0) and Day Fourteen (14). By Day Twenty-Eight (28), relatively high toxin-specific IgG titers were detected in animals that had received any of the in-house toxoids, with greater than 99% being IgG1 and the remainder IgG2. These immunized mice remained asymptomatic after being challenged with Fifty (50) to One Million (1,000,000) median lethal dose (LD50) units of the 900 kDa neurotoxin. In contrast, animals immunized with several different batches of commercially available toxoids did not develop measurable toxin-specific antibody titers; however, these mice did survive neurotoxin challenges with Two (2) LD50 units, but died when challenged with Six (6) LD50 units. This application claims the formalindetoxified botulinum compositions described above and an in vitro method for characterizing the toxoids. Also claimed are methods of making the botulinum compositions, and methods of producing antitoxin to botulinum toxin. Applications: ELISA development, production of equine or human-derived botulinum antitoxin, development of next generation botulism vaccines. Development Status: Toxoids have been prepared and preclinical studies have been performed. Standard antibody reagents for ELISA assay development have been prepared. Inventors: James E. Keller (FDA/ CBER). Publication: JE Keller. Characterization of New Formalin Botulinum Neurotoxin Toxoids. Clin Vaccine Immunol. 2008 Jul 30; Epub ahead of print, doi:10.1128/CVI.00117– 08. Patent Status: U.S. Provisional Application No. 61/036,904 filed 14 Mar 2008 (HHS Reference No. E–325–2007/ 0–US–01). Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: Peter A. Soukas, J.D.; 301–435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The FDA Center for Biologics Evaluation and Research is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or VerDate Aug<31>2005 17:36 Aug 27, 2008 Jkt 214001 commercialize botulinum toxoids. Please contact Alice Welch, PhD at 301– 827–0359 or Alice.Welch@fda.hhs.gov for more information. Magnetic Resonance Imaging Methods and Systems for Estimating Cone of Uncertainty Description of Technology: In diffusion tensor MRI imaging it is desirable to determine and display the fiber tract dispersion, e.g., the eigenvectors and the associated uncertainties. For example, the unit eigenvector may be displayed with a cone of uncertainty around its tip. This conveys the notion that the direction of fiber is not known precisely. However, the known methods are directed to computation and visualization of a circular cone of uncertainty. These methods are suitable for practical computation and visualization of an elliptical cone of uncertainty. The current invention overcomes this problem by providing (1) a reconstruction procedure to construct the covariance matrix of a major eigenvector for each voxel of a region of interest of a subject, (2) a visualization technique to visualize the elliptical cone of uncertainty of the eigenvector, and (3) two reconstruction procedures to compute the normalized areal and circumferential measures of the elliptical cone of uncertainty. The methods can be used to diagnose medical disorders associated with anomalous changes in water diffusion. The methods can also be used in applications in material science and earth science (geomagnetism). Applications: Magnetic Resonance Imaging; Diagnostics; Material science; Earth science (Geomagnetism). Inventor: Cheng Guan Koay (NICHD). Publications: 1. CG Koay et al. The elliptical cone of uncertainty and its normalized measures in diffusion tensor imaging. IEEE Trans Med Imaging. 2008 Jun;27(6):834–846. 2. CG Koay et al. Error propagation framework for diffusion tensor imaging via diffusion tensor representations. IEEE Trans Med Imaging. 2007 Aug;26(8):1017–1034. 3. CG Koay et al. A unifying theoretical and algorithmic framework for least squares methods of estimation in diffusion tensor imaging. J Magn Reson. 2006 Sep;182(1):115–125. Patent Status: U.S. Provisional Application No. 60/996,169 filed 05 Nov 2007 (HHS Reference No. E–273– 2007/0–US–01). Licensing Status: Available for licensing. PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 Licensing Contact: Michael A. Shmilovich, Esq.; 301–435–5019; shmilovm@mail.nih.gov. Collaborative Research Opportunity: The NICHD, Section on Tissue Biophysics and Biomimetics, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Alan E. Hubbs, PhD at 301–594– 4263 or hubbsa@mail.nih.gov for more information. Dated: August 18, 2008. