Business Wire

The Lancet Respiratory Medicine Publishes Peer-Reviewed Paper and Independent Expert Commentary on Positive Phase 3 Lenzilumab Results

Share

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 today The Lancet Respiratory Medicine (“Lancet”), an internationally trusted, peer-reviewed source of clinical, public health, and global health knowledge, published positive results from Humanigen’s LIVE-AIR Phase 3 randomized, controlled trial of lenzilumab in hospitalized COVID-19 patients, as well as an independent expert commentary. The Lancet paper concludes “LIVE-AIR showed that lenzilumab treatment of hospitalised patients with COVID-19 can improve the likelihood of survival without the need for mechanical ventilation, with a safety profile similar to that of placebo.”2

“Publication of LIVE-AIR results in this peer-reviewed medical journal is a major achievement. Our goal was to demonstrate that lenzilumab, a variant-agnostic therapy, could address the unmet need in treatment of COVID-19 patients by reducing death or mechanical ventilation. The results describe the positive impact lenzilumab has on improving survival without the need for invasive mechanical ventilation in COVID-19 patients upon hospitalization,” said Cameron Durrant, Chairman and CEO, Humanigen. “As the paper describes ‘60% of LIVE-AIR patients were on room air or low-flow oxygen support. … (Raising) the possibility that lenzilumab might be positioned for use before ICU admission and progression of respiratory failure requiring high-flow oxygen and non-invasive or invasive ventilation.’”2

“This study of the treatment to prevent hyperinflammatory immune response that occurs in some patients infected with SARS-CoV-2 is important,” said Zelalem Temesgen, M.D., Mayo Clinic infectious disease researcher and principal investigator. “The need is great for more therapies for newly hospitalized patients prior to respiratory failure to reduce mortality or mechanical ventilation.”

Lenzilumab is not authorized, or approved, in any country.

“One of the key components of the detrimental hyperinflammatory response in COVID-19 is granulocyte-macrophage colony-stimulating factor (GM-CSF). ... excessive GM-CSF production can contribute to the dysregulated immune response in severe COVID-19, in which, upstream of IL-1 and IL-6, activated T cells target neutrophils and macrophages. Agents that interfere with its actions have high plausibility for benefit, not just in COVID-19, but in other acute inflammatory conditions,”1 noted the commentary.

The Lancet paper notes differences in CRP levels for LIVE-AIR patients compared to those of clinical trials for another immunomodulator to suggest these “findings might indicate the therapeutic potential of targeting a single upstream cytokine earlier in the disease process, guided by baseline CRP. ... The study contributes to the emerging body of evidence about how CRP concentrations relate to the pathogenesis of COVID-19 and to patient and treatment selection.”2 Related to the value of a CRP-guided approach to treatment of COVID-19 patients, the commentary noted “further study of a CRP-guided approach, possibly targeting patients with lower CRP concentrations, earlier in their disease course, ... could therefore be warranted.”1

For hospitalized patients, “we now know that targeting the dysregulated host response is of greater value than targeting the virus.”1 The high level of uncertainty and concern surrounding the emergence of the Omicron variant highlights the ongoing need for variant-agnostic therapies.

About the LIVE-AIR, Phase 3 Study of Lenzilumab

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 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 prevent or alleviate the immune-mediated ‘cytokine storm’ and improve survival without ventilation, or ‘SWOV’ (sometimes referred to as ‘ventilator-free survival’). SWOV is a composite endpoint of time to death and time to invasive mechanical ventilation (IMV) and SWOV is an important clinical endpoint that measures not only mortality, but the morbidity associated with mechanical ventilation. Approximately 94% of patients received dexamethasone (or other steroids), 72% received remdesivir, and 69% received both.

The LIVE-AIR study 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; and were hospitalized but did not require IMV. Following enrollment, subjects were randomized to receive three infusions of either lenzilumab or placebo, with each infusion separated by eight hours over a 24-hour period. The LIVE-AIR study achieved its primary endpoint of survival without ventilation measured through day 28 following treatment (HR: 1.54; 95%CI: 1.02-2.32, p=0.040).

