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


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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, Public Health Service, 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. 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 
(CB<INF>1</INF>) 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 CB<INF>1</INF> 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:
    <bullet> In vivo imaging of CB<INF>1</INF> receptor in mammals, 
particularly humans
    <bullet> Diagnostic imaging of CB<INF>1</INF> receptors in subjects 
having a neurological, neuropsychiatric, neurodegenerative or other 
condition and treatment
    <bullet> Pharmaceutical composition
    <bullet> Diagnostic kits
    Advantages: The principal radioligand under the claim is effective 
for imaging CB<INF>1</INF> 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 CB<INF>1</INF> 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 
(CB<INF>1</INF>) 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 (CB<INF>1</INF>) receptors. J Med Chem., in 
press.
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: RC Tang, JD, LLM; 301-435-5031; 
<a href="/cdn-cgi/l/email-protection#8afeebe4edf8e9cae7ebe3e6a4e4e3e2a4ede5fc"><span class="__cf_email__" data-cfemail="6a1e0b040d18092a070b030644040302440d051c">[email protected]</span></a>.

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:
    <bullet> Has potential to elicit broad neutralizing antibodies 
against several HIV isolates from different clades.
    <bullet> 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.
    <bullet> 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, <a href="/cdn-cgi/l/email-protection#efa79abcaf828e8683c1818687c1888099"><span class="__cf_email__" data-cfemail="8bc3fed8cbe6eae2e7a5e5e2e3a5ece4fd">[email protected]</span></a>.
    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 <a href="/cdn-cgi/l/email-protection#8ae2effdeff9e0cae7ebe3e6a4e4e3e2a4ede5fc"><span class="__cf_email__" data-cfemail="d2bab7a5b7a1b892bfb3bbbefcbcbbbafcb5bda4">[email protected]</span></a> 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:
    <bullet> Human monoclonal antibody, thus eliminating some of the 
issues associated with humanized or murine monoclonal antibodies.
    <bullet> Potential neutralization of HIV-1 primary isolates from 
different clades at nM concentrations.
    <bullet> 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, <a href="/cdn-cgi/l/email-protection#f3bb86a0b39e929a9fdd9d9a9bdd949c85"><span class="__cf_email__" data-cfemail="c088b59380ada1a9aceeaea9a8eea7afb6">[email protected]</span></a>.
    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 
<a href="/cdn-cgi/l/email-protection#9bf3feecfee8f1dbf6faf2f7b5f5f2f3b5fcf4ed"><span class="__cf_email__" data-cfemail="234b4654465049634e424a4f0d4d4a4b0d444c55">[email protected]</span></a> 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:
    <bullet> The vaccine is substantially monomeric but does not tend 
to self-associate and form aggregates.
    <bullet> The antigen fusion proteins retain immunogenicity.
    <bullet> The associated, new manufacturing process provides an 
inexpensive means of making an effective vaccine.
    <bullet> The method eliminates the need for mixing components that 
is the case with competitive technology.
    Applications:
    <bullet> An effective vaccine is needed where plague is endemic.
    <bullet> 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; <a href="/cdn-cgi/l/email-protection#f98d9198959198949ab994989095d7979091d79e968f"><span class="__cf_email__" data-cfemail="106478717c78717d73507d71797c3e7e79783e777f66">[email protected]</span></a>.
    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 
<a href="/cdn-cgi/l/email-protection#4d20242121283f202c3f2a0d23242c242963232425632a223b"><span class="__cf_email__" data-cfemail="066b6f6a6a63746b67746146686f676f6228686f6e28616970">[email protected]</span></a> 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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