Notice: Government-Owned Inventions; Availability for Licensing

Federal Register: April 29, 2008 (Volume 73, Number 83)              
                  Page 23255-23256

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.

Assay for Identification of Influenza-Neutralizing Antibodies

    Description of Technology: Development of effective vaccines 
against influenza, especially pandemic or avian, is a subject of 
intense current research efforts. The efficacy of these vaccines has 
historically been assessed using hemagglutination inhibition (HAI) 
assays. However, HAI assays are limited in their utility by lack of 
standardization amongst laboratories. The NIH is pleased to offer the 
subject technology, a system to quantitate virus neutralization and 
entry. This system utilizes pseudotyped lentiviral vectors that mimic 
properties of the influenza virus. Experimental use of this system has 
shown an increase in sensitivity more than ten times that achieved with 
HAI assays. This standardized system can allow influenza vaccine 
candidates to be evaluated and compared, which can be a critical step 
in identifying the best product forward.
    Applications: Quick, high-throughput, sensitive and quantitative 
measure of neutralizing antibodies for vaccine development; 
Identification of therapeutic monoclonal antibodies.
    Advantages: Standardized assay, unlike currently utilized assays; 
Generation of comparable data for various vaccine candidates.
    Development Status: Comparative data against current standard 
available.
    Inventors: Gary Nabel and Zhi-yong Yang (NIAID).
    Patent Status: U.S. Provisional Application No. 60/993,378 filed 11 
Sept 2007 (HHS Reference No. E-323-2007/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Susan Ano, Ph.D.; 301-435-5515; 
anos@mail.nih.gov.

Influenza Vaccines, Therapeutics, and Monoclonal Antibodies

    Description of Technology: Concerns about a potential influenza 
pandemic and its prevention are a regular part of health news, with 
bird (avian) influenza (prominently including H5N1 strains) being a 
major concern. Vaccination is one of the most effective ways to

[[Page 23256]]

minimize suffering and death from influenza. Currently, there is not an 
effective way to vaccinate against avian influenza without knowing what 
subtype and strain will circulate. Described here are two technologies 
with application to development of vaccines against influenza as well 
as therapeutics and monoclonal antibodies. One technology provides for 
development of potentially broadly protective influenza vaccines, while 
the other seeks to improve immune response to the vaccine through 
increased receptor affinity.
    The first technology offers candidate DNA vaccines that were 
primarily designed to elicit neutralizing antibodies to target H5N1, 
H1N1, H3N2 and other subtypes of influenza. The candidate vaccines 
express H/HA or neuramidase (N/NA) protein that has been codon 
optimized and/or modified at the protease cleavage site. The modified 
genes could be used in DNA vaccines, in viral vectors, recombinant 
proteins/particles or combination. Exemplary animal studies use 
proprietary expression systems that increase protein expression 
relative to commonly used alternatives. This invention potentially 
provides a vaccine strategy for controlling influenza epidemics, 
including avian flu, should it cross over to humans; the 1918 strain of 
flu; and seasonal flu strains. In addition, this invention is designed 
to lead to a combination vaccine to provide a broadly protective 
vaccine.
    The second technology relates to H5N1 influenza vaccine candidates 
in which mutations have been introduced to increase affinity of the 
hemagglutinin (H or HA) for the sialic acid receptor found in humans, 
which have a different sialic acid linkage than the corresponding avian 
receptor. These mutations could therefore result in a higher immune 
response in vaccines, producing a more robust response than other H5N1 
vaccine candidates that retain their avian receptor preferences. These 
mutations also changed antibody-sensitivity of the vaccine candidates. 
The H5 modifications can be expressed from DNA or adenoviral vectors, 
or the proteins themselves can be administered. Additionally, these 
mutated HAs can be used to develop therapeutic monoclonal antibodies. 
The technology describes three (3) unique monoclonal antibodies that 
react with wild-type H5, wild-type H5 and mutant HA equivalently, and 
the mutant HA, respectively.
    Applications and Advantages: Influenza vaccine for pandemic or 
epidemic application; Therapeutic antibodies; Potential for combination 
vaccine for broad protection, removing need for seasonal strain 
monitoring; DNA vaccines are easy to produce and store; No risk of 
reversion to pathogenic strain as with live-attenuated virus vaccines.
    Development Status Highlights: Phase I clinical trial active for 
DNA vaccine candidate encoding H5, Indonesian strain (VRC-AVIDNA-036-
00VP); Animal (mouse) data available; Codon optimized for expression in 
human cells.
    Publications:
    1. Certain aspects of this technology were published in: WP Kong et 
al. Protective immunity to lethal challenge of the 1918 pandemic 
influenza virus by vaccination. Proc Natl Acad Sci USA. 2006 Oct 
24;103(43):15987-15991.
    2. GJ Nabel. Gene-based influenza vaccines: a look to the future. 
Presentation to World Health Organization (WHO), February 2007; 
available online at http://www.who.int/vaccine_research/diseases/
influenza/160207_Nabel.pdf.
    Inventors: Gary J. Nabel et al. (VRC/NIAID).
    Patent Status:
    PCT patent application, serial number PCT/US2007/004506 
(publication number WO 2007/100584), filed 16 Feb 2007 with priority to 
16 Feb 2006 (HHS Reference No. E-116-2006/1-PCT-01).
    PCT patent application, serial number PCT/US2007/081002, filed 10 
Oct 2007 with priority to 10 Oct 2006 (HHS Reference No. E-306-2006/4-
PCT-01).
    Related Technology: U.S. Patent No. 7,094,598 issued 22 Aug 2006 
(HHS Reference No. E-241-2001/1-US-01) and associated foreign rights 
(proprietary expression system with CMV/R promoter).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Susan Ano, PhD; 301-435-5515; anos@mail.nih.gov.

Polypeptides for Eliciting Neutralizing Antibodies Against HIV

    Description of Technology: The technology describes conjugate 
polypeptide compositions that are designed to elicit antibody response 
against HIV. The peptides are conjugates of one gp41 capable of forming 
a stable coiled-coil structure and another gp41 capable of forming an 
alpha-helical structure. These structural elements of gp41 were 
identified as important for playing a role in HIV-1 cell entry. 
Compositions that elicit neutralizing antibodies against HIV have been 
elusive to date, but the subject technology may be important in 
realizing that goal.
    Applications: HIV vaccines; Neutralizing antibodies against HIV.
    Development Status: Animal (rabbit and/or guinea pig) data 
available.
    Inventors: Carol Weiss (FDA).
    Patent Status: U.S. Patent 7,311,916 issued 28 Dec 2007 (HHS 
Reference No. E-212-2001/0-US-11).
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Susan Ano, PhD; 301-435-5515; anos@mail.nih.gov.
    Collaborative Research Opportunity: The FDA/CBER Laboratory of 
Immunology is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize this technology. Please contact Carol Weiss at 
carol.weiss@fda.hhs.gov for more information.

    Dated: April 21, 2008.
David Sadowski,
Deputy Director,Division of Technology Development and Transfer,Office 
of Technology Transfer,National Institutes of Health.
 [FR Doc. E8-9257 Filed 4-28-08; 8:45 am]

BILLING CODE 4140-01-P