Dec. 28, 2020 12:00 UTC

BURLINGAME, Calif.--(BUSINESS WIRE)-- 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 United States Patent and Trademark Office has issued a patent to the Company for the use of lenzilumab in prevention or treatment of cytokine storm and neurotoxicity in patients undergoing chimeric antigen receptor T (CAR-T) cell therapy.

The patent covers the use of lenzilumab to prevent or treat cytokine release syndrome (CRS), neurotoxicity and otherwise inhibit or reduce incidence or severity of CAR-T-related toxicities in patients undergoing CAR-T cell therapy. Lenzilumab binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF), which has been identified as a key initiator of the inflammatory cascade triggering CAR-T cell therapy-related toxicities, such as CRS and neurotoxicity, which have been associated with prolonged hospitalization and intensive care unit stay.1,2

We believe lenzilumab can potentially play an important role in enhancing CAR-T cell therapy, and we are committed to advancing the development of lenzilumab to address cytokine storm associated with CAR-T cell therapy and other areas, said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. This patent underscores Humanigens pioneering approach to neutralizing GM-CSF with lenzilumab and the value of our robust pipeline across the many disease areas where cytokine storm plays a critical role, including COVID-19 and acute graft-versus-host disease.

The patent, titled Methods of Treating Immunotherapy-Related Toxicity Using a GM-CSF Antagonist, was issued on December 22, 2020 as U.S. Patent No. 10,870,703.

About Humanigen, Inc.

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The companys immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit http://www.humanigen.com.

Forward-Looking Statements

This release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding the use of lenzilumab to treat CAR-T cell therapy-related toxicity, and statements regarding our beliefs relating to any of the other technologies in our current pipeline. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

1 Sterner RM, Sakemura R, Cox MJ, et al. GM-CSF inhibition reduces cytokine release syndrome and neuroinflammation but enhances CAR-T cell function in xenografts. Blood. 2019;133(7):697-709. doi:10.1182/blood-2018-10-881722 2 Fitzgerald JC, Weiss SL, Maude SL, et al. Cytokine Release Syndrome After Chimeric Antigen Receptor T Cell Therapy for Acute Lymphoblastic Leukemia. Crit Care Med. 2017;45(2):e124-e131. doi:10.1097/CCM.0000000000002053

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Humanigen Secures US Patent for Lenzilumab in Preventing Cytokine Storm and Neurotoxicity Related to CAR-T Cell Therapy - BioSpace