SUPPLEMENTARY INFORMATION:

Technology description follows:

Human Monoclonal Antibodies That Target the RH5 Complex of Blood-Stage Plasmodium Falciparum

Description of Technology

249 million people were afflicted with malaria in 2022. There are five Plasmodium parasite species that cause malaria in humans. Of the five, Plasmodium falciparum causes most of the incidence of human disease. Most advanced malaria vaccine candidates can confer only partial, short-term protection in malaria-endemic areas. The pathogenesis of malaria is associated with blood-stage infection and antibodies specific to the parasite blood-stage antigens may be able to control parasitemia. To address this public health need, NIAID inventors have developed 35 human monoclonal antibodies that target the RH5 complex of blood-stage Plasmodium falciparum and were found to have potent activity in in vitro growth inhibition assays.

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

• Method of prophylactic and/or therapeutic treatment by targeting blood-stage antigens ofPlasmodium.

Competitive Advantages

• Most other commercially available antibodies targeting againstPlasmodium target circumsporozoite protein (CSP) present in the sporozoite stage. These novel antibodies instead target a conserved and essential antigen present in the blood stage: RH5.
• These monoclonal antibodies can be used alone or in combination with existing antibodies.

Developmental Stage

• Pre-clinical.

Inventors: Joshua Tan, Ph.D., Lawrence Wang, Ph.D. and Andrew Cooper, Ph.D., all of NIAID.

Publications: Wang, L., Cooper, A., et al. “Natural malaria infection elicits rare but potent neutralizing antibodies to the blood-stage antigen RH5.” bioRxiv. https://www.biorxiv.org/​content/​10.1101/​2023.10.04.560669v1, October 06, 2023.

Intellectual Property: HHS Reference No. E-014-2023; Provisional Patent Application No.: 63/468,740.

Licensing Contact: To license this technology, please contact Dawn Taylor-Mulneix at 301-451-8021 or dawn.taylor-mulneix@nih.gov, and reference E-014-2023.

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 Dawn Taylor-Mulneix at 301-451-8021 or dawn.taylor-mulneix@nih.gov.

89 FR 32454