[Federal Register Volume 87, Number 71 (Wednesday, April 13, 2022)]
[Notices]
[Page 21892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07892]



[[Page 21892]]

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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: Chris Kornak at 240-627-3705 or 
[email protected]. Licensing information may be obtained by 
communicating with 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unpublished information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

Humanized Murine Monoclonal Antibodies That Neutralize Type-1 
Interferon (IFN) Activity

Description of Technology

    Interferons (IFNs) are a family of cytokines that function in 
response to an immune challenge such as a viral or bacterial infection. 
Type I IFNs are produced by immune cells (predominantly monocytes and 
dendritic cells) as well as fibroblasts and signal through a specific 
cell surface receptor complex (IFNAR) that consist of IFNAR1 and IFNAR2 
chains. Type-I IFNs exert several common effects including antiviral, 
antiproliferative, and immunomodulatory activities. However, Type I 
IFNs also have pro-inflammatory effects, especially in the presence of 
TNF-[alpha]. Therefore, neutralizing the pro-inflammatory effect of 
Type I interferon could have wide clinical applications in autoimmune 
diseases like SLE, or in acute and chronic viral diseases like SARS-
CoV-2, HIV or HCV infection, respectively, in which IFN-induced 
inflammation may be detrimental.
    Scientists at the National Institute of Allergy and Infectious 
Diseases (NIAID) have developed two anti-IFN receptor 2 (IFNAR2) 
antibodies, B7 and A10, that are effective in vitro at neutralizing 
Type I IFN activities. The antibodies are comprised of two heavy chains 
and two light chains of amino acids. Both antibodies are able to bind 
to the extracellular domain of IFNAR2, Type I IFN receptor subunit 2, 
thus suppressing IFN signaling.
    Because there are no potent IFNAR2 antibodies for therapies 
commercially available at this time, these antibodies are a novel 
therapeutic tool that could be used exclusively or in combination to 
treat chronic inflammatory diseases (like autoimmune disorders such as 
SLE) in which sustained IFN production may lead to both systemic and 
specific organ dysfunctions or chronic viral diseases (such as HIV, 
HCV) in which sustained IFN production has deleterious effects on 
immunologic function.
    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

    Therapeutics for the treatment of chronic inflammatory conditions:
     In chronic inflammatory diseases (e.g., autoimmune 
disorders such as SLE).
     In chronic viral diseases (such as HIV, HCV infection).
     In acute viral or inflammatory diseases (e.g., SARS-CoV-
2).

Development Stage

     Pre-clinical.
    Inventors: Paolo Lusso, M.D. Ph.D., Hana Schmeisser, Ph.D., Kathryn 
C. Zoon, Ph.D., Qingbo, Liu, Ph.D., all of NIAID.
    Publications:

A.N. Morrow, H. Schmeisser, T. Tsuno, K.C. Zoon. A novel role for 
IFN-stimulated gene factor 3II in IFN-[gamma] induction of antiviral 
activity in human cells. J Immunol 186: 1685-93, 2011.
C.A. Balinsky, H. Schmeisser, S. Ganesan, K. Singh, T.C. Pierson, 
K.C. Zoon. Nucleolin interacts with the dengue virus capsid protein 
and plays a role in formation of infectious virus particles. J Virol 
87: 13094-106, 2013.
H. Schmeisser, S.B. Fey, J. Horowitz, E.R. Fischer, C.A. Balinsky, 
K. Miyake, J. Bekisz, A.L. Snow, K.C. Zoon. Type I interferons 
induce autophagy in certain human cancer cell lines. Autophagy 9: 
683-96, 2013.
L.A. Zaritsky, J.R. Bedsaul, K.C. Zoon. Virus multiplicity of 
infection affects type I interferon subtype induction profiles and 
interferon-stimulated genes. J Virol 89 (22): 11534-48, 2015.
C.A. Balinsky, H. Schmeisser, A.I. Wells, S. Ganesan, T. Jin, K. 
Singh, K.C. Zoon. IRAV (FLJ112886), an interferon stimulated gene 
with antiviral activity against Dengue Virus, interacts with MOV 10. 
J Virol 14: 91(5), e01606-16, 2017.
A.W.T. Chiang, S. Li, B.P. Kellman, G. Chattopadhyay, Y. Zhang, Ch. 
Ch. Kuo, J.M. Gutierrez, F, Ghazi, H. Schmeisser, P. M[eacute]nard, 
S.P. Bj[oslash]rn, B.G. Voldborg, A.S. Rosenberg, M. Puig, Nathan E. 
Lewis. Combating viral contaminants in CHO cells by engineering 
innate immunity. Sci Rep 9 (1), 8827, 2019.

    Intellectual Property: HHS Reference No. E-220-2020-0; U.S. 
provisional application No. 63/094,572 filed on 10/21/2020 and PCT 
application PCT/US2021/056067.
    Licensing Contact: To license this technology, please contact Chris 
Kornak 240-627-3705 or [email protected], and reference E-220-2020.
    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 this technology. For collaboration 
opportunities, please contact Chris Kornak at 240-627-3705 or 
[email protected].

    Dated: April 8, 2022.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2022-07892 Filed 4-12-22; 8:45 am]
BILLING CODE 4140-01-P