SUPPLEMENTARY INFORMATION:

Technology description follows:

Respiratory Syncytial Virus (RSV) G and F Specific Antibodies With High RSV-Neutralizing Potency

Description of Technology

RSV is a major cause of serious respiratory illness, particularly in infants, older adults, and people with weakened immune systems. The virus uses the attachment protein G to bind to host cells and the fusion protein F to enter them. Although approved RSV antibody products target F, no licensed antibody currently targets G.

Researchers in NIAID's Laboratory of Infectious Diseases (LID) developed a monoclonal antibody that targets a conserved region of G that may be less likely to change over time. In laboratory tests, the IgG3 subclass of this antibody showed about 9-fold greater neutralizing activity than licensed RSV antibodies. Researchers also created an IgG1 version to see whether the IgG3 subclass contributed to this strong activity. The IgG1 version was slightly less potent than the IgG3 form but still showed strong neutralizing activity. These results suggest that IgG subclass can influence the neutralizing activity of this G-targeting antibody.

This technology could support development of first-in-class antibodies targeting RSV G for the prevention or treatment of RSV disease, including in people at high risk for severe illness. These G-targeting antibodies may also be used in combination with existing F-targeting antibodies to broaden protection and potentially improve efficacy. Ongoing engineering efforts are aimed at improving the stability of the G-targeting antibodies and extending their persistence in the body.

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

• Antibody-based RSV products targeting the attachment protein G that may be used alone or in combination with existing RSV F-targeting antibodies to broaden protection.
• Potential first-in-class antibodies against the RSV G protein for preventing or treating severe disease.

Competitive Advantages

• Target the RSV attachment protein G, for which no licensed antibodies currently exist.
• Bind a conserved region of the G protein that may be less likely to change over time, which could help these antibodies remain effective as the virus evolves.
• IgG3 G-targeting antibody achieves about 9-fold greater neutralizing activity in laboratory tests than currently existing products.

Development Stage

• Pre-Clinical

Inventors: Dr. Ursula Buchholz, Dr. Cyril Le Nouen, and Dr. Laura Ahlers, all of NIAID.

Intellectual Property: HHS Reference No. E-117-2024-0. Provisional Patent Application No. 63/566,064, filed on March 15, 2024, and PCT Patent Application No. PCT/US2025/020070, filed on March 14, 2025.

Licensing Contact: To license this technology, please contact Dawn Taylor-Mulneix at 301-451-8021, or dawn.taylor-mulneix@nih.gov, and reference E-117-2024-0.

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.

91 FR 58689