National Institutes of Health, HHS.
Notice.
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. 209 and 37 CFR part 404 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.
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.
Technology descriptions follow.
Description of Technology: Shigellosis is a global human health problem. Transmission usually occurs by contaminated food and water or through person-to-person contact. The bacterium is highly infectious by the oral route, and ingestion of as few as 10 organisms can cause an infection in volunteers. An estimated 200 million people worldwide suffer from shigellosis, with more than 650,000 associated deaths annually. A recent CDC estimate indicates the occurrence of over 440,000 annual shigellosis cases in the United States alone, approximately eighty percent (80%) of which are caused by
Potential Commercial Applications:
• Shigella/Typhoid vaccine for travelers, military
• Shigella/Typhoid vaccine for developing countries
• Shigella/Typhoid diagnostics
Competitive Advantages:
• Low cost of production
• Temperature stable formulation
• Safety/efficacy of Ty21a established in humans
Development Stage: In vivo data available (animal)
Inventors: Dennis J. Kopecko (FDA), De Qi Xu (NIDCR), John O. Cisar (NICHD)
Publication: Kopecko DJ, et al. Molecular cloning and characterization of genes for Shigella sonnei form I O polysaccharide: proposed biosynthetic pathway and stable expression in a live salmonella vaccine vector. Infect Immun. 2002 Aug;70(8):4414–23. [PMID: 12117952]
Intellectual Property: HHS Reference No. E–210–2001/0 –
• US Patent No. 7,541,043 issued 02 Jun 2009
• US Patent No. 8,071,084 issued 06 Dec 2011
• US Patent No. 8,337,832 issued 25 Dec 2012
• US Patent Application No. 13/686,299 filed 27 Nov 2012
Licensing Contact: Peter A. Soukas; 301–435–4646;
Description of Technology: This application claims a
Potential Commercial Applications:
• One component of a multivalent anti-shigellosis vaccine under development.
• Shigella vaccines, therapeutics and diagnostics.
Competitive Advantages:
• Vector is well-characterized.
• Simple manufacturing process.
• Potential low-cost vaccine.
• Oral vaccine—avoids need for needles.
• Temperature-stable formulation allows for vaccine distribution without refrigeration.
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventors: Dennis J. Kopecko and De Qi Xu (FDA/CBER)
Publication: Xu DQ, et al. Core-linked LPS expression of Shigella dysenteriae serotype 1 O-antigen in live Salmonella typhi vaccine vector Ty21a: Preclinical evidence of immunogenicity and protection. Vaccine. 2007 Aug 14;25(33):6167–75. [PMID 17629369]
Intellectual Property: HHS Reference No. E–214–2004/0 -
• US Patent No. 8,071,113 issued 06 Dec 2011
• US Patent No. 8,337,831 issued 25 Dec 2012
• US Patent No. 8,790,635 issued 29 Jul 2014
• US Patent Application No. 14/145,104 filed 31 Dec 2013 (allowed)
• Various international patent applications pending
Licensing Contact: Peter A. Soukas; 301–435–4646;
Description of Technology: This application claims a
Bacillary dysentery and enteric fevers continue to be important causes of morbidity in both developed and developing nations.
Potential Commercial Applications:
• One component of a multivalent Shigellosis vaccine under development
• Research tool
Competitive Advantages:
• Low cost production
• Lower cost vaccine
• Oral vaccine—no needles required
• Temperature-stable manufacturing process—avoids need for refrigeration during vaccine distribution
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventors: Dennis J. Kopecko and Madushini N. Dharmasena (FDA/CBER)
Publication: Dharmasena MN, et al. Stable expression of Shigella sonnei form I O-polysaccharide genes recombineered into the chromosome of live Salmonella oral vaccine vector Ty21a. Int J Med Microbiol. 2013 Apr;303(3):105–13. [PMID 23474241]
Intellectual Property: HHS Reference No. E–168–2012/0 -
• US Provisional Application No. 61/701,939 filed 17 Sep 2012
• PCT Application No. PCT/US2013/059980 filed 16 Sep 2013, which published as WO 2014/043637 on 20 Mar 2014
Licensing Contact: Peter A. Soukas; 301–435–4646;
Description of Technology: Ty21a, the licensed oral live, attenuated bacterial vaccine for
This application claims an engineered Ty21a vector that can survive a very low pH for two to three hours (
Potential Commercial Applications:
• Shigella vaccines
• Biodefense vaccines
• Diagnostics
Competitive Advantages:
• Ease of manufacture
• Inexpensive to manufacture
• Ease of administration
• Known live attenuated bacterial vector
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventors: Madushini N. Dharmasena and Dennis J. Kopecko (FDA/CBER)
Intellectual Property: HHS Reference No. E–535–2013/0 -
• US Provisional Application No. 61/862,815 filed 06 Aug 2013
• PCT Application No. PCT/US2014/049933 filed 06 Aug 2014
Licensing Contact: Peter A. Soukas; 301–435–4646;
Description of Technology: This technology comprises live, attenuated
Potential Commercial Applications:
• Development of live attenuated bacterial cancer vaccines, cancer therapeutics and diagnostics.
