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NIH Selects Humanigen’s Lenzilumab for its COVID-19 Big Effect Trial (BET), Sponsored by NIAID to Advance High-Priority Therapeutic Candidates for COVID-19; Humanigen’s Monoclonal Antibody Will Be Tested in Combination with Gilead’s Antiviral Remdesivir

On July 27, 2020, Humanigen, Inc., (HGEN) (https://www.humanigen.com/), a clinical-stage biopharmaceutical company focused on preventing and treating “cytokine storm,” announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), which is part of the United States Government Department of Health and Human Services (HHS) as represented by the Division of Microbiology and Infectious Diseases (DMID), and Humanigen have executed a clinical trial agreement for lenzilumab, the company’s proprietary Humaneered®anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody drug candidate, as an agent to be evaluated in the NIAID-sponsored Big Effect Trial (BET) in hospitalized patients with COVID-19. BET will help advance NIAID’s strategic plan for COVID-19 research, which includes conducting studies to advance high-priority therapeutic candidates.1 Identification of agents with novel mechanisms of action for therapy is a strategic priority. This trial builds on initial data from NIAID’s Adaptive COVID-19 Treatment Trial (ACTT) that demonstrated Gilead’s investigational antiviral, remdesivir, may improve time to recovery in hospitalized patients with COVID-19. BET will evaluate the combination of lenzilumab and remdesivir on treatment outcomes versus placebo and remdesivir in hospitalized COVID-19 patients. The trial is expected to enroll 100 patients in each arm of the study with an interim analysis for efficacy after 50 patients have been enrolled in each arm. “We have been encouraged by the lenzilumab efficacy and safety data demonstrated in the compassionate use series in COVID-19 patients and are thrilled that NIH selected lenzilumab to be part of its Big Effect Trial,” said Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen. “With data from the BET and our ongoing Phase III study, we will have data from approximately 500 hospitalized COVID-19 patients.” Experience with SARS-CoV-2 indicates that infection of the respiratory tract is rapid. and damage is primarily mediated by the host inflammatory response. These conditions may make it difficult to modify COVID-19 with a pathogen-directed therapeutic. Host-directed strategies that target the immune response may exert additional therapeutic benefit. Having previously published data demonstrating the ability of lenzilumab to prevent and/or treat “cytokine storm,” Humanigen believes lenzilumab may be synergistic in the treatment of patients with COVID-19, when used in combination with a direct-acting antiviral, like remdesivir, given the differing mechanisms of action. More details on Humanigen’s programs in COVID-19 can be found on the company’s website at www.humanigen.com under the COVID-19 tab (https://www.humanigen.com/covid-19) and details of the US Phase III potential registration study can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04351152 (https://clinicaltrials.gov/ct2/show/NCT04351152).

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 granulocyte macrophage-colony stimulating factor (GM-CSF)neutraliz ation 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 company’s immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and acuter respiratory distress syndrome (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, 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.

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 (https://www.kitepharma.com/), 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 www.humanigen.com.

[Humanigen press release] [Humanigen]
[NIAID Strategic Plan for COVID-19 Research FY2020--FY2024. National Institute of Allergy and Infectious Diseases. April 22, 2020]