[Federal Register Volume 65, Number 174 (Thursday, September 7, 2000)]
[Notices]
[Page 54287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22882]


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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, DHHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by agencies 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.

A High Yield Pertussis Vaccine Production Strain and Method for 
Making Same

Tod J. Merkel, Jerry M. Keith and Xiaoming Yang (NIDCR)
DHHS Reference No. E-159-99/0 filed 26 Jun 2000
Licensing Contact: Uri Reichman; 301/496-7736 ext. 240; e-mail: 
[email protected]

    Pertussis Toxin (PT) in its chemically detoxified forms has emerged 
as the most promising acellular vaccine against Bordetella pertussis 
(B. pertussis), the organism responsible for whooping cough. 
Genetically detoxified forms of PT have recently been demonstrated as 
potential vaccine candidates against this organism, and may offer the 
advantages of enhanced stability and ease of manufacturing. The need 
for production of large quantities of PT and its genetically detoxified 
forms keeps growing, but the current methods of production of the toxin 
from B. pertussis have proven to be rather cumbersome and inefficient, 
resulting in poor yields and impure form of the desired protein. The 
present invention provides for a new way to circumvent these 
difficulties and renders the process more amenable to industrial needs. 
The present invention describes the development of a new genetically 
engineered strain of Bordetella bronchiseptica, named BBPT, which grows 
at a high rate relative to B. pertussis, and is capable of producing 
wild type or genetically detoxified form of PT in pure form, with high 
yields and in a cost effective fashion. The high degree of purity of 
the product is achieved due to the knockout of the filamentous 
hemagglutinin (FHA) gene in this new strain. The presence of the FHA 
protein, which is inherent in the conventional methods of production, 
requires extra purification steps, thus resulting in poor and 
inconsistent yields of the toxin. The BBPT strain of the present 
invention may play a major role in the acceleration of programs 
dedicated to the development of improved and efficacious vaccines 
against B. pertussis.

Activation of Antigen Presenting Cells to Respond To a Selected 
Antigen

Polly Matzinger, Stefania Gallucci, Martijn Lolkema (NIAID)
DHHS Reference No. E-018-00/0 filed 25 Oct 1999
Licensing Contact: Peter Soukas; 301/496-7056 ext. 268; e-mail: 
[email protected]

    The inventors have found that alpha interferon and the supernatant 
of necrotic cells can act as adjuvants when co-injected along with a 
protein, such as OVA, to initiate a primary in vivo immune response in 
mice. The compositions of the present invention can induce dendritic 
cells to activate and become good Antigen Presenting Cells (APCs) and 
consequently initiate an immune response. The advantage of these 
adjuvants is that they are more physiological and they allow for 
repeated vaccination, which current adjuvant technology makes difficult 
due to the side effects of the adjuvants. The invention also provides 
uses and applications for the adjuvants, including, but not limited to, 
transplant rejection, spontaneous tumor rejection, some forms of 
spontaneous abortion, and some forms of autoimmunity. The invention is 
further described in Nature Medicine 1999 Nov; 5(11):1249-55.

    Dated: August 29, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 00-22882 Filed 9-6-00; 8:45 am]
BILLING CODE 4140-01-P