Lenzilumab COVID-19 Case-Control Study Published in Mayo Clinic Proceedings Journal

September 1, 2020

  • 80% reduction in relative risk of invasive mechanical ventilation and/or death in patients treated with lenzilumab compared to the control group

  • Median time to resolution of acute respiratory distress syndrome (ARDS) reduced to one day for patients treated with lenzilumab versus eight days in control group

  • Lenzilumab patients discharged from the hospital in less than half the time compared with control group


Burlingame, CA, August 31, 2020 Humanigen, Inc., (HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ today announced the first case-control data of lenzilumab in severe COVID-19 demonstrating an 80% reduction in relative risk of invasive mechanical ventilation (IMV) and/or death for patients treated with lenzilumab compared to the matched control group. Lenzilumab, the company’s proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody drug candidate, is being evaluated in an ongoing Phase III trial and was selected by the National Institutes of Health for its COVID-19 Big Effect Trial. The manuscript, titled “GM-CSF neutralization with lenzilumab in severe COVID-19 patients: A case-control study” was published in Mayo Clinic Proceedings, a premier peer-reviewed journal.


“We believe these to be some of the most compelling data published to date of an investigational therapeutic with potential to substantially fight the COVID-19 pandemic and we look forward to validating these data with the results of our ongoing Phase III study,” said Dale Chappell, MD, MBA, chief scientific officer of Humanigen. “We also appreciate that the stakes are even higher after some other pathways being explored across the industry haven’t met their clinical endpoints and rates of infection are increasing in many areas.”


The study involved a total of 39 patients, including 12 treated with lenzilumab, and 27 contemporaneous matched control patients who received standard of care treatment. Lenzilumab treatment was associated with a reduction in risk of progression to IMV and/or death compared to matched controls (8% vs. 41%, p=0.07). Median time to resolution of acute respiratory distress syndrome (ARDS) was one day in the lenzilumab treatment arm versus eight days in the control group (p<0.001). Patients treated with lenzilumab were discharged in a median of five days versus 11 days in the control arm (p=0.008).


Lenzilumab treatment was also associated with a significant reduction in the inflammatory marker c-reactive protein (CRP) relative to the control group (p=0.01) and an improvement in lymphocyte counts relative to the control group (p=0.04). These data suggest that GM-CSF neutralization with lenzilumab may restore balance to the dysregulated immune response induced by SARS-CoV-2 by supressing the myeloid inflammatory response and improving T-cell counts that are thought to be responsible for viral clearance. There were no treatment-emergent adverse events attributable to lenzilumab.


“Based on the pathophysiology of an immune hyper-response or cytokine storm following SARS-CoV-2 infection, these data along with prior studies conducted at Mayo Clinic on GM-CSF depletion point to the potential impact of treating cytokine storm in COVID-19 with lenzilumab,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “As vaccine development continues to progress and we await compelling data, we must also look toward nearer-term achievable goals, such as bringing effective treatments to hospitalized COVID-19 patients this winter. Having a therapeutic that can reduce the risk of ventilation and death from COVID-19 would have a dramatic impact on the arc of the current pandemic both nationally and globally, and potentially help re-set societal response to the pandemic.”


Control patients were identified from an electronic registry of COVID-19 patients in the same centers as cases and matched for age, sex, disease severity, and baseline oxygen requirements. At the time of selection, the clinical outcomes of the controls were not known.


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, and details of the US Phase III potential registration study 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. 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 ARDS in serious cases of SARS-CoV-2 infection. 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, 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.


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 the potential impact of treating cytokine storm in COVID-19 with lenzilumab; the possibility that bringing effective treatments to hospitalized COVID-19 patients this winter, including a therapeutic that could reduce the risk of ventilation and death from COVID-19, could have a dramatic impact on the arc of the current pandemic both nationally and globally, and potentially help re-set societal response to the pandemic; our belief that the results from the pending Phase III clinical trial of lenzilumab will validate the results of the case-controlled study conducted by the Mayo Clinic; and our belief that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with COVID-19 infection . Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to conduct the Phase III study and other clinical development programs and grow our business; 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.


CONTACTS:

Media

Sean Leous

Westwicke, an ICR company

sean.leous@westwicke.com

646-866-4012


Investors

Victoria Meissner, MD

Westwicke, an ICR company

victoria.meissner@westwicke.com

646-677-1837


Source: Humanigen, Inc.

Released September 1, 2020

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