About Lenzilumab

Lenzilumab is a proprietary Humaneered® first-in-class monoclonal antibody that has been proven to neutralize GM-CSF, a cytokine of critical importance in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome, or cytokine storm, associated with COVID-19 and other indications. Lenzilumab binds to and neutralizes GM-CSF, consequently improving outcomes for patients hospitalized with COVID-19. Humanigen believes that its GM-CSF neutralization has the potential to reduce the hyper-inflammatory cascade known as cytokine release syndrome common to chimeric antigen receptor T-cell (CAR-T) therapy and acute Graft versus Host Disease (aGvHD).

In CAR-T, lenzilumab successfully achieved the pre-specified primary endpoint at the recommended dose in a Phase 1b study with Yescarta® in which the overall response rate was 100% and no patient experienced severe cytokine release syndrome or severe neurotoxicity. Based on these results, Humanigen plans to test lenzilumab in a randomized, multicenter, potentially registrational, Phase 2 study to evaluate its efficacy and safety when combined with other commercially available CD19 CAR-T therapies in non-Hodgkin lymphoma. Lenzilumab will also be tested to assess its ability to prevent and/or treat aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation.

A study of lenzilumab is also underway for patients with chronic myelomonocytic leukemia (CMML) exhibiting RAS pathway mutations. This study will build on evidence from a Phase 1 study, conducted by Humanigen, that showed RAS mutations are associated with hyper-proliferative features, which may be sensitive to GM-CSF neutralization.

About Humanigen

Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”) is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’. Lenzilumab is a first-in-class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission. Humanigen’s Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19. Humanigen has submitted lenzilumab to Medicines and Health Regulatory Agency in the United Kingdom for a rolling review towards potential Marketing Authorization. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19 and CD19-targeted CAR-T cell therapies and is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis. For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and Facebook.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are 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: Humanigen’s beliefs as to the potential benefits of lenzilumab as a treatment for hospitalized COVID-19 patients; its beliefs as to the potential of lenzilumab to improve patient survival when used before ICU admission and progression of respiratory failure; statements regarding the therapeutic potential of targeting a single upstream cytokine earlier in the COVID-19 disease process; its efforts to request and receive Conditional Marketing Authorization for lenzilumab in COVID-19 in the UK and other territories; and its other plans to initiate or participate in planned clinical trials and otherwise explore the effectiveness of lenzilumab and other candidates in its development portfolio as therapies for other inflammation and immune-oncology indications.

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in the company’s lack of profitability and need for additional capital to conduct its business; its dependence on partners to further the development of its product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; challenges associated with manufacturing and commercializing a biologic such as lenzilumab; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in Humanigen'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 rely upon any forward-looking statements as predictions of future events. The Company undertakes 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.

References

  1. Leavis, H. et al. (2021). Comment: Stimulating severe COVID-19: the potential role of GM-CSF antagonism. The Lancet Respiratory Medicine. https://doi.org/10.1016/S2213-2600(21)00539-7
  2. Temesgen, Z. et al. (2021). Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial. The Lancet Respiratory Medicine. https://doi.org/10.1016/S2213-2600(21)00494-X

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Humanigen Investor Relations
Ken Trbovich
Humanigen
trbo@humanigen.com
650-410-3206

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Dermaliq Therapeutics announces first patient dosed in Phase 1b/2 trial evaluating DLQ02 for treatment of plaque psoriasis18.8.2022 18:27:00 CEST | Press release

Dermaliq Therapeutics, Inc. (Dermaliq), a private, clinical stage pharmaceutical company with a focus on dermatology, today announced first patient dosed in a Phase 1b/2a trial with DLQ02, a topical calcineurin inhibitor. The trial is designed to evaluate the safety, systemic absorption, pharmacodynamics, and clinical efficacy of DLQ02 in patients with plaque psoriasis. “DLQ02 evaluates for the first time hyliQTM, a novel platform technology in dermatology to create best in-class topical therapies with superior bioavailability,” said Betsy Hughes-Formella, PhD, Chief Scientific Officer at Dermaliq. “Calcineurin inhibitors for the treatment of psoriasis are a standard of care when given orally, albeit being associated with significant risk for systemic side effects. DLQ02 is designed to overcome the challenges of topical delivery of this drug class with reduced risk profiles. We are convinced DLQ02 has the potential to transform topical psoriasis therapy for millions of patients.” The r

