FDA Approves Emergency IND Use of Humanigen’s Lenzilumab For Compassionate Use In COVID-19 Patients

Company Provides Drug Free of Charge to Several Leading Centers

• Lenzilumab neutralizes granulocyte macrophage colony stimulating factor (GM-CSF) a key cytokine in the initiation of cytokine storm
• GM-CSF is up-stream of interleukin-6 (IL-6) in the development of cytokine storm
• GM-CSF is up-regulated in COVID-19 patients and may cause a harmful immune response, which contributes to cytokine storm in patients at risk of developing acute respiratory distress syndrome (ARDS)

BURLINGAME, CA / ACCESSWIRE / April 2, 2020 / Humanigen, Inc., (OTCQB:HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s proprietary Humaneered^® anti-human GM-CSF monoclonal antibody, announced that FDA has approved the administration of lenzilumab for COVID-19 patients under individual patient emergency IND applications to patients under the company’s compassionate use program.

The company is advancing plans to conduct a multicenter, Phase III, randomized, double-blinded, controlled, clinical trial with lenzilumab for the prevention of ARDS and/or death in hospitalized patients with pneumonia associated with coronavirus 2 (SARS-CoV-2) infection in COVID-19 patients.

“We are gratified to be able to offer compassionate use of lenzilumab for patients with COVID-19. Humanigen has pioneered the field of GM-CSF neutralization and, unlike other GM-CSF approaches, has already conducted two Phase I and two Phase II studies, including in patients with severe respiratory conditions, with excellent safety results,” said Dr. Cameron Durrant, chief executive officer of Humanigen.

He continued, “Lenzilumab has an excellent safety and tolerability profile and has not been associated with serious adverse events. Prior studies have included patients who are immunosuppressed, as well as patients with severe asthma. We have been working on prevention of cytokine storm for nearly three years. We have published extensively in this field, the mechanism of which has been subsequently reinforced by other companies following our lead in this area. In addition, we have filed extensive IP on GM-CSF neutralization across a wide range of therapeutic areas, including COVID-19.”

More details on the company’s programs in COVID-19 can be found on the company’s website at www.humanigen.com under the COVID-19 tab.

About COVID-19-Induced ARDS

COVID-19 is an infectious disease caused by SARS-CoV-2. COVID-19 has become a global pandemic, with over 940,000 confirmed cases and over 47,000 deaths reported to date. Patients with severe cases of COVID-19 experience severe viral pneumonia that can progress to acute respiratory distress syndrome (ARDS) and death.

ARDS is an acute, life-threatening inflammatory lung injury characterized by hypoxia – a lack of oxygen to the tissue – and stiff lungs due to increased pulmonary vascular permeability. ARDS necessitates hospitalization and mechanical ventilation. A rapid increase in patients with ARDS presents a major challenge for the global public health system given limited hospital beds and ventilators. When implementing standard of care, including mechanical ventilation, ARDS has an overall mortality rate of greater than 40%.

In severe patients infected with COVID-19, published research suggests GM-CSF as the key link between pathogenic Th1 cells and inflammatory monocytes, which secrete additional GM-CSF¹.

Lenzilumab is a late clinical-stage, monoclonal antibody targeting GM-CSF, a pro-inflammatory cytokine up-regulated in the serum of COVID-19 patients². The percentages of certain GM-CSF-expressing cells are significantly higher in the blood of ICU-admitted COVID-19 patients compared with healthy controls and more pronounced in ICU-admitted COVID-19 patients versus non-ICU patients².

1. Zhou Y, Fu B, Zheng X, et al. Aberrant pathogenic GM-CSF+ T cells and inflammatory CD14+CD16+ monocytes in severe pulmonary syndrome patients of a new coronavirus. Pre-Print. 2020. https://doi.org/10.1101/2020.02.12.945576.

2. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497-506. doi:10.1016/s0140-6736(20)30183-5.

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 and ARDS in serious cases of SARS-CoV-2 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 underway 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, which is currently enrolling. 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 expectations for a Phase III study and the future development of lenzilumab to minimize or reduce the severity of lung dysfunction associated with severe COVID-19 infections or to help CAR-T reach its full potential or to deliver benefit in preventing GvHD. 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 conduct the Phase III study and operate our business as a going concern; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development 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.

CONTACT:
Investors and media:
ir@humanigen.com

SOURCE: Humanigen, Inc.

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