Humanigen Inc. (HGEN) Expands its anti-GM-CSF Patent Portfolio

Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”) a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, today announced the company has been awarded two patents by the United States Patent and Trademark Office (USPTO). These two patents expand Humanigen’s patent portfolio and demonstrate the value of the company’s pioneering approach to neutralizing granulocyte-macrophage colony-stimulating factor (GM-CSF).

“These two patents underscore the value of GM-CSF as a target in decreasing the levels of cytokines/chemokines that limit the efficacy of immunotherapy and contribute to immune-related toxicity in patients undergoing T-cell engaging therapies including CAR-T cell therapy. This also validates our approach to other disease areas where cytokine storm plays a critical role, including COVID-19 and acute graft-versus-host disease,” said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. “Through Humanigen’s Humaneered® technology, lenzilumab, a recombinant human GM-CSF antagonist, is now recognized as a unique and important tool for improving the efficacy of immunotherapy while reducing immune-related toxicity. Together, these patents continue to solidify Humanigen’s robust intellectual property portfolio which includes over 100 issued patents and over 50 patent applications.”

Lenzilumab binds to and neutralizes GM-CSF, which is a key initiator of the inflammatory cascade triggering immunotherapy-related toxicities, including cytokine storm (cytokine response syndrome, “CRS”) and neurotoxicity. These conditions are associated with prolonged hospitalization and intensive care unit stay.1,2 The pro-inflammatory activities of GM-CSF are upstream of other pro-inflammatory cytokines and chemokines such as TNF, interleukin (IL)-6, and IL-23, among others, and can perpetuate a positive feedback loop which further elevates these inflammatory mediators.3,4 We believe that neutralizing the activity of GM-CSF signaling reduces down-stream pro-inflammatory mediators and abrogates CRS, while improving T-cell function by reducing myeloid driven T-lymphocyte suppression.

The first patent, titled METHOD OF REDUCING THE LEVEL OF NON-GM-CSF CYTOKINES/CHEMOKINES IN IMMUNOTHERAPY-RELATED TOXICITY (US 10,899,831 B2), issued January 26, 2021, covers the use of a recombinant human GM-CSF antagonist (lenzilumab) for: a) reducing relapse rate or preventing occurrence of tumor relapse during immunotherapy in the presence or absence of immunotherapy-related toxicity; b) reducing cytokine or chemokine levels other than GM-CSF during immunotherapy-related toxicity; and c) treating or preventing immunotherapy-related toxicity associated with adoptive cell transfer, including chimeric antigen receptor-expressing T-cells (CAR T-cells), T-cell receptor (TCR) modified T-cells, tumor-infiltrating lymphocytes (TILs), chimeric antigen receptor (CAR)-modified natural killer cells, or combination thereof; administration of monoclonal antibodies; administration of cytokines; administration of a cancer vaccine; T-cell engaging therapies; or any combination thereof.

The second patent, titled METHOD OF REDUCING TUMOR RELAPSE RATE IN IMMUNOTHERAPY BY ADMINISTRATION OF LENZILUMAB (US 10,927,168 B2), issued February 23, 2021, covers the use of lenzilumab for reducing relapse rate or preventing occurrence of tumor relapse during immunotherapy, as well as treating or preventing immunotherapy-related toxicity associated with adoptive cell transfer, including chimeric antigen receptor-expressing T-cells (CAR-T cells), T-cell receptor (TCR) modified T-cells, tumor-infiltrating lymphocytes (TILs), chimeric antigen receptor (CAR)-modified natural killer cells, or combination thereof; administration of monoclonal antibodies; administration of cytokines; administration of a cancer vaccine; T-cell-engaging therapies; or any combination thereof.

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