2023-01416. 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:

Amy F. Petrik, Ph.D., 240-627-3721; [e-mail]. Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with the indicated licensing contact at 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 A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.

SUPPLEMENTARY INFORMATION:

Technology description follows:

Antibodies With Potent and Broad Neutralizing Activity Against Antigenically Diverse and Highly Transmissible SARS-CoV-2 Variants

Description of Technology: Emergence of highly transmissible SARS-CoV-2 variants of concern that are resistant to current therapeutic antibodies highlights the need for continuing discovery of broadly reactive antibodies.

Scientists at the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases have identified multiple antibodies that ultra-potently neutralize SARS-CoV-2, including the highly transmissible BA.4, BA.5, BQ.1.1 and XBB subvariants of Omicron, as shown in a pseudovirus neutralization assay. These antibodies target several epitopes in the receptor binding domain of the spike protein that are not impacted by spike mutations that knockout binding to other therapeutic antibodies, including, K417N, N439K, N440K, K444T, V445P, G446S, L452R, Y453F, N460K, S477N, E484A/K, F486S/V and Q498R. Several of the antibodies are able to simultaneously bind to the spike protein and are compatible for use in combination therapies.

This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404.

Potential Commercial Applications:

• Treatment of SARS-CoV-2 infection

Competitive Advantages:

• Ultra-potent neutralization of currently identified SARS-CoV-2 variants including Omicron subvariants BQ.1.1 and XBB
• Mechanism of Action—Some antibodies directly bind to and block ACE2 receptor binding to the SARS-CoV-2 spike protein

Development Stage: Preclinical Research.

Inventors: John Misasi (VRC, NIAID), Lingshu Wang (VRC, NIAID), John Mascola (VRC, NIAID), Daniel Douek (VRC, NIAID), Nancy Sullivan (VRC, NIAID), Richard Alan Koup (VRC, NIAID), Man Chen, (VRC, NIAID), Wei Shi (VRC, NIAID), Yi Zhang (VRC, NIAID), Eun Sung Yang (VRC, NIAID), Nicole Doria-Rose (VRC, NIAID), Chaim Schramm (VRC, NIAID), Kevina Maria Nabireka Birungi-Huff (VRC, NIAID), Sabrina Bush (VRC, NIAID), Maryam Musayev (VRC, NIAID).

Publications: None.

Intellectual Property: HHS Reference Number E-024-2023 includes U.S. Provisional Patent Application Number 63/433,719 filed December 19, 2022.

Licensing Contact: To license this technology, please contact Amy F. Petrik, Ph.D., 240-627-3721; [e-mail].

Dated: January 19, 2023.

Surekha Vathyam,

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