Changeflow GovPing Healthcare & Life Sciences NIH WNV Monoclonal Antibodies Available for Lic...
Routine Notice Added Final

NIH WNV Monoclonal Antibodies Available for Licensing

Favicon for www.federalregister.gov FR: National Institutes of Health
Published
Detected
Email

Summary

NIAID, a component of the NIH, is making five novel neutralizing human monoclonal antibodies targeting West Nile virus (WNV) available for commercial licensing under 35 U.S.C. 209 and 37 CFR Part 404. The antibodies, which bind the WNV envelope protein, are in pre-clinical stage and are available alone or in combination, with accompanying nucleic acids, vectors, and host cells for production. HHS Reference No. E-200-2024-0 covers U.S. Provisional Patent Application (filed July 31, 2024) and PCT Application No. PCT/US2025/039922 (filed July 30, 2025).

Published by Health and Human Services Department on federalregister.gov . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

The NIH Technology Transfer and Intellectual Property Office published a notice announcing that five human monoclonal antibodies neutralizing West Nile virus, developed by NIAID's Vaccine Research Center in collaboration with Sheba Medical Center, are available for licensing to achieve commercialization of federally funded R&D results. The technology includes compositions comprising the antibodies alone or in combination, encoding nucleic acids, vectors, host cells for production, and methods for preventing, treating, or detecting WNV infection.

Commercial entities, particularly pharmaceutical and biotechnology companies with infectious disease or immunotherapy programs, may contact Brian Bailey (240-669-5128 / bbailey@mail.nih.gov) referencing E-200-2024-0 to negotiate licensing. A signed Confidential Disclosure Agreement is required to receive unpublished information. Parties interested in collaborative research to further develop or evaluate the technology may also contact the same representative.

Archived snapshot

Apr 22, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Notice

Government-Owned Inventions; Availability for Licensing

A Notice by the National Institutes of Health on 04/22/2026

  • PDF

  • Document Details

- Table of Contents

  • Public Comments
  • Regulations.gov Data

- Sharing

  • Print
  • Other Formats
  • Public Inspection Published Document: 2026-07769 (91 FR 21508) Document Headings ###### Department of Health and Human Services
National Institutes of Health

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the invention listed below, which 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:

Inquiries related to this licensing opportunity should be directed to: Brian Bailey at 240-669-5128, or bbailey@mail.nih.gov. 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.

SUPPLEMENTARY INFORMATION:

Technology descriptions follows:

Neutralizing Monoclonal Antibodies Against West Nile Virus.

Description of Technology

West Nile virus (WNV) is a mosquito-borne flavivirus that can cause fever and, in some cases, severe neurologic disease. There is no approved human vaccine or specific antiviral treatment for WNV.

Researchers at NIAID's Vaccine Research Center (VRC), working with collaborators at Sheba Medical Center under the PREMISE program, identified five new human monoclonal antibodies that potently neutralize WNV. These antibodies bind the viral envelope (E) protein, with data indicating recognition of E dimers or quaternary epitopes on the virion.

The invention includes compositions comprising the antibodies alone or in combination, nucleic acids encoding them, vectors and host cells for production, and methods for preventing, treating, or detecting WNV infection. The antibodies may be formulated for therapeutic administration, including emergency-use settings, and may also support diagnostic and research applications.

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

  • Prevention or treatment antibodies for WNV, including use alone or in combination.
  • Antibodies that strongly target the WNV E protein.
  • Potential treatments for WNV outbreak response and prevention in high-risk populations.
  • Genetic and cell-engineering tools for antibody production and product development.
  • Antibodies for WNV detection, surveillance, and research tests.
  • Potential intravenous treatments for patients with WNV.

Competitive Advantages

  • Shown to strongly neutralize WNV at low concentrations in laboratory cell-based studies.
  • Novel antibodies with distinct molecular features not previously reported in scientific literature.
  • Human monoclonal antibodies targeting E dimer or quaternary epitopes on the WNV virion.
  • Potential applications in WNV treatment, diagnostics, and surveillance.
  • Collaboration may help speed development to support WNV outbreak response.

Development Stage

  • Pre-Clinical Inventors: Dr. Daniel Douek, Dr. Chaim Schramm, Dr. Ananda Chowdhury, Dr. Parker Dabbs, Dr. Lu Wang, Dr. Sarah Smith, Dr. Leonid Serebryannyy, Dr. Theodore C. Pierson, Dr. Kimberly Dowd, Dr. Katherine Burgomaster, Dr. Laura Vanblargan, Dr. David Gordon, and Dr. Yuxiang Wang, all of NIAID; Dr. Yaniv Lustig, Dr. Yael ( printed page 21509) Ottolenghi, and Dr. Dror Harats, all of Sheba Medical Center.

Publications: n/a.

Intellectual Property: HHS Reference No. E-200-2024-0. U.S. Provisional Patent Application filed on July 31, 2024, and PCT Patent Application No. PCT/US2025/039922, filed on July 30, 2025.

Licensing Contact: To license this technology, please contact Brian Bailey at 240-669-5128, or bbailey@mail.nih.gov, and reference E-200-2024-0.

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 Brian Bailey at 240-669-5128, or bbailey@mail.nih.gov.

Dated: April 17, 2026.

Surekha Vathyam,

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

[FR Doc. 2026-07769 Filed 4-21-26; 8:45 am]

BILLING CODE 4167-05-P

Published Document: 2026-07769 (91 FR 21508)

Citations

35 U.S.C. 209 statutory authority for government-owned invention licensing
37 CFR part 404 implementing regulations for licensing of government-owned inventions

Get daily alerts for FR: National Institutes of Health

Daily digest delivered to your inbox.

Free. Unsubscribe anytime.

About this page

What is GovPing?

Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission

What's from the agency?

Source document text, dates, docket IDs, and authority are extracted directly from Health and Human Services Department.

What's AI-generated?

The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.

Last updated

Classification

Agency
Health and Human Services Department
Published
April 22nd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
91 FR 21508

Who this affects

Applies to
Pharmaceutical companies Biotechnology companies
Industry sector
3254.1 Biotechnology
Activity scope
Technology licensing IP commercialization Research collaboration
Geographic scope
United States US

Taxonomy

Primary area
Intellectual Property
Operational domain
Regulatory Affairs
Topics
Public Health Pharmaceuticals

Get alerts for this source

We'll email you when FR: National Institutes of Health publishes new changes.

Free. Unsubscribe anytime.

You're subscribed!