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Government-Owned Inventions; Availability for Licensing

---
identifier: "/us/fr/2023-14308"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Government-Owned Inventions; Availability for Licensing"
title_number: 0
title_name: "Federal Register"
section_number: "2023-14308"
section_name: "Government-Owned Inventions; Availability for Licensing"
positive_law: false
currency: "2023-07-07"
last_updated: "2023-07-07"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2023-14308"
document_type: "notice"
publication_date: "2023-07-07"
agencies:
  - "Health and Human Services Department"
  - "National Institutes of Health"
fr_citation: "88 FR 43366"
fr_volume: 88
fr_action: "Notice."
---

#  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:**

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 by contacting Chris Kornak at 240-627-3705 or *[email protected].* A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to the invention.

**SUPPLEMENTARY INFORMATION:**

Technology description follows:

**Dual-Germline Antibody Engager Chimeric HIV-1 Immunogens**

*Description of Technology:* Despite four decades of intensive research, a safe and effective HIV-1 vaccine remains elusive due to the extreme difficulty in eliciting broadly neutralizing antibodies (bNAbs), which recognize and block HIV-1 from entering healthy cells. Only rare natural HIV-1 envelopes (Envs) promote the activation and expansion of naïve B cells expressing unmutated germline antibodies of various bNAb lineages, but they typically do so for a single lineage for the same neutralization site. To overcome this challenge, NIAID has designed and characterized two chimeric HIV-1 Env immunogens capable of simultaneously engaging multiple germline bNAb lineages. Both chimeric Env immunogens maintain native-like folding and engage two lineages of germline bNAbs directed against two independent sites of HIV-1 vulnerability.

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:*

*Immunization:* The dual-germline engager HIV-1 immunogens could be employed during the priming phase of an HIV vaccine to trigger multiple bNAb lineages simultaneously, resulting in a multi-target protective antibody response.

*Clinical Treatment:* The dual-germline engager HIV-1 immunogens could serve as an alternative to current anti-retrovirals or incorporated into current HIV treatment strategies.

*Competitive Advantages:*

• Dual-germline engager HIV-1 Env immunogens are inherently superior to the currently available single-germline engagers for eliciting bNAbs.

• The chimeric design could be expanded to generate HIV-1 Env trimers with even more germline bNAb specificities to enable a broader immunogenic response against HIV.

*Inventors:* Peng Zhang, Ph.D., Paolo Lusso, M.D., Ph.D., both of NIAID.

*Publications:* Publication pending.

*Intellectual Property:* HHS Reference No. E-140-2022; US Provisional Application No. 63/397,789.

*Licensing Contact:* To license this technology, please contact Chris Kornak at 240-627-3705 or *[email protected],* and reference E-140-2022.

*Collaborative Research Opportunity:* The Technology Transfer and Intellectual Property Office is seeking parties interested in collaborative research to further develop this technology by manufacturing non-MRNA virus-like particles incorporating dual germline engager HIV-1 immunogens and subsequently testing immunogenicity in non-human primates. For collaboration opportunities, please contact Chris Kornak; 240-627-3705, *[email protected].*

Surekha Vathyam,

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