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8–19915 Filed 8–27–08; 8:45 am] BILLING CODE 4140–01–P 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: 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. Radiotracers for Imaging Cannabinoid Sub-Type1 (CB1) Receptor Description of Technology: The present invention relates to novel radiolabeled compounds for imaging cannabinoid sub-type 1 (CB1) receptors in brains of mammals, particularly humans, using positron emission tomography (PET) or single photon emission computed tomography E:\FR\FM\28AUN1.SGM 28AUN1 Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices (SPECT). These radioligands can be used in clinical research, diagnostics, or drug discovery and development, in that, they permit understanding of the role of CB1 receptors in neuropsychiatric disorders such as Parkinson’s disease, Huntington’s disease, Alzheimer’s disease, multiple sclerosis, depression, mood disorder, anxiety, schizophrenia, drug addiction, alcohol disorder, obesity and anorexia. Applications: • In vivo imaging of CB1 receptor in mammals, particularly humans • Diagnostic imaging of CB1 receptors in subjects having a neurological, neuropsychiatric, neurodegenerative or other condition and treatment • Pharmaceutical composition • Diagnostic kits Advantages: The principal radioligand under the claim is effective for imaging CB1 receptors in vivo with PET. Development Status: Primary radioligand has been evaluated in nonhuman primates with PET. Market: Radioligands may be useful for performing drug occupancy studies of CB1 receptors, and for neuropsychiatric studies and investigations with imaging techniques (e.g., PET or SPECT). Patent Status: U.S. Provisional Application No. 61/052,581 filed 12 May 2008 (HHS Reference No. E–155– 2008/0–US–01). Inventors: Victor W. Pike (NIMH), Sean R. Donohue (NIMH), et al. Relevant Publications: 1. SR Donohue, C Halldin, VW Pike. Synthesis and structure-activity relationships (SARs) of 1,5diarylpyrazole cannabinoid type-1 (CB1) receptor ligands for potential use in molecular imaging. Bioorg Med Chem. 2006 Jun 1;14(11):3712–3720. 2. SR Donohue, VW Pike, SJ Finnema, ´ P Truong, J Andersson, B Gulyas, C Halldin. Discovery and labeling of high affinity 3,4-diarylpyrazolines as candidate radioligands for in vivo imaging of cannabinoid subtype-1 (CB1) receptors. J Med Chem., in press. Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: RC Tang, JD, LLM; 301–435–5031; tangrc@mail.nih.gov. jlentini on PROD1PC65 with NOTICES HIV Immunogen and Method of Making and Using Same Description of Technology: The invention describes composition and methods of preventing HIV infection using a truncated version of the HIV gp41 subunit of Env fused to human Fc through a flexible linker as a vaccine immunogen. This immunogen binds several broadly cross-reactive HIV–1 VerDate Aug<31>2005 17:36 Aug 27, 2008 Jkt 214001 neutralizing human monoclonal antibodies recently identified and developed by the inventor’s laboratory, including m44. m44 does not react with self-antigen suggesting that this immunogen may elicit antibodies which are not regulated by tolerance mechanisms, a problem suggested as the cause of failure for some of the gp41based immunogens previously tested. Rabbits immunized with this fusion construct developed broad-neutralizing antibodies against several HIV-isolates from different clades in a cell line/ pseudovirus assay with high titer. Preclinical testing of these novel immunogens in primate models is currently being planned. Applications: Treatment and prevention of HIV infection. Advantages: • Has potential to elicit broad neutralizing antibodies against several HIV isolates from different clades. • Immunogen is based on the gp41 subunit of the HIV Env, a region more conserved than the gp120 subunit of Env and fusion to Fc increases the stability and half-life of the immunogen. • Potentially elicits antibodies that are not regulated by tolerance mechanisms. Development Status: Data can be provided upon request. Market: Preventative or treatment for HIV infection. Inventors: Dimiter S. Dimitrov and Mei-yun Zhang (NCI). Publications: 1. M–Y Zhang, V Choudhry, IA Sidorov, V Tenev, BK Vu, A Choudhary, H Lu, GM Stiegler, HWD Katinger, S Jiang, CC Broder, DS Dimitrov. Selection of a novel gp41-specific HIV–1 neutralizing human antibody by competitive antigen panning. J Immunol Methods 2006 Dec 20;317(1–2):21–30. 2. M–Y Zhang, DS Dimitrov. Novel approaches for identification of broadly cross-reactive HIV–1 neutralizing human monoclonal antibodies and improvement of their potency. Curr Pharm Des. 2007;13(2):203–212. 