Humanigen Completes Enrollment in Phase 3 Study of Lenzilumab in Hospitalized Patients with COVID-19

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 it has completed enrollment for its pivotal phase 3 study of lenzilumab for COVID-19. The Company expects to announce top-line data in March 2021.

The primary objective of this Phase 3 randomized, double-blind, placebo-controlled clinical trial, which enrolled 520 patients, is to determine whether lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in hospitalized and hypoxic patients with COVID-19 pneumonia.

“Completing enrollment in this Phase 3 study is a significant milestone in the clinical development of lenzilumab,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “Therapeutics are an important tool alongside vaccines to tackle the coronavirus. We are grateful to the trial participants, their families, investigators and healthcare professionals for their contributions and partnership in continuing to advance the development of lenzilumab.”

Humanigen's investigational treatment lenzilumab, a proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, is designed to prevent and treat cytokine storm, a complication believed to be a cause of the acute respiratory distress syndrome (ARDS) that can result in invasive mechanical ventilation and death in certain COVID-19 patients. Data showed that almost 90 percent of hospitalized patients with COVID-19 are at risk of this immune hyper-response.

More details on Humanigen’s programs in COVID-19 can be found on the company’s website under the COVID-19 tab. Details on this Phase 3 lenzilumab clinical trial can be found at clinicaltrials.gov using Identifier NCT04351152.

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 believes that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. Humanigen’s 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. 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). 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 www.humanigen.com and follow Humanigen on LinkedIn, Twitter and Facebook.