Health

Government-Owned Inventions; Availability for Licensing: Human Antibodies With Anti-Lymphocyte Specificities and Lytic Activity

🇺🇸United States··Notice·High Impact·View source ↗

AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.

🇬🇧 English

The National Institute of Allergy and Infectious Diseases (NIAID), part of NIH under HHS, announces availability for licensing of a government-owned invention: human antibodies derived from a patient with idiopathic CD4 lymphocytopenia (ICL). These antibodies target and kill B cells and T cells, showing potent lytic activity against B-cell tumors and normal immune cells. One standout antibody, NIH58.9, eliminates B cells at ultra-low concentrations of 0.01 nanomolar, offering advantages over animal-derived antibodies that risk immune rejection. Developed using advanced genetic sequencing of patient plasma, these fully human IgM antibodies can be used directly, engineered into IgG1 formats, bispecific antibodies, or antibody-drug conjugates. Potential applications include therapies for B-cell lymphomas, autoimmune diseases like lupus and multiple sclerosis, and organ transplantation. The technology is at the pre-clinical stage, with U.S. Provisional Patent Application 63/787,190 filed April 11, 2025 (HHS Reference E-025-2025). Licensing follows 35 U.S.C. 209 and 37 CFR part 404, with contacts via Benjamin Hurley (240-276-5489, benjamin.hurley@nih.gov). A Confidential Disclosure Agreement is required for unpublished details. NIAID also seeks collaborators for further development.

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Key Changes

  • Invention HHS Ref. E-025-2025 available for licensing under 35 U.S.C. 209 and 37 CFR part 404
  • U.S. Provisional Patent 63/787,190 filed April 11, 2025
  • NIH58.9 antibody kills B cells at 0.01 nM concentration

+ 3 more changes with Pro

Obligations

What this law requires

high

Prospective licensees must execute a signed Confidential Disclosure Agreement (CDA) prior to receiving copies of unpublished information related to the invention

Any party seeking to license or receive detailed technical information about the human antibodies invention
disclosure
high

Licensees must comply with 35 U.S.C. 209 and 37 CFR part 404 when licensing this government-owned invention

All licensees of the human antibodies technology
licensing
medium

All licensing inquiries and requests must reference HHS Reference No. E-025-2025 when contacting the Technology Transfer and Intellectual Property Office

Any party seeking to license the invention
operational
medium

Parties interested in collaborative research must submit statements of capability or interest to the NIAID Technology Transfer office

Any party seeking collaborative development, evaluation, or commercialization opportunities
operational
high

Commercial development of the antibody therapies must be conducted in accordance with applicable U.S. patent law and provisional patent application 63/787,190 filed April 11, 2025

All licensees developing monoclonal antibody therapies, bispecific antibodies, or antibody-targeted drugs
licensing

Affected Parties

biotech companiespharmaceutical firms+4 more…

Tags

NIAID,human antibodies,B-cell therapy