Humanigen’s Lenzilumab as a Potential Therapeutic for Lung Damage Arising From Coronavirus

• Coronavirus triggers cytokine storm in infected patients resulting in severe lung damage and death
• Lenzilumab is in clinical studies for prevention of cytokine storm

BURLINGAME, CA / ACCESSWIRE / March 9, 2020 / Humanigen, Inc., (OTCQB:HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on developing its portfolio of clinical and preclinical therapies for the treatment of cancers and infectious diseases, announced today that it is actively exploring clinical stage strategies and partnerships to evaluate whether lenzilumab, the company’s proprietary Humaneered^® anti-human-GM-CSF monoclonal antibody, may reduce or prevent cytokine storm resulting from COVID-19 (or coronavirus, also referred to as SARS-CoV-2) infection.

A recent pre-publication, titled “Aberrant pathogenic GM-CSF+ T cells and inflammatory CD14+CD16+ monocytes in severe pulmonary syndrome patients of a new coronavirus”, supports the hypothesis that cytokine storm-induced immune mechanism have contributed to patient mortality with the current pandemic strain of coronavirus.

The severe clinical features associated with COVID-19 and other coronaviruses result from an inflammation-induced lung injury requiring intensive care unit (ICU) care and mechanical ventilation. This lung injury is a result of cytokine storm resulting from a hyper-reactive immune response. The lung injury that leads to death is not directly related to the virus, but appears to be a result of a hyper-reactive immune response to the virus triggering a cytokine storm that can continue even after viral titers begin to fall.

The authors of the study assessed samples from patients with severe pneumonia resulting from COVID-19 infection to identify whether inflammatory factors such as GM-CSF, IL-6, IFN-gamma and TNF-alpha were implicated.

The authors noted that steroid treatment in such cases has been disappointing in terms of outcome, but suggest that a monoclonal antibody that targets GM-CSF may prevent or curb the hyper-active immune response caused by COVID-19 in this setting. Humanigen believes that the authors’ findings are clearly worthy of further investigation, suggesting that to reduce or eradicate ICU care and prevent deaths from COVID-19 infection, an intervention may be needed to prevent cytokine storm.

Lenzilumab has been shown to prevent cytokine storm in animal models and this work has been published in peer reviewed publications. Patients are soon expected to be enrolled in a clinical study to determine lenzilumab’s effect on cytokine storm associated with the hyper-active immune response associated with CAR-T therapy in collaboration with Kite Pharma.

Dr. Cameron Durrant, CEO of Humanigen, stated, “These data confirm previously published data from the SARS and the MERS outbreaks, caused by strains of coronavirus different from the current COVID-19 strains, which indicated that severe pneumonia in SARS and MERS resulted from cytokine storm. These new data also suggest that GM-CSF may be a critical triggering cytokine in the increased mortality in the current coronavirus pandemic. Humanigen has pioneered the field of GM-CSF neutralization and published data related to lenzilumab neutralization of GM-CSF and amelioration of cytokine storm in animal models. We have also completed two Phase I and two Phase II studies with lenzilumab, including in patients with severe respiratory impairment where lenzilumab demonstrated benefit.”

Durrant continued, “We expect to commence patient enrollment in the joint Kite Pharma/Humanigen ZUMA-19 study to examine the impact of lenzilumab to reduce cytokine storm, amongst other measures, in the context of CAR-T. With our extensive intellectual property in GM-CSF neutralization, Humanigen is positioned to evaluate lenzilumab’s potential role as part of a response to the coronavirus crisis and is actively exploring clinical stage strategies and partnerships in this regard.”

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 as well as the serious and potentially life-threatening CAR-T therapy-related side effects while preserving and potentially improving the efficacy of the CAR-T therapy itself, thereby breaking the efficacy/toxicity linkage. The company’s immediate focus is to prevent or minimize the cytokine storm that precedes severe lung dysfunction in serious cases of COVID-19 infection and also in combining FDA-approved and development stage CAR-T therapies with lenzilumab, the company’s proprietary Humaneered^® anti-human-GM-CSF immunotherapy, which is its lead product candidate. A clinical collaboration with Kite, a Gilead Company, is expected to commence patient enrollment to evaluate the sequential use of lenzilumab with Yescarta^®, axicabtagene ciloleucel, in a multicenter clinical trial in adults with relapsed or refractory large B-cell lymphoma. 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). The company has established several partnerships with leading institutions to advance its innovative cell and gene therapy pipeline. For more information, visit 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 our efforts to develop lenzilumab to minimize or reduce the severity of lung dysfunction associated with severe coronavirus infections or to help CAR-T reach its full potential or to deliver benefit in preventing GvHD; statements regarding the potential that GM-CSF may be a trigger of the cytokine storm resulting in lung damage or death in patients infected with coronavirus; our expectations for patient enrollment in the ZUMA-19 study with Kite Pharma; and the possibility of attaining a partnership or partnerships to explore lenzilumab’s role in a potential response to the coronavirus crisis. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in Black Horse Capital and its affiliates owning more than 50% of our outstanding common stock, including their ability to control the company; our lack of profitability and need for additional capital to operate our business as a going concern; the uncertainties inherent in the development and launch of any new pharmaceutical product; the lack of control the Company may have over any clinical study commenced with a partner; 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.

CONTACT:

Investors and media:
ir@humanigen.com

SOURCE: Humanigen, Inc.

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