[Federal Register Volume 86, Number 71 (Thursday, April 15, 2021)]
[Notices]
[Pages 19895-19896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07709]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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: Dawn Taylor-Mulneix at 301-767-5189 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unpublished information related to the invention.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:

[[Page 19896]]

Human Monoclonal and Bispecific Antibodies Targeting SARS-CoV-2 
Coronavirus

Description of Technology

    SARS-CoV-2 is a virus of the Coronavirus family that has emerged as 
a major public health concern. The first cases of SARS-CoV-2 were 
reported in China and rapidly spread worldwide leading to a global 
pandemic. The highest morbidity and mortality have been reported in the 
elderly and immunocompromised. Antibody therapeutics have great 
importance for advanced cases of SARS-CoV-2 where a vaccine would not 
be effective and may be more effective than a vaccine in certain high-
risk populations.
    Scientists at NIAID have developed recombinant monoclonal 
antibodies that are effective in vitro and in vivo at neutralizing 
SARS-CoV-2. Based on whether they are mono-specific or bi-specific and 
where they bind to the SARS-CoV-2 virus, these antibodies can be 
subdivided into four groups that target (A) the receptor-binding-domain 
(RBD) of the SARS-COV-2 spike protein, (B) the N-terminal domain (NTD) 
of the SARS-COV-2 spike protein, (C) dual locations on the RBD, or (D) 
both the RBD and NTD. Crucially, these antibodies effectively 
neutralize the emerging B.1.1.7 and B.1.351 SARS-CoV-2 variants of 
concern.
    These recombinant monoclonal antibodies can be used alone, in 
combination, or with other therapeutics for the treatment of SARS-COV-
2. In addition to their potential as therapeutics, these antibodies 
against SARS-CoV-2 can be used as prophylactics and in assay 
development. They can contribute to the surveillance, diagnosis, and 
prevention of SARS-COV-2. Furthermore, the specific antibody sequences 
and targets will inform vaccine development and establishment of long-
term immunity.
    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

     Prophylaxis or therapeutics against SARS-CoV-2.
     Diagnostics and surveillance of SARS-CoV-2.
     Vaccine research.

Competitive Advantages

     Potent neutralizing activity against SARS-CoV-2, including 
against B.1.1.7 and B.1.351 variants.
     Prophylactic usage against SARS-CoV-2 in normal or high-
risk populations.
     Therapeutic treatment, alone or in combination, in 
patients with SARS-CoV-2 infection.
     Assay development for surveillance, diagnostic, and 
prevention measures.
     Identification of vaccine candidates which elicit 
protective antibodies against SARS-CoV-2 infections.

Development Stage

     Pre-clinical.
    Inventors: Joshua Tan, Ph.D., Peter Crompton, M.D., Hyeseon Cho, 
Ph.D., Mary Peterson, Kristina Kay Gonzales-Wartz, Ph.D., all of NIAID.
    Publications: Cho, Hyeseon, et al. ``Ultrapotent bispecific 
antibodies neutralize emerging SARS-CoV-2 variants.'' bioRxiv 
2021.04.01.437942;
    Intellectual Property: HHS Reference No. E-030-2021-0; US 
provisional application No. 63/127,077 filed on December 17, 2020.
    Licensing Contact: To license this technology, please contact Dawn 
Taylor-Mulneix 301-767-5189 or [email protected], and 
reference E-030-2021-0.
    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 Dawn Taylor-Mulneix at 301-767-5189 or 
[email protected].

    Dated: April 7, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-07709 Filed 4-14-21; 8:45 am]
BILLING CODE 4140-01-P