Aero Secures $65M in Series B Financing to Accelerate the Future of Premium Air Travel18.8.2022 18:00:00 CEST | Press release

Aero Technologies, Inc. the next-generation premium air travel company, which serves routes in both the US and Europe, today announced a $65M capital raise, $50M in Series B funding and $15M in convertible notes, for a total post-money valuation of $300M. The funding round was co-led by AlbaCore Capital Group, one of Europe’s leading alternative investment firms, and returning investors Expa and Keyframe Capital, with new investment from Capital One Ventures. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220818005095/en/ (Photo: Business Wire) Inspired by the golden age of aviation and designed for modern life, Aero is redefining semi-private air travel. Aero serves premium leisure travelers through private terminals, enriching the experience with personalized Concierge services - from booking to touchdown. With its fleet of sleek, black planes, Aero offers elevated, effortless guest experiences to curated destinations with

Veristat is Recognized on the 2022 Inc. 5000 List of America’s Fastest-Growing Private Companies18.8.2022 15:49:00 CEST | Press release

Veristat, global experts in clinical development, registration and post-marketing solutions proudly announces its recognition once again by Inc. Magazine as one of the 5000 fastest-growing private companies in the United States. Since its first appearance on the list in 2015, Veristat has significantly expanded in size, geographic reach and service offering to swiftly guide novel therapies through their clinical development process to regulatory approval and commercialization. Veristat’s team of scientific experts works collaboratively with clients in the biotech and pharmaceutical industries to overcome the many challenges associated with bringing to market products that address current medical shortcomings and maintain their good standing. “Being recognized as one of America’s Fastest-Growing Private Companies is a testament to Veristat’s ability to deliver innovative solutions, bold thinking and versatile engagement models to our clients,” stated Patrick Flanagan, Chief Executive Of

Methane Electrolysis Can Decarbonize LNG/LPG Imports and Achieve EU’s Climate Targets18.8.2022 14:00:00 CEST | Press release

To become independent of Russian natural gas imports by 2027, the European Union is increasing near-term imports of US or Azerbaijan liquefied natural gas (LNG) or liquefied petroleum gas (LPG). The main element of LNG, methane, is the second leading greenhouse gas contributing to climate change. Environmental organizations warn that long-term supply contracts for the fossil LNG will undermine the European Green Deal. The German company Graforce has developed a methane electrolysis technology (plasmalysis) that uses LNG or LPG to produce hydrogen and solid carbon for dioxide-free energy generation. Compared to water electrolysis, plasmalysis requires only one fifth the energy to produce the same amount of hydrogen. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220818005013/en/ Graforce has developed methane electrolysis plants. Errected at LNG terminals or other decentralized locations, they can decarbonize energy supply, a

SoftServe Appoints Rishi Chohan as Executive Vice President of Banking, Financial Services, Insurance, and Retail for North America18.8.2022 13:05:00 CEST | Press release

SoftServe, a leading digital authority and consulting company, announced that Rishi Chohan has joined the company as Executive Vice President of Banking, Financial Services, Insurance, and Retail CPG for North America. Under his leadership, SoftServe will continue to drive innovation through digital transformation for existing and future clients in the financial services and retail industries. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220818005085/en/ SoftServe Appoints Rishi Chohan as Executive Vice President of Banking, Financial Services, Insurance, and Retail for North America (Photo: Business Wire) “SoftServe is well underway to becoming the best-in-class digital authority in the industry, thanks to the incredibly innovative team in North America,” said Chohan. “As we continue to expand, I’m confident that our team will dominate the next generation of financial and retail solutions across cloud, data, artificial in