BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc. (Nasdaq: HGEN), 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 the European Commission identified lenzilumab as one of the “10 most promising treatments for COVID-19” in a report and press release issued on October 22, 2021.1,2
“We are gratified the European Commission has recognized the potential of lenzilumab to offer an important treatment option for patients hospitalized with COVID-19,” said Cameron Durrant, MD, Chairman and CEO, Humanigen. “We look forward to continuing our discussions with colleagues at the European Medicines Agency to advance our efforts to submit a marketing authorization application for lenzilumab in COVID-19. We are also progressing with our early access program, under compassionate use, where allowed by regulations in some European countries and the United States.”
*Lenzilumab is not authorized, or approved in any country, and as the European Commission notes, the selection of lenzilumab as a top-10 candidate “does not replace the scientific assessment by the European Medicines Agency, or the authorisation . . . by the European Commission.”2
Lenzilumab was chosen as one of the 10 most promising COVID-19 treatments after an evaluation of 82 late-stage therapeutic candidates by an independent group of 10 scientific experts across Europe. As described in the report, “these experts focused on the products with the highest potential impact on the pandemic.”1 Lenzilumab was one of only four immunomodulators selected that treats hospitalized patients. Although several other immunomodulators targeting GM-CSF were evaluated, lenzilumab is the only immunomodulator that targets GM-CSF to be selected by the European Commission for inclusion as one of the 10 most promising treatments for COVID-19.1
“We are pleased the report prepared by the European Commission’s independent experts recognizes the additional clinical value and reassuring safety profile of lenzilumab,” said Adrian Kilcoyne, MD, MPH, Chief Medical Officer, Humanigen. “The report also recognizes that lenzilumab is variant agnostic, a critically important consideration in the public health context.”
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=0.0403). Results of the trial have been submitted for publication in a peer-reviewed journal.
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 (“CRS”) or cytokine storm (CS), associated with COVID-19 and other indications. Lenzilumab binds to and neutralizes GM-CSF, consequently improving outcomes for hypoxic 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 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 DLBCL. Lenzilumab will also be tested to assess its ability prevent and/or treat aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
A study of lenzilumab is also being prepared 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.
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 acute Graft versus Host Disease 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.
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 our plans to submit a marketing authorization application to the European Medicines Agency, statements regarding the potential of lenzilumab being authorized for use by the European Commission; statements regarding the potential of lenzilumab to offer treatment benefits and potential improvement in mortality in patients hospitalized with COVID-19; statements regarding safety of lenzilumab; and statements regarding our plans to develop lenzilumab for CAR-T and other indications and our other plans relating to lenzilumab.
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 and need for additional capital to grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals 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 of our latest annual and quarterly reports and other filings with the SEC.
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. We undertake no obligation to revise or update any forward-looking statements made in this presentation 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.
- European expert group on SARS-CoV-2 variants, COVID-19 therapeutics sub-group. COVID-19 therapeutics portfolio – list of ten most promising candidates (2021). European Commission. Retrieved October 23, 2021, from https://ec.europa.eu/transparency/expert-groups-register/core/api/front/document/59939/download
- European Health Union: Commission establishes portfolio of 10 most promising treatments for COVID-19. (2021, October 22). European Commission Press Corner. Retrieved October 23, 2021, from https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5366