[Federal Register Volume 89, Number 55 (Wednesday, March 20, 2024)]
[Notices]
[Pages 19856-19857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05881]


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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: Peter Tung at 240-669-5483 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unpublished information related to the invention.
    Licensing information and copies of the patent applications listed 
below 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 by 
contacting Peter Tung at 240-669-5483 or [email protected]. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

Next-Generation MSP1-Targeted Malaria Immunotherapy: Enhanced Vaccine 
Candidates and Monoclonal Antibodies

Description of Technology

    This technology encompasses the development of highly advanced 
malaria vaccine candidates and human monoclonal antibodies, both 
centered on targeting the Merozoite Surface Protein 1 (MSP1) of the 
Plasmodium falciparum malaria parasite. The innovation lies in 
utilizing a novel computational design and in vitro screening process, 
which has created MSP1 vaccine candidates that are significantly more 
immunogenic, stable, and cost-effective than existing alternatives. 
These vaccines focus on the 19 kDa carboxy-terminus fragment of MSP1. 
They contain engineered amino acid changes and are displayed on self-
assembling nanoparticles to elicit a more potent immune response, 
potentially offering more robust and durable protection against 
malaria. Additionally, the technology includes the production of 
enhanced human monoclonal antibodies with improved affinity for the 
same fragment of MSP1, designed to overcome the parasite's immune 
evasion tactics. These advancements hold immense promise for 
significantly improving malaria prevention and treatment. They could 
lead to the development of more

[[Page 19857]]

effective vaccines and therapeutic antibodies, providing a critical 
solution to a significant global health challenge.
    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

     This MSP1-focused technology has the potential to 
transform malaria treatment and prevention worldwide, offering more 
effective vaccines and therapeutic antibodies for use in clinical 
settings, public health programs, and potentially in regions with high 
malaria prevalence.

Competitive Advantages

     This technology offers highly immunogenic and stable MSP1-
based vaccine candidates and monoclonal antibodies, with superior 
efficacy, cost-effectiveness, and ease of production compared to 
current alternatives.

Development Stage

Pre-Clinical
    Inventors: Niraj Tolia, Ph.D., Thayne Dickey, Ph.D., Palak Patel, 
Ph.D., Kazuotoyo Miura, Ph.D., Carole Long, Ph.D., all of NIAID.
    Publications: Patel, Palak N et al. ``Neutralizing and interfering 
human antibodies define the structural and mechanistic basis for 
antigenic diversion.'' Nature communications vol. 13,1 5888. 6 Oct. 
2022, doi:10.1038/s41467-022-33336-3.
    Intellectual Property: HHS Reference No. E-154-2022-0-US-01, US 
Provisional Application No. 63/369,909, filed on July 29, 2022; HHS 
Reference No. E-154-2022-0-PC-01, PCT Application No. PCT/US2023/
070926, filed on July 25, 2023.
    Licensing Contact: To license this technology, please contact Peter 
Tung at 240-669-5483 or [email protected], and reference E-154-2022.
    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. For collaboration 
opportunities, please contact Peter Tung at 240-669-5483 or 
[email protected].

    Dated: March 14, 2024.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2024-05881 Filed 3-19-24; 8:45 am]
BILLING CODE 4140-01-P