[Federal Register Volume 85, Number 220 (Friday, November 13, 2020)]
[Notices]
[Pages 72673-72674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25098]


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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: Dianca Finch, Ph.D., 240-669-5503; 
[email protected]. Licensing information and copies of the U.S. 
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to receive copies of unpublished patent applications.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:

Identification of a New Human Monoclonal Antibody That More Potently 
Prevents Malaria Infection

    Description of Technology:
    Malaria is a major disease caused by a parasite transmitted through 
the bite of infected female mosquitoes. Globally, an estimated 214 
million cases of malaria and 438,000 deaths from malaria occur 
annually, with chidren in African and South Asian regions being most 
vulnerable. Approximately 1,500-2,000 cases of malaria are reported in 
the United States each year, mostly in returning travelers from 
malaria- endemic countries. Among the international travelers, military 
personnel, diplomats, pregnant women, children and older individuals 
with weakened immune systems are more likely to be at risk of malaria 
infection and mortality.
    Currently, there is no licensed vaccine against Plasmodium 
falciparum, the deadliest species of malaria parasites. Antibodies can 
prevent malaria infection by binding to sporozoites, the infectious 
form of P. falciparum that is transmitted to humans by the bites of 
infected mosquitoes. The major target of anti-sporozoite antibodies is 
the P. falciparum circumsporozoite protein (PfCSP), an abundant surface 
protein on sporozoites that is essential for infecting liver cells, 
which is the critical step for initiating a productive infection. PfCSP 
is comprised of an N-terminal domain, a central region and the C-
terminal region.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases (NIAID)

[[Page 72674]]

have isolated a new neutralizing recombinant human monoclonal antibody, 
L9, from a protected volunteer immunized with whole Plasmodium 
falciparum sporozoites. L9 is notable for targeting PfCSP, the 
immunodominant immunogen that coats the surface of the sporozoite, 
specifically the Plasmodium infectious form injected into the human 
host by the mosquito. Also, in vivo studies in a mouse model of malaria 
infection demonstrated that L9 is more potent than CIS43, another 
antimalarial mAb, at preventing malaria infection.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.
    Potential Commercial Applications:
     A passive vaccine candidate to prevent and eradicate 
malaria.
    Competitive Advantages:
     L9 may represent a more attractive passive vaccine 
candidate to advance through clinical testing and could yield a product 
superior to other vaccine candidates due to potency and preferential 
binding to unique epitopes on PfCSP.
     L9 may result in more durable protection than other 
vaccine candidates.
    Development Stage: Preclinical Research.
    Inventors: Robert Alan Seder (NIAID); Lawrence Tsuchun Wang 
(NIAID); Rachel Marie Vistein (NIAID); Joseph Richard Francica (NIAID).
    Publications: Wang, L. T., et al. (2020). A Potent Anti-Malarial 
Human Monoclonal Antibody Targets Circumsporozoite Protein Minor 
Repeats and Neutralizes Sporozoites in the Liver. Immunity.
    Intellectual Property: HHS Reference Number E-087-2019 includes PCT 
Patent Application Number PCT/US2020/031345 filed on 05/04/2020.
    Licensing Contact: To license this technology, please contact 
Dianca Finch, Ph.D., 240-669-5503; [email protected].

    Dated: November 6, 2020.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-25098 Filed 11-12-20; 8:45 am]
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