Government-Owned Inventions; Availability for Licensing, 9399-9401 [2013-02834]

Download as PDF Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Notices sroberts on DSK5SPTVN1PROD with NOTICES GHB is classified as a central nervous system depressant. In 2002, FDA approved a GHB-containing product, Xyrem, for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy under the regulations in 21 CFR part 314, subpart H (21 CFR 314.520). Xyrem was included on the list of products deemed to have in effect an approved Risk Evaluation and Mitigation Strategy (REMS) under section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) at the time of the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The REMS for Xyrem includes a medication guide and healthcare provider education brochure, mandatory patient and prescriber certification through enrollment, and restricted dispensing of the drug through a central pharmacy. Xyrem is controlled domestically in Schedule III of the CSA, while bulk GHB and all other material containing GHB are controlled in Schedule I. In addition, illicit use of Xyrem is subject to Schedule I penalties of the CSA. GHB is controlled internationally in Schedule IV of the Psychotropic Convention. The WHO ECDD pre-reviewed GHB at its Thirty-fourth meeting and recommended it for critical review at a future meeting. The WHO ECDD met in Hammamet, Tunisia, from 4–8 June 2012, critically reviewed GHB, and recommended that it be rescheduled from Schedule IV to Schedule II of the Convention on Psychotropic Substances. IV. Submission of Comments and Opportunity for Public Meeting Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. FDA does not presently plan to hold a public meeting. If any person believes that, in addition to their written comments, a public meeting would contribute to the development of the U.S. position on the substances to be considered for control under the Psychotropic Convention, a request for a public meeting and the reasons for such a request should be sent to James R. Hunter (see FOR FURTHER INFORMATION VerDate Mar<15>2010 17:23 Feb 07, 2013 Jkt 229001 CONTACT) on or before February 19, 2013. The short time period for the submission of comments and requests for a public meeting is needed to ensure that HHS may, in a timely fashion, carry out the required action and be responsive to the United Nations. Dated: February 1, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–02859 Filed 2–7–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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. FOR FURTHER INFORMATION CONTACT: 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. SUMMARY: Therapeutic Hepatitis C Virus Antibodies Description of Technology: Therapeutic antibodies against Hepatitis C Virus (HCV) have not been very effective in the past and there is evidence that this may result in part from interfering antibodies generated during infection that block the action of neutralizing antibodies. These neutralizing antibodies prevent HCV infection of a host cell. The subject technologies are monoclonal antibodies against HCV that can neutralize different genotypes of HCV. Both antibodies bind to the PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 9399 envelope (E2) protein of HCV found on the surface of the virus. One of the monoclonal antibodies neutralizes HCV genotype 1a, the most prevalent HCV strain in the U.S., infection and in vitro data show that it is not blocked by interfering antibodies. The second antibody binds a conserved region of E2 and can cross neutralize a number of genotypes including genotypes 1a and 2a. The monoclonal antibodies have the potential to be developed either alone or in combination into therapeutic antibodies that prevent or treat HCV infection. These antibodies may be particularly suited for preventing HCV re-infection in HCV patients who undergo liver transplants; a population of patients that is especially vulnerable to the side effects of current treatments for HCV infection. Potential Commercial Applications: Therapeutic antibodies for the prevention and/or treatment of HCV infection. Competitive Advantages • Therapeutic antibodies have generally fewer side effects than current treatments for HCV infection. • Potential to be developed into an alternative treatment for HCV infected liver transplant patients, who often cannot tolerate the side effects of current drug treatments. Development Stage • Early-stage • Pre-clinical • In vitro data available Inventors: Stephen M. Feinstone, Hongying Duan, Pei Zhang, Marian E. Major, Alla V. Kachko (all of FDA) Publications 1. Kachko A, et al. New neutralizing antibody epitopes in hepatitis C virus envelope glycoproteins are revealed by dissecting peptide recognition profiles. Vaccine. 2011 Dec 9;30(1):69–77. [PMID 22041300] 2. Duan H, et al. Amino acid residuespecific neutralization and nonneutralization of hepatitis C virus by monoclonal antibodies to the E2 protein. J Virol. 