[Federal Register Volume 73, Number 206 (Thursday, October 23, 2008)]
[Notices]
[Pages 63166-63167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25220]


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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.

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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: 301-496-7057; fax: 301-402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Vaccine for Protection Against Shigella sonnei Disease

    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 Shigella 
sonnei. Shigella sonnei is more active in developed countries. Shigella 
infections are typically treated with a course of antibiotics. However, 
due to the emergence of multidrug resistant Shigella strains, a safe 
and effective vaccine is highly desirable. No vaccines against Shigella 
infection currently exist. Immunity to Shigellae is mediated largely by 
immune responses directed against the serotype specific O-
polysaccharide. Claimed in the invention are compositions and methods 
for inducing an immunoprotective response against S.

[[Page 63167]]

sonnei. Specifically, an attenuated bacteria capable of expressing an 
S. sonnei antigen comprised of the S. sonnei form I O-polysaccharide 
expressed from the S. sonnei rfb/rfc gene cluster is claimed. The 
inventors have shown that the claimed vaccine compositions showed one 
hundred percent (100%) protection against parenteral challenge with 
virulent S. sonnei in mice.
    Inventors: Dennis J. Kopecko (FDA), De-Qi Xu (NIDCR), John O. Cisar 
(NIDCR).
    Patent Status: U.S. Patent Application No. 10/346,706 filed 15 Jan 
2003, claiming priority to 16 Jan 2002 (HHS Reference No. E-210-2001/0-
US-02)
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected].

Methods for Preparing Complex Multivalent Immunogenic Conjugates

    Description of Technology: Claimed in this application are novel 
methods for preparing complex multivalent immunogenic conjugates and 
conjugate vaccines. The multivalent conjugates and conjugate vaccines 
are synthesized by conjugating mixtures of more than one polysaccharide 
at a desired ratio of the component polysaccharides to at least one 
carrier protein using hydrazide chemistry. Because of the high 
efficiency of hydrazide chemistry in conjugation, the polysaccharides 
are effectively conjugated to the carrier protein(s) so that the 
resulting complex synthesized vaccine conjugate products, without 
requiring tedious and complicated purification procedures such as 
chromatography and/or ammonium sulfate precipitation, are efficacious 
in inducing antibodies in mice against each component polysaccharide. 
The methods claimed in this application simplify the preparation of 
multivalent conjugate vaccines by utilizing simultaneous conjugation 
reactions in a single reaction mixture or batch that includes at least 
two immunogenic-distinct polysaccharides. This single-batch 
simultaneous reaction eliminates the need for multiple parallel 
synthesis processes for each polysaccharide vaccine conjugate component 
as employed in conventional methods for making multivalent conjugate 
vaccines.
    Application: Cost effective and efficient manufacturing of 
conjugate vaccines.
    Inventors: Che-Hung Robert Lee (CBER/FDA).
    Patent Status: PCT Application No. PCT/US2007/006627 filed 16 Mar 
2007, which published as WO 2007/109129 on 27 Sep 2007 (HHS Reference 
No. E-085-2005/0-PCT-02); U.S. Patent Application filed 15 Sep 2008 
(HHS Reference No. E-085-2005/0-US-03).
    Licensing Status: Available for exclusive or non-exclusive 
licensing. The technology is not available for licensing in the field 
of use of multivalent meningitis vaccines.
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected].

A Method With Increased Yield for Production of Polysaccharide-Protein 
Conjugate Vaccines Using Hydrazide Chemistry

    Description of Technology: Current methods for synthesis and 
manufacturing of polysaccharide-protein conjugate vaccines employ 
conjugation reactions with low efficiency (about twenty percent). This 
means that up to eighty percent of the added activated polysaccharide 
(PS) is lost. In addition, inclusion of a chromatographic process for 
purification of the conjugates from unconjugated PS is required.
    The present invention utilizes the characteristic chemical property 
of hydrazide groups on one reactant to react with aldehyde groups or 
cyanate esters on the other reactant with an improved conjugate yield 
of at least sixty percent. With this conjugation efficiency the 
leftover unconjugated protein and polysaccharide would not need to be 
removed and thus the purification process of the conjugate product can 
be limited to diafiltration to remove the by-products of small 
molecules. The new conjugation reaction can be carried out within one 
or two days with reactant concentrations between 1 and 25 mg/mL at PS/
protein ratios from 1:2 to 3:1, at temperatures between 4 and 40 
degrees Centigrade, and in a pH range of 5.5 to 7.4, optimal conditions 
varying from PS to PS.
    Application: Cost effective and efficient manufacturing of 
conjugate vaccines.
    Inventors: Che-Hung Robert Lee and Carl E. Frasch (CBER/FDA).
    Patent Status: U.S. Patent Application No. 10/566,899 filed 01 Feb 
2006, claiming priority to 06 Aug 2003 (HHS Reference No. E-301-2003/0-
US-10); U.S. Patent Application No. 10/566,898 filed 01 Feb 2006, 
claiming priority to 06 Aug 2003 (HHS Reference No. E-301-2003/1-US-
02); International rights available.
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected].

    Dated: October 14, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-25220 Filed 10-22-08; 8:45 am]
BILLING CODE 4140-01-P