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15kD Granulysin for Monocyte Differentiation: A New Immunotherapeutic for Both in vivo and ex vivo Applications

Researchers at the NCI have developed a method of enhancing immune response in patients by using 15 kD granulysin. Granulysin, a proinflammatory molecule, is broadly applicable for the treatment of several diseases.
NIH Reference Number
Product Type
  • granulysin, immunotherapy
Collaboration Opportunity
This invention is available for licensing and co-development.
Description of Technology

Granulysin is a cytolytic and proinflammatory molecule expressed by activated human cytotoxic T lymphocytes (CTLs) and natural killer (NK) cells. It has been implicated in many of diseases including infection, cancer, transplantation, autoimmunity, skin and reproductive maladies. Small synthetic forms of granulysin are being developed as novel antibiotics and studies suggest that granulysin may be a useful diagnostic biomarker and/or therapeutic for a wide variety of diseases.

The invention relates to methods of stimulating or enhancing an immune response using 15 kD granulysin. Investigators at the NIH have discovered that 15 kD granulysin (but not 9 kD granulysin) activates monocytes and induces them to differentiate into mature dendritic cells and activates allospecific T cells. This activation and subsequent differentiation induced by 15 kD granulysin may prove important in inducing or regulating immune responses in a host. Consequently, this invention could be used to treat tumors and infections, particularly as an adjuvant for vaccines and immunotherapies. Further, this technology could be used to treat autoimmune disorders and organ transplant rejection.

The National Cancer Institute, Laboratory of Cellular and Molecular Biology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology.

Potential Commercial Applications

• Stimulating immunity to vaccinations, tumors or infections
• Blocking the induction of an immune response in an autoimmune disease or organ transplant rejection

Competitive Advantages

• An immune response activator with broad applicability to the treatment of several diseases, including cancer, atherosclerosis, diabetes, autoimmune disorders, allergies, and infections
• Co-administering 15kD granulysin could increase the efficacy of vaccines and immunotherapeutics


Alan M Krensky (NCI), Carol Clayberger (NCI)

Development Stage

Stenger S, et al. An antimicrobial activity of cytolytic T cells mediated by granulysin. [PMID 9756476]

Castiello L, et al. 15 kDa Granulysin versus GM-CSF for monocytes differentiation: analogies and differences at the transcriptome level. [PMID 21501511]

Tewary P, et al. Granulysin activates antigen-presenting cells through TLR4 and acts as an immune alarmin. [PMID 20660289]

Patent Status
  • U.S. Patent Issued: U.S. Patent Number 8815229, Issued 26 Aug 2014
  • U.S. Patent Issued: U.S. Patent Number 9385285, Issued 07 Jun 2016
  • Foreign Filed: Foreign Filed - Patent Application PCT/US2010/052036, Filed 08 Oct 2010
  • Foreign Issued: Australia - Patent Number 2010307075, Issued 02 Apr 2015
  • Foreign Filed: Canada - Patent Application 2777400, Filed 08 Oct 2010
  • U.S. Patent Filed: U.S. Patent Application Number 15/174,402, Filed 06 Jun 2016
Therapeutic Area
Tuesday, October 10, 2017