[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Pages 55906-55907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24469]


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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 invention listed below is owned by an agency of the U.S. 
Government and is available for licensing 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: James M. Robinson, 301-761-7542; 
[email protected]. Licensing information and copies of the patent 
application listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD, 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Methods for diagnosing and treating Mycobacterium tuberculosis 
(Mtb) infection through detection of CD153 expression level.
    Description of Technology:
    Mycobacterium tuberculosis (Mtb) infection continues to be the 
leading cause of death due to a single infectious agent and poses 
significant global health challenges. Past research has shown that CD4 
T cells are essential for resistance to Mtb infection, and for decades 
it has been thought that IFN([gamma]) production is the primary 
mechanism of CD4 T cell-mediated protection.
    NIAID researchers have discovered that the expression of TNF 
superfamily molecule CD153 (TNSF8) is required for control of the 
pulmonary Mtb infection by CD4 T cells. The results have shown that, in 
Mtb infected mice, CD153 expression is highest on Ag-specific Th1 cells 
in the lung tissue parenchyma. On the contrary, CD153 deficient mice 
have developed high pulmonary bacterial loads and succumb early to Mtb 
infection. In Mtb infected non-human primates, CD153 expression is much 
higher on Ag-specific CD4 T cells in the

[[Page 55907]]

airways compared to the blood, and the frequency of Mtb-specific CD153-
expressing CD4 T cells inversely correlates with bacterial loads in 
granulomas. Further, in Mtb infected humans, CD153 defines a subset of 
highly polyfunctional Mtb-specific CD4 T cells that are much more 
abundant in individuals with controlled latent Mtb infection compared 
to those with active TB. Since the expression of CD153 by CD4 T cells 
is a major immune mechanism of host protection against Mtb infection, 
the discovery can be used to effectively diagnose and treat Mtb 
infections in the future.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.
    Potential Commercial Applications:
     Mycobacterium tuberculosis diagnostic that measures the 
production of CD153 as an indicator of the disease and its severity
     A companion diagnostic can be used to determine the 
effectiveness of a vaccine against a Mycobacterium tuberculosis 
infection in a subject
     Therapeutic use to treat Mycobacterium tuberculosis in a 
subject
    Competitive Advantages:
     Ability to be used as a target for Mtb diagnostics and 
therapeutics
    Development Stage:
     Proof of concept in animal models and human subject.
    Inventors: Daniel L. Barber (NIAID), Michelle A. Sallin (NIAID), 
Keith D. Kauffman (NIAID)
    Publications: Sallin, Michelle A., et al. ``Host resistance to 
pulmonary Mycobacterium tuberculosis infection requires CD153 
expression.'' Nature microbiology (2018): 1.
    Intellectual Property: HHS Reference No. E-085-2018 US Patent 
Application No. 62/633,816 filed February 2, 2018
    Licensing Contact: James M. Robinson, 301-761-7542; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize the methods of treating human 
tuberculosis. For collaboration opportunities, please contact James M. 
Robison at 301-761-7542 or [email protected].

    Dated: October 31, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-24469 Filed 11-7-18; 8:45 am]
 BILLING CODE 4140-01-P