• Developing/developed world vaccine.
Competitive Advantages:
• Low cost of production
• Vaccine vector safety/efficacy in humans established
Development Status: In vivo data available (animal)
Inventors: Dennis J. Kopecko (FDA), De Qi Xu (FDA), Ling Zhang (Jilin University), Xuejian Zhao (Jilin University), Jiadi Hu (University of Maryland)
Publications:
1. Zhang L, et al. Intratumoral delivery and suppression of prostate tumor growth by attenuated Salmonella enterica serovar typhimurium carrying plasmid-based small interfering RNAs. Cancer Res. 2007 Jun 15;67(12):5859–64. [PMID 17575154]
2. Zhang L, et al. Effects of plasmid-based Stat3-specific short hairpin RNA and GRIM–19 on PC–3M tumor cell growth. Clin Cancer Res. 2008 Jan 15;14(2):559–68. [PMID 18223232]
Intellectual Property: HHS Reference No. E–278–2007/0 -
• PCT Application No. PCT/US2007/074272 filed 27 Jul 2007, which published as WO 2008/091375 on 31 Jul 2008
• U.S. Patent Application No. 12/374,916 filed 23 Jan 2009
• International Application No. 200610017045.5 filed in China 27 Jul 2006
Licensing Contact: Peter A. Soukas; 301–435–4616;
Description of Technology: Currently, the only licensed vaccine against anthrax in the United States is AVA BioThrax®, which, although efficacious, suffers from several limitations. This vaccine requires six injectable doses over 18 months to stimulate protective immunity, requires a cold chain for storage, and in many cases has been associated with adverse effects.
This application claims a modified
Potential Commercial Applications: Anthrax vaccines, therapeutics and diagnostics.
Competitive Advantages:
• Vector is well-characterized.
• Simple manufacturing process.
• Potential low-cost vaccine.
• Oral vaccine—avoids needles and can be administered rapidly during emergencies.
• Temperature-stable manufacturing allows for vaccine distribution without refrigeration.
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventors: Dennis J. Kopecko, Siba Bhattacharyya, Milan Blake (all of FDA/CBER)
Publication: Osorio M, et al. Anthrax protective antigen delivered by Salmonella enterica serovar Typhi Ty21a protects mice from a lethal anthrax spore challenge. Infect Immun. 2009 Apr;77(4):1475–82. [PMID 19179420]
Intellectual Property: HHS Reference No. E–344–2003/1 -
• U.S. Patent No. 7,758,855 issued 20 Jul 2010
• U.S. Patent No. 8,247,225 issued 21 Aug 2012
• U.S. Patent No. 8,709,813 issued 29 Apr 2014
• U.S. Patent Application No. 14/185,353 filed 20 Feb 2014
• Various international patents issued
Licensing Contact: Peter A. Soukas; 301–435–4646;
Description of Technology:
This invention claims the generation and development of a candidate oral vaccine against plague. The vaccine consists of a synthetic gene construct that expresses a
Potential Commercial Applications: Plague vaccines, therapeutics and diagnostics.
Competitive Advantages:
• Vector is well-characterized.
• Simple manufacturing process.
• Potential low-cost vaccine.
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventors: Dennis J. Kopecko, Manuel A. Osorio, Monica R. Foote (all of FDA/CBER)
Intellectual Property: HHS Reference No. E–105–2011/0 -
• U.S. Provisional Application No. 61/650,676 filed 23 May 2012
• PCT Application No. PCT/US2013/042240 filed 22 May 2013, which published as WO 2013/177291 on 28 Nov 2013
Related Technologies: HHS Reference No. E–344–2003/1-
• U.S. Patent No. 7,758,855 issued 20 Jul 2010
• U.S. Patent No. 8,247,225 issued 21 Aug 2012
• U.S. Patent No. 8,709,813 issued 29 Apr 2014
• U.S. Patent Application No. 14/185,353 filed 20 Feb 2014
• Various international patents issued
Licensing Contact: Peter A. Soukas; 301–435–4616;