[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
(CB1) receptors in brains of mammals, particularly humans,
using positron emission tomography (PET) or single photon emission
computed tomography
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(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;
[email protected].
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, [email protected].
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 [email protected] 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, [email protected].
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
[email protected] 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; [email protected].
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
[email protected] 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