Humanigen to Host Conference Call to Report Phase 3 Topline Results of LenzilumabTM in Patients Hospitalized With COVID-19

Rhea-AI Summary

Humanigen, Inc. (Nasdaq: HGEN) announced a conference call today to discuss topline results from the Phase 3 trial of its leading drug, lenzilumab, for treating hospitalized COVID-19 patients. The randomized, double-blind study aimed to evaluate lenzilumab's effectiveness in enhancing ventilator-free survival alongside standard treatments like dexamethasone. Enrolled were 520 patients across 29 sites in the US and Brazil. Results will be submitted for potential publication in a peer-reviewed journal. For further details, visit www.humanigen.com.

Positive

• Lenzilumab showed potential for improving ventilator-free survival in COVID-19 patients.
• 520 patients enrolled in a well-structured, multi-center Phase 3 clinical trial.
• Comprehensive secondary endpoints evaluated include ICU stay duration and all-cause mortality.

Negative

• None.

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, announced that management will host a conference call and webcast today at 8am ET to discuss topline results from the Phase 3 clinical trial of lenzilumab in patients hospitalized with COVID-19.

Details for the upcoming conference are below:

Webcast link: https://78449.themediaframe.com/dataconf/productusers/hmg/mediaframe/44119/indexl.html

Dial by phone: U.S. 877-405-1224 or Int’l: 201-389-0848.

The webcast will be archived for 90 days under the Investor Relations section of the company’s website at www.humanigen.com.

About the Lenzilumab Phase 3 Study

This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients who were hospitalized with COVID-19 pneumonia. The primary objective was to assess whether lenzilumab, in addition to other treatments, which included dexamethasone (or other steroids) and/or remdesivir, could alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival. Ventilator-free survival is a composite endpoint of time to death and time to IMV, which is a robust measure that is less prone to favor a treatment with discordant effects on survival or days free of ventilation. The trial enrolled 520 patients in 29 sites in the US and Brazil who were at least 18 years of age; experienced blood oxygen saturation (SpO2) of less than or equal to 94%; or required low-flow supplemental oxygen, or high-flow oxygen support, or non-invasive positive pressure ventilation (NIPPV); and were hospitalized but did not require IMV. Following enrollment, subjects were randomized to receive three infusions of either lenzilumab or placebo, each infusion separated by eight hours over a 24-hour period with other treatments. The primary endpoint was the difference between lenzilumab treatment and placebo treatment in ventilator-free survival through 28 days following treatment. Key secondary endpoints, also measured through 28 days, included ventilator-free days, duration of ICU stay, incidence of invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), and/or death, time to death, all-cause mortality, and time to recovery. Results of the trial are planned to be submitted for potential publication in a peer-reviewed journal.

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’s immediate focus is to prevent or minimize cytokine release syndrome that precedes severe lung dysfunction in hospitalized and hypoxic patients with COVID-19 pneumonia. Humanigen is also working to create 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210329005183/en/

FAQ

What were the results of the lenzilumab Phase 3 trial in COVID-19 patients?

The topline results from the Phase 3 trial of lenzilumab are to be discussed in a conference call today.

What is the primary objective of the lenzilumab Phase 3 study?

The primary objective was to assess whether lenzilumab could improve ventilator-free survival in hospitalized COVID-19 patients.

How many patients were involved in the lenzilumab trial?

The trial involved 520 patients across 29 sites in the US and Brazil.

What is the significance of ventilator-free survival in the trial?

Ventilator-free survival is a composite measure assessing both mortality and the need for invasive ventilation.

Where can I find more information about Humanigen?

Visit Humanigen's website at www.humanigen.com for more information.