[Federal Register Volume 70, Number 149 (Thursday, August 4, 2005)]
[Notices]
[Pages 44931-44934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15346]


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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

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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.

Immunogenic Peptides From Human Papillomavirus Type 16 E2

Samir N. Khleif and Jiahua Qian (NCI).
U.S. Provisional Application No. 60/671,463 filed 15 Apr. 2005 (DHHS 
Reference No. E-155-2005/0-US-01).
U.S. Provisional Application No. 60/680,000 filed 12 May 2005 (DHHS 
Reference No. E-155-2005/1-US-01).
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Available for licensing, commercial development and biological 
materials licensing are CD8+ T cell epitopes from HPV16 E2 (Human 
Papillomavirus serotype 16 E2). These epitopes generated from amino 
acid positions 69-77 (ALQAIELQL) and 138-147 (YICEEASVTV) bind to 
HLA.A2 and elicit CD8+ cytotoxic T cell responses that lyse tumor cells 
of low-grade cervical neoplasia (wart).
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

HIV gp41-Membrane Proximal Region Arrayed on Hepatitis B Surface 
Antigen Particles for HIV Diagnostic and Vaccine Applications

Richard T. Wyatt (NIAID), Sanjay K. Phogat (NIAID), Ira Berkower (FDA).
U.S. Provisional Application No. 60/653,930 filed 18 Feb. 2005 (DHHS 
Reference No. E-123-2005/0-US-01).
Licensing Contact: Susan Ano; 301/435-5515; [email protected].

    This technology describes vectors encoding the membrane proximal 
region (MPR) and select variants from HIV-1 gp41 linked to the 
hepatitis B surface antigen (HBsAg) and the resulting expressed 
particles for use in HIV diagnostic and vaccine applications. HIV-1 
gp41 membrane proximal region contains two epitopes recognized by 
broadly neutralizing human monoclonal antibodies 2F5 and 4E10. However, 
immunization with gp41 MPR or the 2F5 or 4E10 epitopes have failed to 
raise neutralizing antibodies. In the subject technology, the particles 
were shown to bind antibodies from broadly neutralizing human sera and 
to the two known broadly neutralizing antibodies 2F5 and 4E10 with high 
relative affinities, demonstrating that the relevant epitopes are 
accessible for antibody binding and the potential utility of the 
particles in diagnostic applications. Additionally, these particles 
could be used to screen phage-display libraries for novel broadly 
cross-reactive neutralizing antibodies, of which only five are 
currently known. These particles could also be used for selection of 
MPR specific B cells. Lastly, these particles have been shown to be 
immunogenic and raise antibodies that recognize HIV-1 Env gp160 
expressed on the cell surface. These immunogens can elicit neutralizing 
antibodies specific for HIV gp41 MPR, the MPR of gp41 is highly 
conserved across various HIV clades and therefore is likely to generate 
broadly neutralizing antibodies when administered in a proper 
presentation in a lipid context as is the case in HBsAg particles. 
Multiple copies of the MPR of HIV-1 gp41 arrayed on the particles could 
significantly increase the immunogenic potential compared to monomeric 
molecules. An increase of this nature has been observed with HBsAg and 
HPV virus-like particles in hepatitis B and cervical cancer vaccines, 
respectively, suggesting that particulate array may improve the 
presentation of selected epitopes to the immune system.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

North-2'-Deoxy-Methanocarbathymidines as Antiviral Agents Against 
Poxviruses

Christopher K. Tseng (NIAID), Victor E. Marquez (NCI).
U.S. Provisional Application No. 60/684,811 filed 25 May 2005 (DHHS 
Reference No. E-047-2005/0-US-01).
Licensing Contact: Robert M. Joynes; 301/594-6565; 
[email protected].

    This invention relates to a method for the prevention or treatment 
of poxvirus infection by administering an effective amount of an 
antiviral agent comprising a carbocyclic 2'-deoxynucleoside analog (as 
described in U.S. Patent Nos. 5,629,454 and 5,869,666) to an individual 
in need thereof. North-methanocarbathymidine (N-MCT), a thymidine 
analog with a pseudosugar moiety locked in the northern conformation, 
which was previously shown to exert strong activity against herpes 
simplex virus types 1 and 2, has been identified as exhibiting potent 
activity against poxviruses. N-MCT effectively blocks poxvirus 
synthesis through its phosphorylated metabolite, which is more 
efficiently produced in poxvirus-infected cells. This compound is 
approximately seven times more potent than cidofovir against vaccinia 
and cowpox in cell culture. The higher potency and target specificity 
of N-MCT against poxvirus, as well as its high margin of safety, makes 
it a highly desirable agent against the poxviridae family. In addition, 
the mechanism of N-MCT may be different from that of cidofovir, making 
it even more desirable due to the scarcity of the potential available 
efficacious anti-pox agents currently under development. This method of 
treating poxvirus with the described analogs is now available for 
licensing.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

A Novel Interleukin-12 (IL-12) Inducing Protein Isolated from 
Toxoplasma gondii Inflammatory Profilin (TGIP)

