[Federal Register Volume 73, Number 31 (Thursday, February 14, 2008)]
[Notices]
[Pages 8704-8705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2749]


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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.

Use of Amyloid Proteins as Vaccine Scaffolds

    Description of Technology: Amyloid proteins are composed of 
peptides whose chemical properties are such that they spontaneously 
aggregate in vitro or in vivo, assuming parallel or antiparallel beta 
sheet configurations. Amyloid proteins can arise from peptides which, 
though differing in primary amino acid sequences, assume the same 
tertiary and quaternary structures. The amyloid structure presents a 
regular array of accessible N-termini of the peptide molecules.
    Claimed in this application are compositions and methods for use of 
amyloid proteins as vaccine scaffolds, on which peptide determinants 
from microorganisms or tumors may be presented to more efficiently 
generate and produce a sustained neutralizing antibody response to 
prevent infectious diseases or treat tumors. The inventors have arrayed 
peptides to be optimally immunogenic on the amyloid protein scaffold by 
presenting antigen using three different approaches. First, the N-
terminal ends of the amyloid forming peptides can be directly modified 
with the peptide antigen of interest; second, the N-termini of the 
amyloid forming peptides are modified with a linker to which the 
peptide antigens of interest are linked; and third, the scaffold 
amyloid may be modified to create a chimeric molecule.
    Aside from stability and enhanced immunogenicity, the major 
advantages of this approach are the synthetic nature of the vaccine and 
its low cost. Thus, concerns regarding contamination of vaccines 
produced from cellular substrates, as are currently employed for some 
vaccines, are eliminated; the robust stability allows the amyloid based 
vaccine to be stored at room temperature for prolonged periods of time; 
and the inexpensive synthetic amino acid starting materials, and their 
rapid spontaneous aggregation in vitro should provide substantial cost 
savings over the resource and labor-intensive current vaccine 
production platforms.
    Application: Immunization to prevent infectious diseases or treat 
chronic conditions or cancer.
    Developmental Status: Vaccine candidates have been synthesized and 
preclinical studies have been performed.
    Inventors: Amy Rosenberg (CDER/FDA), James E. Keller (CBER/FDA), 
Robert Tycko (NIDDK).
    Patent Status: U.S. Provisional Application No. 60/922,131 filed 06 
Apr 2007 (HHS Reference No. E-106-2007/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Peter A. Soukas, JD; 301-435-4646; 
[email protected].
    Collaborative Research Opportunity: The FDA, Division of 
Therapeutic Proteins (CDER) and Office of Vaccines, Division of 
Bacterial Products (CBER) is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize amyloid based vaccines for 
prevention of infectious disease or treatment of malignant states. 
Please contact Amy Rosenberg at [email protected] or (301) 827-
1794 for more information.

Inhibiting HIV Infection Using Integrin Antagonists

    Description of Technology: Infection with HIV depletes and impairs 
CD4 cells, a key component of the immune system. Effective therapies 
such as highly active antiretroviral therapy (HAART) have focused on 
preserving CD4 cells. However, long term HAART has significant toxicity 
associated with it. The current technology describes the use of 
integrin antagonists as an alternative to treating or preventing HIV 
infection and replication. Specifically, [alpha]4 integrin plays a role 
in directing lymphocytes to the primary site of HIV replication. 
Inhibition of the interaction of [alpha]4[beta]1 or [alpha]4[beta]7 
with gp120 can therefore be important in the development of effective 
HIV treatments.
    Applications: Inhibiting HIV infection; Inhibiting HIV replication.
    Development Status: In vitro data.
    Inventors: James Arthos, Diana Goode, Claudia Cicala, and Anthony 
Fauci (NIAID).
    Patent Status:

U.S. Patent Application No. 60/873,884 filed 07 Dec 2006 (HHS Reference 
No. E-055-2007/0-US-01)
U.S. Patent Application No. 60/920,880 filed 03 Mar 2007 (HHS Reference 
No. E-055-2007/1-US-01)
U.S. Patent Application No. 60/957,140 filed 21 Aug 2007 (HHS Reference 
No. E-055-2007/2-US-01)
PCT Patent Application No. PCT/US2007/086663 filed 06 Dec 2007 (HHS 
Reference No. E-055-2007/3-PCT-01)

    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Susan Ano, PhD; 301-435-5515; [email protected].
    Collaborative Research Opportunity: The NIAID Laboratory of 
Immunoregulation is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize this technology. Please contact Dr. James 
Arthos at 301-435-2374 for more information.

Coacervate Microparticles Useful for the Sustained Release 
Administration of Therapeutics Agents

    Description of Technology: The described technology is a 
biodegradable microbead or microparticle, useful for the sustained 
localized delivery of biologically active proteins or other molecules 
of pharmaceutical interest. The microbeads are produced from several 
USP grade materials, a cationic polymer, an anionic polymer and a 
binding component (e.g., gelatin, chondroitin sulfate and avidin), in 
predetermined ratios. Biologically active proteins are incorporated 
into preformed microbeads via an introduced binding moiety under 
nondenaturing conditions.

[[Page 8705]]

    Proteins or other biologically active molecules are easily 
denatured, and once introduced into the body, rapidly cleared. These 
problems are circumvented by first incorporating the protein into the 
microbead. Microbeads with protein payloads are then introduced into 
the tissue of interest, where the microbeads remain while degrading 
into biologically innocuous materials while delivering the protein/drug 
payload for adjustable periods of time ranging from hours to weeks. 
This technology is an improvement of the microbead technology described 
in U.S. Patent No. 5,759,582.
    Applications: This technology has two commercial applications. The 
first is a pharmaceutical drug delivery application. The bead allows 
the incorporated protein or drug to be delivered locally at high 
concentration, ensuring that therapeutic levels are reached at the 
target site while reducing side effects by keeping systemic 
concentration low. The microbead accomplishes this while protecting the 
biologically active protein from harsh conditions traditionally 
encountered during microbead formation/drug formulation.
    The microbeads are inert, biodegradable, and allow a sustained 
release or multiple-release profile of treatment with various active 
agents without major side effects. In addition, the bead maintains 
functionality under physiological conditions.
    Second, the microbeads and microparticles can be used in various 
research assays, such as isolation and separation assays, to bind 
target proteins from biological samples. A disadvantage of the 
conventional methods is that the proteins become denatured. The 
denaturation results in incorrect binding studies or inappropriate 
binding complexes being formed. The instant technology corrects this 
disadvantage by using a bead created in a more neutral pH environment. 
It is this same environment that is used for the binding of the protein 
of interest as well.
    Inventor: Phillip F. Heller (NIA).
    Patent Status:

U.S. Provisional Application No. 60/602,651 filed 19 Aug 2004 (HHS 
Reference No. E-116-2004/0-US-01)
PCT Application No. PCT/US2005/026257 filed 25 Jul 2005, which 
published as WO 2006/023207 on 02 Mar 2006 (HHS Reference No. E-116-
2004/0-PCT-02)
U.S. Patent Application No. 11/659,976 filed 12 Feb 2007 (HHS Reference 
No. E-116-2004/0-US-03)

    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Susan O. Ano, PhD; 301/435-5515; 
[email protected].

    Dated: February 7, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E8-2749 Filed 2-13-08; 8:45 am]
BILLING CODE 4140-01-P