2012 Dec;86(23):12686–94. [PMID 22973024] Intellectual Property • HHS Reference No. E–002–2012/ 0—U.S. Provisional Patent Application No. 61/648,386 filed 17 May 2012 • HHS Reference No. E–167–2012/ 0—International PCT Application No. PCT/US12/62197 filed 26 Oct 2012 Licensing Contact: Kevin W. Chang, Ph.D.; 301–435–5018; changke@mail.nih.gov E:\FR\FM\08FEN1.SGM 08FEN1 9400 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Notices Live Attenuated Rubella Vector to Express Vaccine Antigens Description of Technology: Live attenuated viruses make potent and effective vaccines. Despite the urgent need for an HIV vaccine, this approach has not been feasible because it has not been possible to attenuate the virus reliably and guarantee vaccine safety. Instead, live viral vectors have been proposed that could present HIV vaccine antigens in the most immunogenic way, in the context of an active infection. The inventors have adapted a rubella vaccine strain as a vector to express HIV and SIV antigen and tested the effect of insert size and composition on vector stability and viral titer. The inventors have identified an acceptor site in the rubella nonstructural gene region, where foreign genes can be expressed as a fusion protein with the nonstructural protein P150 without affecting essential viral functions. The inserts were expressed as early genes of rubella, under control of the rubella genomic promoter. At this site, HIV and SIV antigens were expressed stably for at least seven passages, as the rubella vectors reached high titers. Rubella readily infects rhesus macaques, and these animals will provide an ideal model for testing the new vectors for replication in vivo, immunogenicity and protection against SIV or SHIV challenge. Potential Commercial Applications • HIV vaccines • Bivalent rubella • Research tools Competitive Advantages • Ease of manufacture • Low cost vaccines Development Stage • Pre-clinical • In vitro data available • In vivo data available (animal) Inventors: Ira Berkower and Konstantin Virnik (FDA/CBER) Publication sroberts on DSK5SPTVN1PROD with NOTICES Virnik K, et al. Live attenuated rubella viral vectors stably express HIV and SIV vaccine antigens while reaching high titers. Vaccine. 2012 Aug 10;30(37):5453–8. [PMID 22776214] Intellectual Property • HHS Reference No. E–004–2012/ 0—US Application No. 61/621,394, filed 6 Apr 2012 • HHS Reference No. E–004–2012/ 1—US Application No. 61//642,333 filed 3 May 2012 VerDate Mar<15>2010 17:23 Feb 07, 2013 Jkt 229001 Related Technologies • HHS Reference No. E–156–2008/ 0—US Application No. 13/501,893 filed 13 Apr 2012, claiming priority to 16 Oct 2009 • HHS Reference No. E–291–2008/ 0—US Application No. 13/057,414 filed 03 Feb 2011, claiming priority to 04 Aug 2008 • HHS Reference No. E–299–2008/ 0—US Application No. 12/714,085 filed 26 Feb 2010, claiming priority to 26 Feb 2009 Licensing Contact: Peter A. Soukas; 301–435–4646; soukasp@mail.nih.gov DNA Promoters and Anthrax Vaccines 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 B. anthracis protective antigen (PA) gene for optimal expression and stability, linked it to an inducible promoter for maximal expression in the host, and fused to the secretion signal of the Escherichia coli alpha-hemolysin protein (HlyA) on a low-copy-number plasmid. This plasmid was introduced into the licensed typhoid vaccine strain, Salmonella enterica serovar Typhi strain Ty21a, and was found to be genetically stable. Immunization of mice with three vaccine doses elicited a strong PA-specific serum immunoglobulin G response with a geometric mean titer of 30,000 (range, 5,800 to 157,000) and lethal-toxinneutralizing titers greater than 16,000. Vaccinated mice demonstrated 100% protection against a lethal intranasal challenge with aerosolized spores of B. anthracis 7702. Potential Commercial Applications: Anthrax vaccines, therapeutics and diagnostics. 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— • EP Application No. 04809769.5 filed 20 Sep 2004 • US Patent No. 7,758,855 issued 20 Jul 2010 • US Patent No. 8,247,225 issued 21 Aug 2012 • US Application No. 13/551,168 filed 17 Jul 2012 Licensing Contact: Peter A. Soukas; 301–435–4646; soukasp@mail.nih.gov Collaborative Research Opportunity: The FDA Center for Biologics Evaluation and Research is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize oral anthrax vaccine. For collaboration opportunities, please contact Dr. Dennis J. Kopecko at dennis.kopecko@fda.hhs.gov or 301– 661–8839. 