GM-CSF Gene-Edited CAR-T Data to be Presented at International Society for Cell & Gene Therapy Annual Meeting 2021

Humanigen, Inc. (Nasdaq: HGEN), 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 that granulocyte macrophage-colony stimulating factor (GM-CSF) gene-edited CAR-T data will be presented at the International Society for Cell & Gene Therapy (ISCT) 2021 Annual Meeting which will be held in New Orleans from May 26- 28, 2021.

Researchers at the Mayo Clinic, Rochester, MN have demonstrated that CRISPR/Cas9 GM-CSF knock-out in CAR-T cells (GM-CSF^KO CAR-T) dampens CAR-T cell early activation and reduces activation-induced cell death (AICD), resulting in enhanced antigen-specific T-cell expansion in vivo. The modulation of intrinsic pathways is not due to an off-target effect and provides additional mechanistic rationale for the improved anti-tumor activity observed with GM-CSF^KO CAR-T.

“These findings highlight the intrinsic value of GM-CSF^KO CAR-T as a novel, potentially more effective and less toxic platform to enhance current CAR-T cell therapies,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen.

Mayo Clinic researchers will present their research entitled, “GM-CSF disruption in CAR-T cells ameliorates CAR-T cell activation and reduces activation-induced cell death,” on May 28, 2021 from 11:30 AM to 1:00 PM ET as part of the session titled “Novel Allo-Engineering Approaches and Progress in Off-the-Shelf Products.”

“Mayo Clinic is enthusiastic about these findings, and they provide us with valuable information to enhance our current CAR-T cell therapies,” said Saad S. Kenderian, MD, Division of Hematology, Mayo Clinic.

Details for the upcoming event are below:

ISCT 2021 New Orleans VIRTUAL Meeting

Novel Allo-Engineering Approaches and Progress in Off-the-Shelf Products Session

Date: Friday, May 28, 2021

Time: 11:30 AM ET

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. Humanigen’s immediate focus is on the development of lenzilumab as a therapy for hospitalized, hypoxic COVID-19 patients. Humanigen recently announced plans to initiate a randomized, multicenter, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in diffuse large B-cell lymphoma.

Humanigen 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, Humanigen 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. Humanigen 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). For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter and Facebook.

Forward-Looking Statements

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