Alan Sher and Felix Yarovinsky (NIAID).
U.S. Provisional Application 60/641,429 filed 06 Jan 2005 (DHHS 
Reference No. E-046-2005/0-US-01).
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Available for licensing and commercial development is a patent 
pending technology for identifying and isolating a novel interleukin-12 
(IL-12) inducing protein isolated from Toxoplasma gondii (T. gondii), 
and to methods of using this protein for modulating immune responses. 
Interferon-[gamma] (IFN-[gamma]) is critical in host resistance to many 
pathogens and also has potent anti-tumor effects on certain IFN-[gamma] 
sensitive tumors. IL-12 triggers the synthesis of IFN-[gamma], thus 
compounds that stimulate IL-12 production are likely to contribute to 
stimulation of host resistance to pathogens and IFN-[gamma] sensitive 
tumors.
    The isolated protein, Toxoplasma gondii Inflammatory Profilin 
(TGIP), also known as PFTG (Profilin Toxoplasma gondii) binds to Toll-
like receptor 11 (TLR 11) and induces dendritic cell IL-12 production. 
The patent as filed discloses isolated TGIP polypeptide sequences, 
fusion proteins comprising a TGIP and antigen polypeptide portions, 
isolated nucleic acids encoding a fusion protein, and a promoter-linked 
polynucleotide encoding TGIP. Also described are methods for inducing a 
IL-12 response, a method for administering isolated TGIP for the 
treatment of pathogenic infection, a method for treating an IFN-

[[Page 44933]]

[gamma] sensitive cancer in a subject and methods for enhancing immune 
response against an antigen in a subject. Also with the scope of the 
invention are anti-TGIP antibodies. Since IL-12 also has other 
immunostimulatory effects, further identification of IL-12 inducing 
compounds will be useful for the design of immunostimulatory and 
adjuvant agents.
    This research is described in Yarovinsky et al., ``LR11 activation 
of dendritic cells by a protozoan profilin-like protein,'' Science 2005 
Jun 10; 308(5728):1626-9. Epub 2005 Apr 28.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Ultrahigh-Resolution Fiber-Optic Confocal Microscope And Method

Ilko Ilev (FDA/CDRH), Ronald Waynant (FDA/CDER), Israel Gannot (NICHD), 
Amir Gandjbakhche (NICHD).
U.S. Provisional Application No. 60/671,104 filed 14 Apr. 2005 (DHHS 
Reference No. E-038-2005/0-US-01).
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Public Health Service investigators have invented a single-mode 
fiber-optic confocal microscope for which a licensee and commercial 
developer is sought. The ultrahigh-resolution fiber-optic confocal 
microscope has an illumination system; three single-mode optical 
fibers, each optically coupled to a fiber coupler; a sample support 
stage arranged to receive illumination radiation from an end of one of 
the single-mode optical fibers; a detector arranged to receive output 
radiation from one of the single-mode optical fibers; and a lock-in 
amplifier electrically connected to the detector and the illumination 
system. The illumination system is adapted to provide illumination 
radiation that has a time-varying strength correlated with the detector 
by the lock-in amplifier. The invention provides improved methods and 
designs for confocal microscopy.

Integrin Alpha-V Beta-3 Antagonists for Use in Imaging and Therapy

S. Narasimhan Danthi et al. (CC).
U.S. Patent Application No. 10/911,988 filed 04 Aug 2004 (DHHS 
Reference No. E-170-2004/0-US-01).
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Available for licensing are compounds as shown below for imaging 
and therapy. These compounds are integrin 
[agr]v[bgr]3 receptor antagonists and are 
described and claimed in a patent application available for review. The 
patent application also includes claim coverage for the administration 
of these compounds containing a detectable moiety or pharmaceutical 
compositions of such imaging agents as part of the imaging of cells 
that express integrin [agr]v[bgr]3.
in which: X is either NH, O, or S; n is zero or a positive integer; 
R1 is either CH2, NH, O, or S; R2 is 
either CHR7, NR7, O, or S, in which R7 
is H or alkyl; R3 and R4, which are either the 
same or different from each other, are either H, alkyl, aryl, 
arylalkyl, cycloalkyl, cycloalkylalkyl, alkyl-substituted aryl, 
(alkylsubstitutedaryl)alkyl, hydroxy-substituted alkyl, hydroxy-
substituted aryl, or (hydroxy-substituted aryl)alkyl; R5 is 
either CH2, NH, O, or S; and R6 is either H or 
C(=Y)-R8-R9, in which: Y is either NH, O, or S; 
R8 is either CHR10, NR10, O, or S, in 
which R10 is H or alkyl; and R9 is either H, 
alkyl, aryl, arylalkyl, cycloalkyl, cycloalkylalkyl, alkylsubstituted 
aryl, (alkyl-substituted aryl)alkyl, hydroxy-substituted alkyl, 
hydroxy-substituted aryl, or (hydroxy-substituted aryl)alkyl.
[GRAPHIC] [TIFF OMITTED] TN04AU05.001



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    Dated: July 19, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-15346 Filed 8-3-05; 8:45 am]
BILLING CODE 4140-01-P