3. V Choudhry, M–Y Zhang, IA Sidorov, JM Louis, I Harris, AS Dimitrov, P Bouma, F Cham, A Choudhary, SM Rybak, T Fouts, DC Montefiori, CC Broder, GV Quinnan, DS Dimitrov. Cross-reactive HIV–1 neutralizing monoclonal antibodies selected by screening of an immune human phage library against an envelope glycoprotein (gp140) isolated from a patient (R2) with broadly HIV– 1 neutralizing antibodies. Virology 2007 Jun 20;363(1):79–90. 4. M–Y Zhang, BK Vu, A Choudhary, H Lu, M Humbert, H Ong, M Alam, RM Ruprecht, G Quinnan, S Jiang, DC PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 50831 Montefiori, JR Mascola, CC Broder, BF Haynes, DS Dimitrov. Cross-reactive human immunodeficiency virus type 1neutralizing human monoclonal antibody that recognizes a novel conformational epitope on gp41 and lacks reactivity against self-antigens. J Virol. 2008 Jul;82(14):6869–6879. Patent Status: U.S. Provisional Application No. 61/126,662 filed 06 May 2008 (HHS Reference No. E–072– 2008/0–US–01). Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: Sally Hu, Ph.D.; 301–435–5606, HuS@mail.nih.gov. Collaborative Research Opportunity: The National Cancer Institute CCR Nanobiology Program is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact John D. Hewes, Ph.D. at 301– 435–3121 or hewesj@mail.nih.gov for more information. Cross-Reactive Neutralizing Human Domain Antibody Against HIV–1 Description of Technology: The invention describes the first identified anti-HIV human domain antibody (m36), which can potentially be used alone or synergistically with other antiHIV antibodies and antiretroviral drugs as a therapeutic and/or preventative for HIV infection. It targets an epitope whose exposure is enhanced by binding of the HIV receptor CD4 to the HIV envelope glycoprotein (Env). M36 was identified by sequential panning of a newly developed large human VH library against Envs from different HIV– 1 isolates. The antibody can neutralize HIV–1 primary isolates from different clades at low (nM) concentrations and due to its small size (14 kDa) is potentially able to efficiently penetrate lymphoid tissues where the virus replicates. The antibody is fairly well characterized and the inventors are generating derivatives of this antibody to improve the half-life and increase its potency and cross-reactivity. Applications: Treatment and prevention of HIV infections. Advantages: • Human monoclonal antibody, thus eliminating some of the issues associated with humanized or murine monoclonal antibodies. • Potential neutralization of HIV–1 primary isolates from different clades at nM concentrations. • Relatively small size allows for potential efficient penetration into lymphoid tissues. Development Status: In vitro data is available. E:\FR\FM\28AUN1.SGM 28AUN1 50832 Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices jlentini on PROD1PC65 with NOTICES Market: HIV therapeutics and preventatives. Inventors: Dimiter Dimitrov and Weizao Chen (NCI). Publications: 1. MY Zhang et al. Identification of a Novel CD4i human monoclonal antibody Fab that neutralizes HIV–1 primary isolates from different clades. Antiviral Res. 2004 Mar;61(3):161–164. 2. MY Zhang et al. Improved breath and potency of an HIV–1 neutralizing human single-chain antibody by random mutagenesis and sequential antigen panning. J Mol Biol. 2004 Jan 2;335(1):209–219. 3. CC Huang et al. Structure of a V3containing HIV–1 gp120 core. Science 2005 Nov 11; 310(5750):1025–1028. 4. W Chen et al. Construction of a large phage-displayed human antibody domain library with a scaffold based on a newly identified highly soluble, stable heavy chain variable domain. J. Mol Biol. 2008, in press. 5. W Chen et al. Human domain antibodies to conserved sterically restricted regions on gp120 as exceptionally potent cross-reactive HIV– 1 neutralizers. Proc Natl Acad Sci USA., under review. Patent Status: U.S. Patent Application No. 61/019,426 filed 07 Jan 2008 (HHS Reference No. E–043–2008/0–US–01). Licensing Status: This invention is available for exclusive or non-exclusive licensing. Licensing Contact: Sally Hu, Ph.D.; 301–435–5606, HuS@mail.nih.gov. Collaborative Research Opportunity: The National Cancer Institute CCR Nanobiology Program is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize domain antibodies and nanoantibodies against HIV. Please contact John D. Hewes, Ph.D. at 301– 435–3121 or hewesj@mail.nih.gov for more information. • The antigen fusion proteins retain immunogenicity. • The associated, new manufacturing process provides an inexpensive means of making an effective vaccine. • The method eliminates the need for mixing components that is the case with competitive technology. Applications: • An effective vaccine is needed where plague is endemic. • An important biodefense countermeasure against dissemination of weaponized plague is sought. Inventors: David F. Nellis and Steven L. Giardina (NIAID). Relevant Publication: JL Goodin et al. Purification and protective efficacy of monomeric and modified Yersinia pestis capsular F1–V antigen fusion proteins for vaccination against plague. Protein Expr Purif. 