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. Live Oral Shigella Dysenteriae Vaccine Description of Technology: This application claims a Salmonella typhi Ty21a construct comprising a Shigella dysenteriae O-specific polysaccharide (O-Ps) inserted into the Salmonella typhi Ty21a chromosome, where heterologous Shigella dysenteriae serotype 1 O-antigen is stably expressed together with homologous Salmonella typhi O-antigen. The constructs of this invention elicit immune protection against virulent Shigella dysenteriae challenge, as well as Salmonella typhi challenge. Also claimed in this application are methods of making the constructs of this invention and methods for inducing an immune response. Shigella cause millions of cases of dysentery every year, which result in about seven hundred thousand deaths worldwide. Shigella dysenteriae serotype 1, one of about forty serotypes of Shigella, causes a more severe disease with a much higher mortality rate than other serotypes. There are no licensed vaccines available for protection against Shigella. The fact that many isolates exhibit multiple antibiotic resistance complicates the management of dysentery infections. Development Stage • Pre-clinical • In vitro data available • In vivo data available (animal) Potential Commercial Applications • One component of a multivalent anti-shigellosis vaccine under development. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\08FEN1.SGM 08FEN1 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Notices • 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 • Pre-clinical • 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 Oantigen 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— • EP Application No. 05754091.6 filed 24 May 2005 • EP Application No. 12186545.5 filed 24 May 2005 • US Patent No. 8,071,113 issued 06 Dec 2011 • US Patent No. 8,337,831 issued 25 Dec 2012 • US Application No. 13/687,797 filed 28 Nov 2012 Licensing Contact: Peter A. Soukas; 301–435–4646; soukasp@mail.nih.gov Collaborative Research Opportunity: The FDA Center for Biologics Evaluation and Research is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize combination typhoidshigellosis oral vaccine. For collaboration opportunities, please contact Dr. Dennis J. Kopecko at dennis.kopecko@fda.hhs.gov or 301– 661–8839. sroberts on DSK5SPTVN1PROD with NOTICES Oral Shigellosis Vaccine Description of Technology: This application claims a Salmonella typhi Ty21a construct comprising a Shigella sonnei O-antigen biosynthetic gene region inserted into the Salmonella typhi Ty21a chromosome, where heterologous Shigella sonnei form 1 Oantigen is stably expressed together with homologous Salmonella typhi Oantigen. The constructs of this invention elicit immune protection against virulent Shigella sonnei challenge, as well as Salmonella Typhi challenge. VerDate Mar<15>2010 17:23 Feb 07, 2013 Jkt 229001 Also claimed in this application are methods of recombineering a large antigenic gene region into a bacterial chromosome. Bacillary dysentery and enteric fevers continue to be important causes of morbidity in both developed and developing nations. Shigella cause greater than one hundred and fifty million cases of dysentery and enteric fever occurs in greater than twentyseven million people annually. Currently, there is no licensed vaccine to prevent the occurrence of shigellosis. Increasing multiple resistance in Shigella commonly thwarts local therapies. 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 • Pre-clinical • 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 (accepted). Intellectual Property: HHS Reference No. E–168–2012/0—US Application No. 61/701,939 filed 17 Sep 2012 Licensing Contact: Peter A. Soukas; 301–435–4646; soukasp@mail.nih.gov Collaborative Research Opportunity: The FDA Center for Biologics Evaluation and Research is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize oral Shigellosis vaccine. For collaboration opportunities, please contact Dr. Dennis J. Kopecko at dennis.kopecko@fda.hhs.gov or 301– 661–8839. Dated: February 1, 2013. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–02834 Filed 2–7–13; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 9401 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Beta-Cell Function and Cognition. Date: March 4, 2013. Time: 3:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Barbara A. Woynarowska, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 754, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 402–7172, woynarowskab@niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; NIDDK R24 SEP. Date: March 4, 2013. Time: 12:30 p.m. to 1:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Health, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Xiaodu Guo, MD, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 761, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–4719, guox@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Liver Related Ancillary Studies. Date: March 13, 2013 Time: 1:30 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Paul A. Rushing, Ph.D., Scientific Review Officer, Review Branch, E:\FR\FM\08FEN1.SGM 08FEN1

