National Institutes of Health Launches its ACTIV-5 “Big Effect Trial” Evaluating Humanigen’s Lenzilumab™ as Potential COVID-19 Therapy

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™, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), launched its ACTIV-5 “Big Effect Trial” (ACTIV-5/BET), 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. ACTIV-5/BET, which will enroll at as many as 40 US sites, will evaluate lenzilumab with remdesivir, compared to placebo and remdesivir, in hospitalized COVID-19 patients with approximately 100 patients assigned to each study arm. Humanigen is providing lenzilumab for the study, which is fully funded by NIH.

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.

“Lenzilumab is one of the few Phase 3 treatment options in development for COVID-19, and we believe that its mechanism of action as an immunomodulator could work very nicely with remdesivir and potentially enhance first line standard of care therapy to prevent serious and potentially fatal outcomes,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “We are excited at NIH’s recognition of the potential of our drug candidate for this new ACTIV trial, reinforcing the importance of testing and funding for therapeutics to treat COVID-19, and we are eager to put lenzilumab through further rigorous testing to contribute to the battle against this pandemic.”

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.gov using Identifier NCT04583969.

About ACTIV

ACTIV is public-private partnership that has evaluated hundreds of available therapeutic agents with potential application for COVID-19, prioritized the most promising candidates, designed and harmonized five adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates. Master protocols allow coordinated and efficient evaluation of multiple investigational agents as they become available, but within the same clinical trial structure, across multiple study sites. Adaptive protocols swiftly weed out experimental drugs that do not demonstrate effectiveness and identify those that do. Adaptive master protocols reduce administrative burden and cost, provide a flexible framework to rapidly identify drugs that work, and rapidly move additional experimental agents into the trial. In addition to lenzilumab from Humanigen, compounds currently included in the ACTIV protocols include remdesivir from Gilead, LY-CoV555 from Eli Lilly and Company, Apixaban from Bristol Myers Squibb Co. and Eli Lilly and Company, and Risankizumab from Boehringer Ingelheim/AbbVie Inc.

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 as sequenced therapy 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 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 associated with CMC work 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201013005813/en/