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Government-Owned Inventions; Availability for Licensing and Collaboration

---
identifier: "/us/fr/2023-20479"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Government-Owned Inventions; Availability for Licensing and Collaboration"
title_number: 0
title_name: "Federal Register"
section_number: "2023-20479"
section_name: "Government-Owned Inventions; Availability for Licensing and Collaboration"
positive_law: false
currency: "2023-09-21"
last_updated: "2023-09-21"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2023-20479"
document_type: "notice"
publication_date: "2023-09-21"
agencies:
  - "Health and Human Services Department"
  - "National Institutes of Health"
fr_citation: "88 FR 65183"
fr_volume: 88
fr_action: "Notice."
---

#  Government-Owned Inventions; Availability for Licensing and Collaboration

**AGENCY:**

National Institutes of Health, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The invention described below presents an advancement concerning osteoclast fusion; osteoclasts are responsible for human skeletal remodeling and their dysfunction is a key factor for both rare and common bone diseases. The invention covers methods for modulating osteoclast fusion and bone resorption through the Lupus autoantigen (La) protein. The *Eunice Kennedy Shriver* National Institute of Child Health and Human Development (NICHD), National Institutes of Health, has conducted conceptual *in-vitro* studies and is now seeking potential licensees and collaborators for further development and advancement.

**ADDRESSES:**

Inquiries relating to this licensing and collaboration opportunity should be directed to: Heather Gunas, JD, MPH, Senior Technology Transfer Manager, National Cancer Institute (NCI) Technology Transfer Center, 9609 Medical Center Drive, Room 1E446, Rockville, MD 20850 ( *for overnight mail* ) or Bethesda, MD 20892 ( *for regular mail* ), Telephone: (240) 276-5530; Facsimile: (240) 276-5504; Email: *[email protected]* . A Confidential Disclosure Agreement will be required to receive copies of unpublished information regarding this invention.

**SUPPLEMENTARY INFORMATION:**

The following and all continuing U.S. and foreign patents/patent applications thereof are available for licensing: PCT Application No. PCT/US22/018639, filed March 3, 2022, and entitled “La protein as a novel regulator of osteoclastogenesis.” The Lupus autoantigen (La) protein is a master regulator of osteoclasts. The technology involves a novel mechanism for precise regulation of osteoclastogenesis through the manipulation of surface La protein. The ability of osteoclasts to remodel bone can be modulated by: (1) administering an effective amount of La protein or (2) administering an agent that modulates La protein expression or activity. Current solutions for bone diseases are usually broad-spectrum treatments that either coat the skeletal system or inhibit osteoclast development and these approaches can result in off-target side effects. This technology's approach to regulating osteoclast fusion and osteoclastogenesis by targeting the La protein should bypass many side effects. The technology has been supported by conceptual *in-vitro* data and lead optimization is ongoing; further research and development are required to advance it towards disease-specific preclinical and clinical stages.

*Potential Commercial Application:* Treatment of common and rare bone diseases, including osteoporosis, Paget's disease of bone, fibrous dysplasia, rheumatoid arthritis, osteopetrosis, osteomyelitis, or metastatic bone disease.

*Development Stage: In-vitro* study completed and lead optimization ongoing.

Dated: September 18, 2023.

Richard U. Rodriguez,

Associate Director, Technology Transfer Center, National Cancer Institute.