Agencies

[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Notices]
[Pages 9399-9401]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02834]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

FOR FURTHER INFORMATION CONTACT: 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.

Therapeutic Hepatitis C Virus Antibodies

    Description of Technology: Therapeutic antibodies against Hepatitis 
C Virus (HCV) have not been very effective in the past and there is 
evidence that this may result in part from interfering antibodies 
generated during infection that block the action of neutralizing 
antibodies. These neutralizing antibodies prevent HCV infection of a 
host cell.
    The subject technologies are monoclonal antibodies against HCV that 
can neutralize different genotypes of HCV. Both antibodies bind to the 
envelope (E2) protein of HCV found on the surface of the virus. One of 
the monoclonal antibodies neutralizes HCV genotype 1a, the most 
prevalent HCV strain in the U.S., infection and in vitro data show that 
it is not blocked by interfering antibodies. The second antibody binds 
a conserved region of E2 and can cross neutralize a number of genotypes 
including genotypes 1a and 2a. The monoclonal antibodies have the 
potential to be developed either alone or in combination into 
therapeutic antibodies that prevent or treat HCV infection. These 
antibodies may be particularly suited for preventing HCV re-infection 
in HCV patients who undergo liver transplants; a population of patients 
that is especially vulnerable to the side effects of current treatments 
for HCV infection.
    Potential Commercial Applications: Therapeutic antibodies for the 
prevention and/or treatment of HCV infection.

Competitive Advantages

     Therapeutic antibodies have generally fewer side effects 
than current treatments for HCV infection.
     Potential to be developed into an alternative treatment 
for HCV infected liver transplant patients, who often cannot tolerate 
the side effects of current drug treatments.

Development Stage

     Early-stage
     Pre-clinical
     In vitro data available
    Inventors: Stephen M. Feinstone, Hongying Duan, Pei Zhang, Marian 
E. Major, Alla V. Kachko (all of FDA)

Publications

    1. Kachko A, et al. New neutralizing antibody epitopes in 
hepatitis C virus envelope glycoproteins are revealed by dissecting 
peptide recognition profiles. Vaccine. 2011 Dec 9;30(1):69-77. [PMID 
22041300]
    2. Duan H, et al. Amino acid residue-specific neutralization and 
nonneutralization of hepatitis C virus by monoclonal antibodies to 
the E2 protein. J Virol. 2012 Dec;86(23):12686-94. [PMID 22973024]

Intellectual Property

     HHS Reference No. E-002-2012/0--U.S. Provisional Patent 
Application No. 61/648,386 filed 17 May 2012
     HHS Reference No. E-167-2012/0--International PCT 
Application No. PCT/US12/62197 filed 26 Oct 2012
    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
changke@mail.nih.gov

[[Page 9400]]