2007 May;53(1):63– 79. Patent Status: U.S. Patent Application No. 11/944,230 filed 21 Nov 2008 (HHS Reference No. E–189–2007/0–US–01). Development Status: The technology is in pre-clinical stage of development. Licensing Status: Available for nonexclusive or exclusive licensing. Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301–435–4507; thalhamc@mail.nih.gov. Collaborative Research Opportunity: The NIAID is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this plague vaccine. Please contact Marguerite J. Miller at 301–435–8619 /or millermarg@niaid.nih.gov for more information. Monodisperse and Modified Yersinia pestis Capsular F1–V Antigen Fusion Proteins for Vaccination Against Bubonic and Pneumonic Plague Description of Technology: An effective plague vaccine against Yersinia pestis is currently unavailable in the U.S. The F1–V (fusion of two Y. pestis proteins, the Fraction 1 capsular antigen and a second immunogen called the Vantigen) vaccine of this invention is a monodispersed, mutated form of F1–V fusion protein. This is a promising candidate for commercialization. Features and benefits include: • The vaccine is substantially monomeric but does not tend to selfassociate and form aggregates. BILLING CODE 4140–01–P VerDate Aug<31>2005 17:36 Aug 27, 2008 Jkt 214001 Dated: August 18, 2008. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8–19917 Filed 8–27–08; 8:45 am] DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [Docket No. DHS–2008–0087] Data Privacy and Integrity Advisory Committee Office of the Secretary, DHS. Notice of Federal Advisory Committee Meeting. AGENCY: ACTION: SUMMARY: The Data Privacy and Integrity Advisory Committee will meet on September 17, 2008 in Las Vegas, PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 NV. This meeting will be open to the public. DATES: The Data Privacy and Integrity Advisory Committee will meet on Wednesday, September 17, 2008 from 9 a.m. to 12 p.m. and 1 p.m. to 4:20 p.m. Please note that the meeting may close early if the committee has completed its business. ADDRESSES: The meeting will be held in a conference room in the Hampton Inn Tropicana and Southwest Event Center, 4975 Dean Martin Drive, Las Vegas, NV 89118. Send written materials, comments, and requests to make oral presentations to Ken Hunt, Executive Director, Data Privacy and Integrity Advisory Committee, Department of Homeland Security, Washington, DC 20528. Written materials, comments, and requests to make oral presentations at the meeting should reach the contact person listed by September 8, 2008. Requests to have a copy of your material distributed to each member of the committee prior to the meeting should reach the persons listed under FOR FURTHER INFORMATION CONTACT, below, by September 8, 2008. Persons wishing to make comments or who are unable to attend or speak at the meeting may submit comments at any time. All submissions received must include the docket number DHS–2008–0087 and may be submitted by any one of the following methods: • Federal Rulemaking Portal: https:// www.regulations.gov. Follow instructions for submitting comments on the Web site. • E-mail: PrivacyCommittee@dhs.gov. Include docket number in the subject line of the message. • Fax: (866) 466–5370. • Mail: Mr. Ken Hunt, Executive Director, Data Privacy and Integrity Advisory Committee, Department of Homeland Security, Washington, DC 20528. Instructions: All submissions received must include the words ‘‘Department of Homeland Security Data Privacy and Integrity Advisory Committee’’ and the docket number: DHS–2008–0087. Comments received will also be posted without alteration at https:// www.regulations.gov, including any personal information provided. Docket: For access to the docket to read background documents or comments received by the DHS Data Privacy and Integrity Committee, go to https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Hugo Teufel III, Chief Privacy Officer, or Ken Hunt, Executive Director, Data Privacy and Integrity Advisory Committee, Department of Homeland E:\FR\FM\28AUN1.SGM 28AUN1

