E7-14205. 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: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Rational HIV Therapeutic Design

Description of Technology: This technology describes the structural nature of a highly conserved tyrosine-sulfate binding pocket on the HIV-1 gp120 envelope glycoprotein and the use of this information to design HIV-entry inhibitors that target it. The binding pocket was characterized by structural determinations of the N-terminus of CCR5 with gp120 as well as of the complex of 412d (a tyrosine-sulfated antibody) with gp120 and CD4. The N terminus of CCR5, like the 412d antibody, is tyrosine-sulfated. In spite of structural differences between these molecules, gp120 recognizes both tyrosine-sulfated molecules in similar ways, indicating that this specificity can be exploited in the design of HIV-entry inhibitors.

Applications: HIV therapeutic design.

Inventors: Peter D. Kwong et al. (NIAID).

Patent Status: U.S. Provisional Application No. 60/923,498 filed 13 Apr 2007 (HHS Reference No. E-181-2007/0-US-01).

Licensing Contact: Susan Ano, PhD; 301/435-5515; [e-mail].

Collaborative Research Opportunity: The Vaccine Research Center of the National Institute of Allergy and Infectious Diseases as well as the Laboratory of Bioorganic Chemistry of the National Institute of Diabetes and Digestive and Kidney Diseases are seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize tyrosine-sulfated CCR5-based inhibitors of HIV-1 infection. Please contact Susan Ano for more information.

Viral Entry or Replication Inhibitors

Description of Technology: The Tec family of tyrosine kinases, consisting of five family members Tec, Btk, Itk, Rlk, and BMX, are key regulators of signaling pathways of T lymphocytes. Many existing antiviral therapies rely on inhibition of viral replication, which leads to emergence or selection of resistant viruses. The current technology provides an alternative method for prevention or treatment of viral infection through administration of a Tec tyrosine kinase inhibitor. Such inhibitors can be siRNA, small chemical compounds, antisense or antibody. The current technology describes the inhibition of Itk (also known as Emt and Tsk) and the resulting decrease in HIV infectivity, replication, and transcription for exemplary purposes. Importantly, these inhibitors do not affect the expression of HIV co-receptors CCR5, CXCR4, or CD4. The current technology could be used in combination with therapeutics that target virus replication.

Application: Treatment of viral infection.

Development Status: In vitro data available.

Inventors: Julie Readinger et al. (NHGRI).

Patent Status: U.S. Provisional Application No. 60/786,245 filed 29 Mar 2006 (HHS Reference No. E-151-2006/0-US-01); PCT Application No. PCT/US2007/007711 filed 29 Mar 2007 (HHS Reference No. E-151-2006/1-PCT-01).

Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; [e-mail].

Dual Expression DNA Influenza Vaccine

Description of Technology: The NIH is pleased to announce a single vector DNA vaccine against influenza as available for licensing. The single vector expresses both hemagglutinin (HA) and matrix (M) proteins, generating both humoral and cellular immune responses. The vaccine candidate completely protected mice against homologous virus challenge and significantly improved survival against heterologous virus challenge. A robust and reliable vaccine supply is widely recognized as critical for seasonal or pandemic influenza preparedness. The advantages offered by this vaccine make it an excellent candidate for further development.

Advantages: (1) DNA vaccines easy to produce and store; (2) Vaccine candidate improved survival against heterologous virus challenge; (3) No risk of reversion to pathogenic strain as with live-attenuated virus vaccines; (4) Can be administered to immuno-compromised individuals, increasing potential market size; (5) HA and M proteins encoded by single vector, ensuring uniform delivery of immunogen; (6) More efficient to boost synergistic effects on both HA and M specific immune responses than a mixture of individual plasmids; (7) M protein not subject to antigenic drift, which allows advanced manufacturing and overcomes the need for strain monitoring; (8) DNA vaccines elicit cellular immune response, essential for efficient virus clearance.

Application: Influenza vaccine.

Inventors: Zhiping Ye et al. (CBER/FDA).

Patent Status: U.S. Provisional Application No. 60/786,747 filed 27 Mar 2006 (HHS Reference No. E-300-2005/0-US-01); PCT Application No. PCT/US2007/007529 filed 27 Mar 2007 (HHS Reference No. E-300-2005/1-PCT-01).

Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; [e-mail].

Collaborative Research Opportunity: The CBER/FDA Division of Viral Products is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the HA/M single vector DNA vaccine. Please contact Zhiping Ye at 301-435-5197 or [e-mail] for more information.

Peptide Mimotope Candidates for Otitis Media Vaccine

Description of Technology: This technology describes peptide mimotopes of lipooligosaccharides (LOS) from nontypeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis that are suitable for developing novel vaccines against the respective pathogens, for which there are currently no licensed vaccines. The mimotopes not only immunologically mimic LOSs from NTHi and M. catarrhalis but will also bind to antibodies specific for the respective LOS. NTHi and M. catarrhalis are common pathogens that cause otitis media in children and lower respiratory tract infections in adults. The effectiveness of a vaccine could be increased by substitution of a LOS epitope with a peptide mimic. Preliminary experiments have shown that some of the mimic peptides conjugated to a carrier were as effective as their respective LOS-based vaccine in stimulating a humoral immune response in rabbits. A single consensus amino acid sequence was identified for M. catarrhalis, while four such sequences were identified for NTHi. Thus, the identified peptides are promising candidates for developing novel vaccines for NTHi or M. catarrhalis.

Applications: Otitis media vaccine.

Development Status: In vivo data available.

Inventor: Xin-Xing Gu (NIDCD).

Patent Status: U.S. Patent Application No. 11/187,419 filed 22 Jul 2005 (HHS Reference No. E-344-2002/0-US-03).

Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; [e-mail].

Collaborative Research Opportunity: The NIDCD Vaccine Research Section is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Peptide vaccines derived from LOS of NTHi or M. catarrhalis. Please contact Marianne Lynch, a technology development specialist, at 301-594-4094 or [e-mail] for more information.

Dated: July 17, 2007.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.