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