Agencies

[Federal Register Volume 73, Number 168 (Thursday, August 28, 2008)]
[Notices]
[Pages 50830-50832]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19917]


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

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.

Radiotracers for Imaging Cannabinoid Sub-Type1 (CB1) Receptor

    Description of Technology: The present invention relates to novel 
radiolabeled compounds for imaging cannabinoid sub-type 1 
(CB1) receptors in brains of mammals, particularly humans, 
using positron emission tomography (PET) or single photon emission 
computed tomography

[[Page 50831]]

(SPECT). These radioligands can be used in clinical research, 
diagnostics, or drug discovery and development, in that, they permit 
understanding of the role of CB1 receptors in 
neuropsychiatric disorders such as Parkinson's disease, Huntington's 
disease, Alzheimer's disease, multiple sclerosis, depression, mood 
disorder, anxiety, schizophrenia, drug addiction, alcohol disorder, 
obesity and anorexia.
    Applications:
     In vivo imaging of CB1 receptor in mammals, 
particularly humans
     Diagnostic imaging of CB1 receptors in subjects 
having a neurological, neuropsychiatric, neurodegenerative or other 
condition and treatment
     Pharmaceutical composition
     Diagnostic kits
    Advantages: The principal radioligand under the claim is effective 
for imaging CB1 receptors in vivo with PET.
    Development Status: Primary radioligand has been evaluated in non-
human primates with PET.
    Market: Radioligands may be useful for performing drug occupancy 
studies of CB1 receptors, and for neuropsychiatric studies 
and investigations with imaging techniques (e.g., PET or SPECT).
    Patent Status: U.S. Provisional Application No. 61/052,581 filed 12 
May 2008 (HHS Reference No. E-155-2008/0-US-01).
    Inventors: Victor W. Pike (NIMH), Sean R. Donohue (NIMH), et al.
    Relevant Publications:
    1. SR Donohue, C Halldin, VW Pike. Synthesis and structure-activity 
relationships (SARs) of 1,5-diarylpyrazole cannabinoid type-1 
(CB1) receptor ligands for potential use in molecular 
imaging. Bioorg Med Chem. 2006 Jun 1;14(11):3712-3720.
    2. SR Donohue, VW Pike, SJ Finnema, P Truong, J Andersson, B 
Gulyas, C Halldin. Discovery and labeling of high affinity 3,4-
diarylpyrazolines as candidate radioligands for in vivo imaging of 
cannabinoid subtype-1 (CB1) receptors. J Med Chem., in 
press.
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: RC Tang, JD, LLM; 301-435-5031; 
tangrc@mail.nih.gov.

