[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)]
[Notices]
[Pages 4498-4499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01928]


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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, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S.

[[Page 4499]]

Government and are available for licensing in the U.S.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the patent applications listed below may be obtained by emailing the 
indicated licensing contact at the National Heart, Lung, and Blood, 
Office of Technology Transfer and Development Office of Technology 
Transfer, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479; 
telephone: 301-402-5579. A signed Confidential Disclosure Agreement may 
be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: This notice is in accordance with 35 U.S.C. 
209 and 37 CFR part 404 to achieve 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. A description of the 
technology follows.

Chimeric Antibodies Against Hepatitis B e-Antigen

    Description of Technology: The invention relates to recombinant 
chimeric rabbit/human monoclonal antibody fragments (Fabs) against 
hepatitis B Virus e-antigen (HBeAg), notably Fab me6. Viral hepatitis 
is the seventh leading cause of death worldwide. Hepatitis B core 
antigen (HBcAg) forms an icosahedral structure containing the viral 
genome. Both the HBcAg and the HBeAg of interest here are expressed by 
two different start codons of the viral C gene. Unlike the related 
HBcAg which activates type 1 T helper (Th1) cells leading to immune 
attack, the HBeAg activates Th2 cells which promote immune tolerance. 
The long-term persistence of HBeAg is associated with the development 
of hepatocellular carcinoma. Conversely, HBeAg seroconversion (from 
HBeAg carrier to anti-HBeAg carrier) is a marker for successful therapy 
of chronically infected patients. The presently phage display 
engineered antibody Fab me6 shows higher sensitivity and selectivity 
against HBeAg compared to three commercial diagnostics kits tested; 
additionally, it also inhibits capsid assembly which is essential for 
viral replication; furthermore, it can also be fully humanized and has 
potential for anti-hepatitis B virus therapeutic interventions.
    Potential Commercial Applications:
     Hepatitis B therapy.
     Hepatocellular carcinoma prophylaxis.
    Development Stage:
     In vitro data available.
    Inventors: Paul Winfield, Norman Watts, Alasdair Steven (all of 
NIAMS).
    Intellectual Property: HHS Reference No. E-192-2017/0-US-01.
     U.S. Provisional Patent Application 62/534,603 filed July 
19, 2017.
    Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Environmental Health Sciences seeks statements of capability or 
interest from parties interested in collaborative research to further 
develop and evaluate, please contact Cecilia Pazman, Ph.D., Technology 
Development Specialist, Office of Technology Transfer, National Heart, 
Lung, and Blood Institute, Phone: (301) 594-4273; 
[email protected].

    Dated: January 25, 2018.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2018-01928 Filed 1-30-18; 8:45 am]
BILLING CODE 4140-01-P