Live Attenuated Rubella Vector to Express Vaccine Antigens

    Description of Technology: Live attenuated viruses make potent and 
effective vaccines. Despite the urgent need for an HIV vaccine, this 
approach has not been feasible because it has not been possible to 
attenuate the virus reliably and guarantee vaccine safety. Instead, 
live viral vectors have been proposed that could present HIV vaccine 
antigens in the most immunogenic way, in the context of an active 
infection.
    The inventors have adapted a rubella vaccine strain as a vector to 
express HIV and SIV antigen and tested the effect of insert size and 
composition on vector stability and viral titer. The inventors have 
identified an acceptor site in the rubella nonstructural gene region, 
where foreign genes can be expressed as a fusion protein with the 
nonstructural protein P150 without affecting essential viral functions. 
The inserts were expressed as early genes of rubella, under control of 
the rubella genomic promoter. At this site, HIV and SIV antigens were 
expressed stably for at least seven passages, as the rubella vectors 
reached high titers. Rubella readily infects rhesus macaques, and these 
animals will provide an ideal model for testing the new vectors for 
replication in vivo, immunogenicity and protection against SIV or SHIV 
challenge.

Potential Commercial Applications

     HIV vaccines
     Bivalent rubella
     Research tools

Competitive Advantages

     Ease of manufacture
     Low cost vaccines

Development Stage

     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Ira Berkower and Konstantin Virnik (FDA/CBER)

Publication

Virnik K, et al. Live attenuated rubella viral vectors stably 
express HIV and SIV vaccine antigens while reaching high titers. 
Vaccine. 2012 Aug 10;30(37):5453-8. [PMID 22776214]

Intellectual Property

     HHS Reference No. E-004-2012/0--US Application No. 61/
621,394, filed 6 Apr 2012
     HHS Reference No. E-004-2012/1--US Application No. 61//
642,333 filed 3 May 2012

Related Technologies

     HHS Reference No. E-156-2008/0--US Application No. 13/
501,893 filed 13 Apr 2012, claiming priority to 16 Oct 2009
     HHS Reference No. E-291-2008/0--US Application No. 13/
057,414 filed 03 Feb 2011, claiming priority to 04 Aug 2008
     HHS Reference No. E-299-2008/0--US Application No. 12/
714,085 filed 26 Feb 2010, claiming priority to 26 Feb 2009
    Licensing Contact: Peter A. Soukas; 301-435-4646; 
soukasp@mail.nih.gov

DNA Promoters and Anthrax Vaccines

    Description of Technology: Currently, the only licensed vaccine 
against anthrax in the United States is AVA BioThrax[supreg], 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 B. anthracis protective antigen 
(PA) gene for optimal expression and stability, linked it to an 
inducible promoter for maximal expression in the host, and fused to the 
secretion signal of the Escherichia coli alpha-hemolysin protein (HlyA) 
on a low-copy-number plasmid. This plasmid was introduced into the 
licensed typhoid vaccine strain, Salmonella enterica serovar Typhi 
strain Ty21a, and was found to be genetically stable. Immunization of 
mice with three vaccine doses elicited a strong PA-specific serum 
immunoglobulin G response with a geometric mean titer of 30,000 (range, 
5,800 to 157,000) and lethal-toxin-neutralizing titers greater than 
16,000. Vaccinated mice demonstrated 100% protection against a lethal 
intranasal challenge with aerosolized spores of B. anthracis 7702.
    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

     Pre-clinical
     In vitro data available
     In vivo data available (animal)

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--
     EP Application No. 04809769.5 filed 20 Sep 2004
     US Patent No. 7,758,855 issued 20 Jul 2010
     US Patent No. 8,247,225 issued 21 Aug 2012
     US Application No. 13/551,168 filed 17 Jul 2012
    Licensing Contact: Peter A. Soukas; 301-435-4646; 
soukasp@mail.nih.gov
    Collaborative Research Opportunity: The FDA Center for Biologics 
Evaluation and Research is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate or commercialize oral anthrax vaccine. For collaboration 
opportunities, please contact Dr. Dennis J. Kopecko at 
dennis.kopecko@fda.hhs.gov or 301-661-8839.