HIV Immunogen and Method of Making and Using Same

    Description of Technology: The invention describes composition and 
methods of preventing HIV infection using a truncated version of the 
HIV gp41 subunit of Env fused to human Fc through a flexible linker as 
a vaccine immunogen. This immunogen binds several broadly cross-
reactive HIV-1 neutralizing human monoclonal antibodies recently 
identified and developed by the inventor's laboratory, including m44. 
m44 does not react with self-antigen suggesting that this immunogen may 
elicit antibodies which are not regulated by tolerance mechanisms, a 
problem suggested as the cause of failure for some of the gp41-based 
immunogens previously tested. Rabbits immunized with this fusion 
construct developed broad-neutralizing antibodies against several HIV-
isolates from different clades in a cell line/pseudovirus assay with 
high titer. Preclinical testing of these novel immunogens in primate 
models is currently being planned.
    Applications: Treatment and prevention of HIV infection.
    Advantages:
     Has potential to elicit broad neutralizing antibodies 
against several HIV isolates from different clades.
     Immunogen is based on the gp41 subunit of the HIV Env, a 
region more conserved than the gp120 subunit of Env and fusion to Fc 
increases the stability and half-life of the immunogen.
     Potentially elicits antibodies that are not regulated by 
tolerance mechanisms.
    Development Status: Data can be provided upon request.
    Market: Preventative or treatment for HIV infection.
    Inventors: Dimiter S. Dimitrov and Mei-yun Zhang (NCI).
    Publications:
    1. M-Y Zhang, V Choudhry, IA Sidorov, V Tenev, BK Vu, A Choudhary, 
H Lu, GM Stiegler, HWD Katinger, S Jiang, CC Broder, DS Dimitrov. 
Selection of a novel gp41-specific HIV-1 neutralizing human antibody by 
competitive antigen panning. J Immunol Methods 2006 Dec 20;317(1-2):21-
30.
    2. M-Y Zhang, DS Dimitrov. Novel approaches for identification of 
broadly cross-reactive HIV-1 neutralizing human monoclonal antibodies 
and improvement of their potency. Curr Pharm Des. 2007;13(2):203-212.
    3. V Choudhry, M-Y Zhang, IA Sidorov, JM Louis, I Harris, AS 
Dimitrov, P Bouma, F Cham, A Choudhary, SM Rybak, T Fouts, DC 
Montefiori, CC Broder, GV Quinnan, DS Dimitrov. Cross-reactive HIV-1 
neutralizing monoclonal antibodies selected by screening of an immune 
human phage library against an envelope glycoprotein (gp140) isolated 
from a patient (R2) with broadly HIV-1 neutralizing antibodies. 
Virology 2007 Jun 20;363(1):79-90.
    4. M-Y Zhang, BK Vu, A Choudhary, H Lu, M Humbert, H Ong, M Alam, 
RM Ruprecht, G Quinnan, S Jiang, DC Montefiori, JR Mascola, CC Broder, 
BF Haynes, DS Dimitrov. Cross-reactive human immunodeficiency virus 
type 1-neutralizing human monoclonal antibody that recognizes a novel 
conformational epitope on gp41 and lacks reactivity against self-
antigens. J Virol. 2008 Jul;82(14):6869-6879.
    Patent Status: U.S. Provisional Application No. 61/126,662 filed 06 
May 2008 (HHS Reference No. E-072-2008/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Sally Hu, Ph.D.; 301-435-5606, HuS@mail.nih.gov.
    Collaborative Research Opportunity: The National Cancer Institute 
CCR Nanobiology Program is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize this technology. Please contact John D. 
Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more 
information.

Cross-Reactive Neutralizing Human Domain Antibody Against HIV-1

    Description of Technology: The invention describes the first 
identified anti-HIV human domain antibody (m36), which can potentially 
be used alone or synergistically with other anti-HIV antibodies and 
antiretroviral drugs as a therapeutic and/or preventative for HIV 
infection. It targets an epitope whose exposure is enhanced by binding 
of the HIV receptor CD4 to the HIV envelope glycoprotein (Env). M36 was 
identified by sequential panning of a newly developed large human VH 
library against Envs from different HIV-1 isolates. The antibody can 
neutralize HIV-1 primary isolates from different clades at low (nM) 
concentrations and due to its small size (14 kDa) is potentially able 
to efficiently penetrate lymphoid tissues where the virus replicates. 
The antibody is fairly well characterized and the inventors are 
generating derivatives of this antibody to improve the half-life and 
increase its potency and cross-reactivity.
    Applications: Treatment and prevention of HIV infections.
    Advantages:
     Human monoclonal antibody, thus eliminating some of the 
issues associated with humanized or murine monoclonal antibodies.
     Potential neutralization of HIV-1 primary isolates from 
different clades at nM concentrations.
     Relatively small size allows for potential efficient 
penetration into lymphoid tissues.
    Development Status: In vitro data is available.

