[Federal Register Volume 89, Number 74 (Tuesday, April 16, 2024)]
[Notices]
[Page 26900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08013]



[[Page 26900]]

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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: 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unpublished information related to the invention.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:

Human Monoclonal Antibodies That Target Plasmodium Falciparum 
Sporozoites

Description of Technology

    Malaria is one of the world's deadliest infectious diseases, 
causing an estimated 249 million cases and 608,000 deaths annually, 
with children in the regions of Africa and South Asia being most 
vulnerable. Approx 2,000 cases of malaria are reported in the United 
States each year, by travelers from malaria-risk countries. Malaria is 
a mosquito-borne parasitic disease transmitted through the bite of 
infected female mosquitoes, which introduces Plasmodium sporozoites 
into the bloodstream of the human host. There are five Plasmodium 
parasite species that cause malaria in humans, of which, the vast 
majority of life-threatening cases are caused by infection with 
Plasmodium falciparum parasites.
    Researchers at NIAID have developed 11 human monoclonal antibodies 
that bind to a unique site on the circumsporozoite protein (CSP) on 
Plasmodium falciparum sporozoites that is not targeted by any known 
monoclonal antibodies. These antibodies do not bind to recombinant 
forms of CSP and as such bind to a processed or post-translational form 
of the protein processed by the sporozoites. In vivo studies have shown 
several of these antibodies can substantially reduce liver parasite 
burden in a mouse model of malaria. These antibodies can work 
cooperatively with known antibodies that target the repeat region of 
CSP. Some of these novel antibodies have shown enhanced protection in 
an animal model when combined with known protective monoclonal 
antibodies against sporozoites, suggesting that together they may form 
an effective cocktail to prevent malaria.
    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

     Prophylactic and preventative treatment against malaria.

Competitive Advantages

     These antibodies bind to a unique site on the 
circumsporozoite protein (CSP) on Plasmodium falciparum sporozoites 
that is distinct from the targets of pre-existing mAbs.
     These monoclonal antibodies can be used alone or in 
combination with existing antibodies.

Development Stage

     Pre-Clinical
    Inventors: Joshua Tan, Ph.D., Cherrelle Dacon, Ph.D., both of 
NIAID.
    Publications: n/a.
    Intellectual Property: HHS Reference No. E-212-2022-0. U.S. 
Provisional Patent Application No. 63/409,016, filed on September 22, 
2022, and PCT Patent Application No. PCT/US2023/074791, filed on 
September 21, 2023.
    Licensing Contact: To license this technology, please contact Dawn 
Taylor-Mulneix at 301-767-5189, or [email protected], and 
reference E-212-2022.
    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. Areas of specific 
interest include (a) testing developability of these antibodies (e.g., 
biophysical characteristics, cross-reactivity, pharmacokinetics, 
toxicity), (b) pre-clinical model assessment, and (c) human clinical 
trials. For collaboration opportunities, please contact Dawn Taylor-
Mulneix at 301-767-5189, or [email protected].

    Dated: April 8, 2024.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2024-08013 Filed 4-15-24; 8:45 am]
BILLING CODE 4140-01-P