2023-20479. 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: [phone]; Facsimile: (240) 276–5504; Email: [e-mail]. A Confidential Disclosure Agreement will be required to receive copies of unpublished information regarding this invention.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.