Description of Invention: The technology offered for licensing is foundational in the area of recombinant DNA vaccines. In the last several years, facilitated through a licensing program of the NIH, the technology has been broadly applied in the development and commercialization of several novel human and veterinary vaccines in the areas of infectious disease as well as cancer therapeutics. The NIH wishes to expand its licensing program of the subject technology in a variety of applications that will benefit public health.
Briefly, the technology describes and claims methods of constructing recombinant vaccines utilizing any recombinant poxvirus, and in particular vaccinia virus (i.e. Modified Vaccinia Ankara or other strains) as a backbone that carries a foreign DNA. The foreign DNA can be related to a viral pathogen for example, or to a tumor-associated antigen. Upon administration of the recombinant virus to a human or animal subject, the foreign gene is expressed in vivo to elicit an immune response against the respective pathogen or the respective tumor.
The technology takes advantage of the unique properties of poxviruses as a delivering vehicle and of the ease of preparation of such constructs.
The applications of this technology have been extensively covered by many publications, including more than 100 publications from the inventor (see sampling below). The publications cover a wide variety of vaccines such as HIV, papilloma virus, influenza and others.
Note: Samples of plasmids and vaccinia virus used in the invention are deposited in the American Type Culture Collection and in the NIH and may be available for licensees upon request.
Prophylactic and/or therapeutic vaccines
Infectious disease and cancer Human and animal vaccines
Protein expression system
Advantages: Recombinant Poxviruses vectors in DNA vaccines have exhibited some advantages as compared to other viral vectors such as adenovirus, retrovirus or papillomavirus:
High safety profile
Wide host range
Ability to accommodate large amounts of foreign DNA including multiple genes
No loss of infectivity upon insertion of foreign DNA
Unique transcriptional regulatory signals of the virus facilitates flexibility in genome strategy
In addition, the following properties have been demonstrated:
Immunization with vaccinia-vectored vaccines provides long-lasting protection
Vaccinia virus is very stable and no cold-chain is required in distribution network
Induce mucosal immune response
Induce humeral and cellular immunity
Development Status: Fully developed. The technology has been already successfully implemented in commercial veterinary vaccines (i.e. rabies) and is in advance clinical trials in several companies in the area of cancer immunotherapy.
Patent Status: HHS, Reference No. E-552-1982/2 US, , Patent No. 6,998,252, Issued 14 Feb 2006 US, , Patent No. 7,015,024, Issued 21 Mar 2006 US, , Patent No. 7,045,136, Issued 16 May 2006 US, , Patent No. 7,045,313, Issued 16 May 2006 PCT, Application No. PCT/US83/01863 filed 28 Nov 1983
B Moss and PL Earl. Overview of the vaccinia virus expression system. Curr Protoc Mol Biol. 2002 Nov; Chapter 16:Unit16.15. [ PubMed abs ]
HL Robinson, S Sharma, J Zhao, S Kannanganat, L Lai, L Chennareddi, T Yu, DC Montefiori, RR Amara, LS Wyatt, B Moss. Immunogenicity in macaques of the clinical product for a clade B DNA/MVA HIV vaccine: elicitation of IFN-gamma, IL-2, and TNF-alpha coproducing CD4 and CD8 T cells. AIDS Res Hum Retroviruses. 2007 Dec;23(12):1555-1562. [ PubMed abs ]
LS Wyatt, PL Earl, J Vogt, LA Eller, D Chandran, J Liu, HL Robinson, B Moss. Correlation of immunogenicities and in vitro expression levels of recombinant modified vaccinia virus Ankara HIV vaccines. Vaccine 2008 Jan 24;26(4):486-493. [ PubMed abs ]
M Hebben, J Brants, C Birck, JP Samama, B Wasylyk, D Spehner, K Pradeau, A Domi, B Moss, P Schultz, R Drillien. High level protein expression in mammalian cells using a safe viral vector: modified vaccinia virus Ankara. Protein Expr Purif. 2007 Dec;56(2):269-278. [ PubMed abs ]
Licensing Status: Available for licensing.
Portfolios: Infectious Diseases - Vaccines In-vivo Data In-vitro Data
For Additional Information Please Contact: Susan Ano Ph.D. NIH Office of Technology Transfer 6011 Executive Blvd. Suite 325, Rockville, MD 20852 United States Email: email@example.com Phone: 301-435-5515 Fax: 301-402-0220