Humanigen Announces First Patient Dosed in NIH ACTIV-5/Big Effect Trial Evaluating Lenzilumab™ for COVID-19

October 29, 2020

  • First patient dosed at the Emory University School of Medicine in Atlanta, Georgia

  • Trial will evaluate lenzilumab with remdesivir, compared to placebo and remdesivir, in up to 200 patients hospitalized with COVID-19


Burlingame, CA, October 29, 2020 Humanigen, Inc., (Nasdaq: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ today announced that the first patient has been dosed at the Emory University School of Medicine in Atlanta, Georgia as part of the in the ACTIV-5 “Big Effect Trial” (ACTIV-5/BET) evaluating lenzilumab with remdesivir, compared to placebo and remdesivir, in patients hospitalized with COVID-19. Lenzilumab is the Company’s lead product candidate and proprietary Humaneered®anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to optimize antibody properties.


ACTIV-5/BET, which is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), is designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19 and, therefore, merit advancement into larger clinical trials.


The adaptive, randomized, double-blind placebo-controlled trial evaluating lenzilumab with remdesivir will include up to 200 patients across as many as 40 treatment centers in the U.S. There will be approximately 100 patients assigned to each study arm.


“Nearly 90% of hospitalized COVID-19 patients progress to severe disease including the cytokine storm for some patients,” said Vincent C. Marconi, MD, professor of medicine and global health in Emory University School of Medicine and Emory’s Rollins School of Public Health. “There is a critical need for a novel COVID-19 therapeutic with potential to reduce patients’ time to recovery, and this study aims to streamline the pathway to finding these urgently needed treatments.”


“We are encouraged by lenzilumab’s efficacy and safety data demonstrated in hospitalized COVID-19 patients to date and believe we have a game-changing treatment with frontline potential,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “We are eager to put lenzilumab through further rigorous testing in this NIH ACTIV-5 study as we continue to advance our lead candidate in the next phases of development.”


ACTIV-5/BET is being conducted in collaboration with the NIH’s public-private partnership Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV) program. The ACTIV partnership has evaluated approximately 400 therapeutic agents with a potential application for COVID-19 and developed a collaborative framework for prioritizing the most promising candidates, streamlining clinical trials, coordinating regulatory processes, and leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics. To date, ACTIV has designed five adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates.


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 on ACTIV-5/BET can be found at www.clinicaltrials.govusing Identifier NCT04583969.


About ACTIV-5/BET


The primary purpose of ACTIV-5/BET, a randomized, double-blind, placebo-controlled trial, is to evaluate the clinical efficacy of the different investigational therapeutics relative to the control arm in hospitalized adults based on the patients’ clinical status at day 8. The study’s secondary point of evaluation is to evaluate the clinical efficacy of the different investigational therapeutics as assessed by the amount of time it takes for each patient to recover from COVID-19.


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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Source: Humanigen, Inc.

Released October 29, 2020

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