Live Oral Shigella Dysenteriae Vaccine

    Description of Technology: This application claims a Salmonella 
typhi Ty21a construct comprising a Shigella dysenteriae O-specific 
polysaccharide (O-Ps) inserted into the Salmonella typhi Ty21a 
chromosome, where heterologous Shigella dysenteriae serotype 1 O-
antigen is stably expressed together with homologous Salmonella typhi 
O-antigen. The constructs of this invention elicit immune protection 
against virulent Shigella dysenteriae challenge, as well as Salmonella 
typhi challenge. Also claimed in this application are methods of making 
the constructs of this invention and methods for inducing an immune 
response.
    Shigella cause millions of cases of dysentery every year, which 
result in about seven hundred thousand deaths worldwide. Shigella 
dysenteriae serotype 1, one of about forty serotypes of Shigella, 
causes a more severe disease with a much higher mortality rate than 
other serotypes. There are no licensed vaccines available for 
protection against Shigella. The fact that many isolates exhibit 
multiple antibiotic resistance complicates the management of dysentery 
infections.

Potential Commercial Applications

     One component of a multivalent anti-shigellosis vaccine 
under development.

[[Page 9401]]

     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

     Pre-clinical
     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--
     EP Application No. 05754091.6 filed 24 May 2005
     EP Application No. 12186545.5 filed 24 May 2005
     US Patent No. 8,071,113 issued 06 Dec 2011
     US Patent No. 8,337,831 issued 25 Dec 2012
     US Application No. 13/687,797 filed 28 Nov 2012
    Licensing Contact: Peter A. Soukas; 301-435-4646; 
soukasp@mail.nih.gov
    Collaborative Research Opportunity: The FDA Center for Biologics 
Evaluation and Research is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate or commercialize combination typhoid-shigellosis oral vaccine. 
For collaboration opportunities, please contact Dr. Dennis J. Kopecko 
at dennis.kopecko@fda.hhs.gov or 301-661-8839.

Oral Shigellosis Vaccine

    Description of Technology: This application claims a Salmonella 
typhi Ty21a construct comprising a Shigella sonnei O-antigen 
biosynthetic gene region inserted into the Salmonella typhi Ty21a 
chromosome, where heterologous Shigella sonnei form 1 O-antigen is 
stably expressed together with homologous Salmonella typhi O-antigen. 
The constructs of this invention elicit immune protection against 
virulent Shigella sonnei challenge, as well as Salmonella Typhi 
challenge. Also claimed in this application are methods of 
recombineering a large antigenic gene region into a bacterial 
chromosome.
    Bacillary dysentery and enteric fevers continue to be important 
causes of morbidity in both developed and developing nations. Shigella 
cause greater than one hundred and fifty million cases of dysentery and 
enteric fever occurs in greater than twenty-seven million people 
annually. Currently, there is no licensed vaccine to prevent the 
occurrence of shigellosis. Increasing multiple resistance in Shigella 
commonly thwarts local therapies.

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

     Pre-clinical
     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 
(accepted).

    Intellectual Property: HHS Reference No. E-168-2012/0--US 
Application No. 61/701,939 filed 17 Sep 2012
    Licensing Contact: Peter A. Soukas; 301-435-4646; 
soukasp@mail.nih.gov
    Collaborative Research Opportunity: The FDA Center for Biologics 
Evaluation and Research is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate or commercialize oral Shigellosis vaccine. For collaboration 
opportunities, please contact Dr. Dennis J. Kopecko at 
dennis.kopecko@fda.hhs.gov or 301-661-8839.

    Dated: February 1, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-02834 Filed 2-7-13; 8:45 am]
BILLING CODE 4140-01-P