[[Page 50832]]

    Market: HIV therapeutics and preventatives.
    Inventors: Dimiter Dimitrov and Weizao Chen (NCI).
    Publications:
    1. MY Zhang et al. Identification of a Novel CD4i human monoclonal 
antibody Fab that neutralizes HIV-1 primary isolates from different 
clades. Antiviral Res. 2004 Mar;61(3):161-164.
    2. MY Zhang et al. Improved breath and potency of an HIV-1 
neutralizing human single-chain antibody by random mutagenesis and 
sequential antigen panning. J Mol Biol. 2004 Jan 2;335(1):209-219.
    3. CC Huang et al. Structure of a V3-containing HIV-1 gp120 core. 
Science 2005 Nov 11; 310(5750):1025-1028.
    4. W Chen et al. Construction of a large phage-displayed human 
antibody domain library with a scaffold based on a newly identified 
highly soluble, stable heavy chain variable domain. J. Mol Biol. 2008, 
in press.
    5. W Chen et al. Human domain antibodies to conserved sterically 
restricted regions on gp120 as exceptionally potent cross-reactive HIV-
1 neutralizers. Proc Natl Acad Sci USA., under review.
    Patent Status: U.S. Patent Application No. 61/019,426 filed 07 Jan 
2008 (HHS Reference No. E-043-2008/0-US-01).
    Licensing Status: This invention is available for exclusive or non-
exclusive licensing.
    Licensing Contact: Sally Hu, Ph.D.; 301-435-5606, HuS@mail.nih.gov.
    Collaborative Research Opportunity: The National Cancer Institute 
CCR Nanobiology Program is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize domain antibodies and nanoantibodies against 
HIV. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
hewesj@mail.nih.gov for more information.

Monodisperse and Modified Yersinia pestis Capsular F1-V Antigen Fusion 
Proteins for Vaccination Against Bubonic and Pneumonic Plague

    Description of Technology: An effective plague vaccine against 
Yersinia pestis is currently unavailable in the U.S. The F1-V (fusion 
of two Y. pestis proteins, the Fraction 1 capsular antigen and a second 
immunogen called the V-antigen) vaccine of this invention is a 
monodispersed, mutated form of F1-V fusion protein. This is a promising 
candidate for commercialization.
    Features and benefits include:
     The vaccine is substantially monomeric but does not tend 
to self-associate and form aggregates.
     The antigen fusion proteins retain immunogenicity.
     The associated, new manufacturing process provides an 
inexpensive means of making an effective vaccine.
     The method eliminates the need for mixing components that 
is the case with competitive technology.
    Applications:
     An effective vaccine is needed where plague is endemic.
     An important biodefense countermeasure against 
dissemination of weaponized plague is sought.
    Inventors: David F. Nellis and Steven L. Giardina (NIAID).
    Relevant Publication: JL Goodin et al. Purification and protective 
efficacy of monomeric and modified Yersinia pestis capsular F1-V 
antigen fusion proteins for vaccination against plague. Protein Expr 
Purif. 2007 May;53(1):63-79.
    Patent Status: U.S. Patent Application No. 11/944,230 filed 21 Nov 
2008 (HHS Reference No. E-189-2007/0-US-01).
    Development Status: The technology is in pre-clinical stage of 
development.
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-
435-4507; thalhamc@mail.nih.gov.
    Collaborative Research Opportunity: The NIAID is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this plague 
vaccine. Please contact Marguerite J. Miller at 301-435-8619 /or 
millermarg@niaid.nih.gov for more information.

    Dated: August 18, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-19917 Filed 8-27-08; 8:45 am]
BILLING CODE 4140-01-P
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