Humanigen Announces First Patient Dosed at MedStar Washington Hospital Center in Phase 3 Clinical Study of Lenzilumab in COVID-19

·5-min read
  • New study site actively enrolling eligible hospitalized patients with COVID-19 in clinical trial in Washington, D.C.

Humanigen, Inc. (HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with lenzilumab, today announced that MedStar Washington Hospital Center in Washington, D.C. treated its first COVID-19 patient with lenzilumab. The primary goal of this Phase 3 randomized, double-blind, multicenter, placebo-controlled clinical trial is to determine if lenzilumab can help hospitalized patients with COVID-19 recover faster. As many as 89% of hospitalized patients with COVID-19 are at risk of a complication called cytokine storm, a harmful inflammation that has been the leading cause of COVID-19 death. MedStar Washington Hospital Center is one of 18 sites in the U.S. approved to enroll eligible patients to study lenzilumab, designed specifically to stop this storm. Eligible patients can participate in this trial while also receiving other standard-of-care therapies as recommended by their treating physician.

"Given the growing number of cases in the D.C. area seen in the past few weeks, we were particularly motivated to ensure our Phase 3 study was enrolling and accessible," said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. "We have been impressed with the hospital leadership and trial investigators at MedStar Washington, and worked together with speed and efficiency to get this trial location ready to enroll patients."

For more information on participating in the Phase 3 COVID-19 trial of lenzilumab, please visit StopStorm.com, and talk to your doctor to see if you may be eligible to participate.

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 U.S. Phase 3 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 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). 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 our expectations for the Phase 3 study and the potential future development of lenzilumab, our pathway to our intended submission for, and potential receipt of, an Emergency Use Authorization and potential subsequent BLA from FDA, and statements regarding the potential for lenzilumab to be used to prevent or treat GvHD and, as sequenced therapy with Kite’s Yescarta, in CAR-T therapies. 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; our dependence on partners to further the development of our product candidates; the costs and 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.

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