[Federal Register Volume 89, Number 43 (Monday, March 4, 2024)]
[Notices]
[Pages 15596-15597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04441]


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

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: 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unpublished information related to the invention.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unpublished patent applications related to the invention.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:

Enhanced Single-Component AMA1-RON2 Vaccine Candidates: A Breakthrough 
in Malaria Immunization

Description of Technology

    This technology focuses on the creation of single-component AMA1-
RON2 (Apical membrane antigen 1-rhoptry neck protein 2) vaccine 
candidates. These candidates are based on a novel composition of matter 
designed to elicit a more effective immune response against the malaria 
parasite Plasmodium falciparum. The standout aspect of this technology 
is the Structure-Based Design 1 (SBD1) immunogen, engineered through a 
structure-based design that significantly enhances its ability to 
produce potent, strain-transcending neutralizing antibodies. This 
approach not only surpasses the efficacy of traditional AMA1-RON2 
complexes and other insertion fusion designs but also boasts higher 
thermal stability, indicating better preservation and longevity of the 
vaccine. The technology's increased stability and efficiency in 
production present an opportunity to lower vaccine

[[Page 15597]]

manufacturing costs and simplify logistics, especially in regions where 
malaria is endemic. Additionally, the adaptability of these immunogens 
for integration with nanoparticle platforms could further amplify their 
immunogenicity, paving the way for more robust and lasting protection 
against malaria. This innovation can potentially transform malaria 
prevention and control, offering a more effective, stable, and cost-
efficient solution to a disease that continues to impact millions 
worldwide.
    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

     Stable single-component AMA1-RON2 immunogens hold promise 
for improving malaria prevention and control efforts in endemic regions 
around the world.

Competitive Advantages

     No blood-stage malaria vaccine has been approved. This 
technology offers a competitive edge over other vaccine candidates in 
development through its easily manufactured single-component AMA1-RON2 
design that elicits a potent broadly neutralizing response that is 
better than competing candidates.

Development Stage

     The efficacy of stable single-component AMA1-RON2 
immunogens has been validated in rat and rabbit models. Following 
identification of the most cost-effective platform for vaccine 
production, the immunogens will be advanced for virulent parasite 
challenge studies in Aotus monkeys and towards human trials.
    Inventors: Niraj Tolia, Ph.D., Thayne Dickey, Ph.D., Palak Patel, 
Ph.D., all of NIAID.
    Publications: Patel, P. N. et. al., Structure-based design of a 
strain transcending AMA1-RON2L malaria vaccine. Nat. Commun. 14, 5345 
(2023).
    Intellectual Property: HHS Reference No. E-096-2023-0-US-01US-01; 
US Provisional Application No. 63/524,522, filed on June 30, 2023.
    Licensing Contact: To license this technology, please contact Peter 
Tung at 240-669-5483 or [email protected], and reference E-096-2023.
    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: February 27, 2024.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2024-04441 Filed 3-1-24; 8:45 am]
BILLING CODE 4140-01-P