2024-05881. 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 [e-mail]. 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. [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to the invention.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 [e-mail]. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications related to the invention.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 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 [e-mail], 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 [e-mail].

Dated: March 14, 2024.

Surekha Vathyam,

Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases.