E7-11195. 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.

A Sensitive, High Throughput Pseudovirus-Based Papillomavirus Neutralization Assay for HPV 16 and HPV 18

Description of Technology: This invention is a research tool for measuring protective antibody responses against Human Papilloma Viruses (HPV). Sensitive high-throughput neutralization assays, based upon pseudoviruses carrying a secreted alkaline phosphatase (SEAP) reporter gene, were developed and validated by the inventors for HPV 16, HPV 18, and bovine papillomavirus 1 (BPV1). In a 96-well plate format, the assay was reproducible and appears to be as sensitive as, but more type-specific than, a standard papillomavirus-like particle (VLP)-based enzyme-linked immunosorbent assay (ELISA). The SEAP pseudovirus-based neutralization assay should be a practical method for quantifying potentially protective antibody responses in HPV natural history and prophylactic vaccine studies.

Inventors: John T. Schiller (NCI), Douglas R. Lowy (NCI), Christopher Buck (NCI), Diana V. Pastrana (NCI), et al.

Publication: The assay is further described in Pastrana et al., “Reactivity of human sera in a sensitive, high-throughput pseudovirus-based papillomavirus neutralization assay for HPV16 and HPV18,” Virology. 2004 Apr 10;321(2):205-216.

Patent Status: HHS Reference No. E-137-2004/0—Research Material.

Licensing Status: This assay is available nonexclusively through a biological materials license.

Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; soukasp @mail.nih.gov.

Development of a Novel High Throughput Assay To Measure Cell-Infection With Vaccinia Strains Expressing Reporter Genes

Description of Technology: Critical to developing a vaccine against viral infections is an assay to measure the neutralizing antibody present in blood of vaccine recipients. The currently available tests are labor intensive and require 5-6 days to complete. The inventors have designed a high throughput vaccinia neutralization assay, which offers several advantages over the assays that are currently used. It is completed in as little as 24 hours, it is sensitive, highly reproducible, requires only 50 μl of plasma and uses automated readout. This assay is based on the use of recombinant vaccinia virus (vSC56) expressing a bacterial gene coding for the enzyme b-galactosidase (b-Gal) under the control of a synthetic early/late promotor. Another recombinant virus expressing an inducible reporter gene (Luciferase) is also being tested in neutralization assay. These assays may be of value in the clinical trials of new smallpox vaccines, for evaluations of new vaccinia immunoglobulin (VIG) and anti-viral agents under development. The technology itself may be adapted for construction of neutralization assays for other viruses and intracellular pathogens.

Inventor: Hana Golding (FDA).

Publications:

1. J Manischewitz et al. Development of a novel vaccinia-neutralization assay based on reporter-gene expression. J Infect Dis. 2003 Aug 1;188(3):440-448.

2. Y Edghill-Smith et al. Modeling a safer smallpox vaccination regimen, for human immunodeficiency virus type 1-infected patients, in immunocompromised macques. J Infect Dis. 2003 Oct 15;188(8):1181-1191.

3. JC Goldsmith et al. Intravenous immunoglobulin products contain neutralizing antibodies to vaccinia. Vox Sang. 2004 Feb;86(2):125-129.

4. Y Edghill-Smith et al. Smallpox vaccine does not protect macaques with AIDS from a lethal monkeypox virus challenge. J Infect Dis. 2005 Feb 1;191(3):372-381.

5. Y Edghill-Smith et al. Smallpox vaccine-induced antibodies are necessary and sufficient for protection against monkeypox virus. Nat Med. 2005 Jul;11(7):740-747.

6. CA Meseda et al. Enhanced immunogenicity and protective effect conferred by vaccination with combinations of modified vaccinia Ankara and licensed smallpox vaccine Dryvax in a mouse model. Virology. 2005 Sep 1;339(2):164-175.

7. KH Waibel et al. Clinical and immunological comparison of smallpox vaccination administered to the outer versus the inner upper arms of vaccinia-naïve adults. Clin Infect Dis. 2006 Feb 15;42(4):e16-20.

8. JM Heraud et al. Subunit recombinant vaccine protects against monkeypox . J.Immunol. 2006 Aug 15;177(4):2552-2564.

9. VL Kan et al. Durable neutralizing antibodies after remote smallpox vaccination among adults with and without HIV infection. AIDS. 2007 Feb 19;21(4):521-524.

Patent Status: U.S. Provisional Patent Application 60/429,767 filed 27 Nov 2002 (HHS Reference No. E-300-2002/0-US-01); PCT Application No. PCT/US03/37677 filed 24 Nov 2003, which published as WO 2004/053454 on 24 Jun 2004 (HHS Reference No. E-300-2002/0-PCT-02); U.S. Patent Application No. 10/536,860 filed 06 Jan 2006 (HHS Reference No. E-300-2002/0-US-05).

Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; soukasp @mail.nih.gov.

Collaborative Research Opportunity: The CBER/FDA Laboratory of Retrovirus Research is seeking statements of capability or interest from parties interested in collaborative research to further develop or evaluate novel anti-vaccinia agents including monoclonal antibodies and vaccines. Please contact Hana Golding at Tel: [phone] or E-mail: [e-mail] for more information.

Vectors for Delivering Viral and Oncogenic Inhibitors

Description of Technology: The invention concerns cell transduction vectors which are capable of inhibiting viral replication in cells transduced with these vectors, and which also are capable of inhibiting the growth of cancer cells. Specifically, these expressions vectors produce protective genes which interfere with viral replication. These genes are tightly regulated by HIV-1 Tat and Rev proteins, which if produced after infection can induce expression of the protective genes. The vectors contain either a single gene (delta-gag), or a combination of two different genes (delta-gag and RNAse) which interfere with HIV-1 replication at different stages of the HIV-1 life cycle. Following transduction of target cells, the mRNA for the protective genes is incorporated into the newly budding virion along with the viral genomic mRNA. Following infection of neighboring cells, the mRNA for the protective gene can be reverse transcribed and integrated into these cells, thereby increasing the proportion of cells containing the protective gene.

In providing protection against viral replication, the vectors embodied in this invention could be used in gene therapy against HIV and against other viral diseases. In addition, the vectors could be used for introducing specific genes into neoplastic cells and thereby be effective in treating cancer and other diseases.

Inventors: Susanna M. Rybak, Andrea Cara, Gabriella L. Gusella, Dianne L. Newton (NCI).

Patent Status: U.S. Patent No. 6,953,687 issued 11 Oct 2005 (HHS Reference No. E-117-1996/0-US-07); U.S. Patent Application No. 11/043,858 filed 24 Jan 2005 (HHS Reference No. E-117-1996/0-US-08).

Licensing Status: Available for exclusive or non-exclusive licensing.

Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; soukasp @mail.nih.gov.

Dated: June 4, 2007.

Steven M. Ferguson,

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