Humanigen announces peer-reviewed publication demonstrating the potential clinical and economic benefits of lenzilumab from an NHS perspective

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  • In a weekly cohort of 4,754 newly hospitalized patients, adding lenzilumab to standard of care (SOC) could result in over £5.5m in weekly savings1

  • Lenzilumab plus SOC resulted in cost savings per patient of between £8,462 and £17,277 (net savings of £1,162 to £9,977) depending on patient population1

  • The number of COVID-19 cases continues to remain high with around 20,000 patients currently in hospital in the UK,2 demonstrating the urgent need for clinically effective and cost-effective treatments for hospitalized patients

SHORT HILLS, NJ, April 19, 2022–(BUSINESS WIRE)–Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called “cytokine storm,” today announced a peer-reviewed publication in Clinical Economics and Outcomes Research outlining the potential clinical and economic benefits of lenzilumab, if licensed or approved for use in the UK.

“As COVID-19 continues to place a significant burden on the National Health Service (“NHS”), this article demonstrates that there is an opportunity to make significant savings to UK health systems while improving patient outcomes treatment, lenzilumab may offer a clinically effective and cost-effective option against current and emerging variants,” said Adrian Kilcoyne, MD, Chief Medical Officer, Humanigen, senior author of the publication.

The publication demonstrated, in all cases, that lenzilumab plus SOC improved all specified clinical outcomes compared to SOC alone. In addition, patient selection, using CRP

The largest cost savings per patient were for patients aged

“During these unprecedented and challenging times, we are preparing to commercialize lenzilumab, if licensed or approved, as a day-ahead treatment and as a potential driver of clinical and economic value for patients and the system. healthcare,” said Edward Jordan, Chief Commercial Officer, Humanigene.

This peer-reviewed publication highlights the significant costs of treating hospitalized patients with COVID-19 and the economic benefits of potentially improving ventilator-free survival, reduced ventilator use, hospital days. hospitalization and intensive care days that may be associated with adding lenzilumab to the standard of care.

Lenzilumab is an investigational product and is not approved or licensed in any country.

About lenzilumab

Lenzilumab is Humaneered®’s first-in-class, proprietary monoclonal antibody that has been shown to neutralize GM-CSF, a critically important cytokine in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome or storm of cytokines, associated with COVID-19 and other clues. Lenzilumab binds to and neutralizes GM-CSF, potentially improving outcomes for patients hospitalized with COVID-19. Humanigen believes that neutralizing GM-CSF with lenzilumab also has the potential to reduce the hyper-inflammatory cascade known as cytokine release syndrome common to chimeric antigen receptor (CAR-T) T-cell therapy and acute graft versus host disease (aGvHD).

In CAR-T, lenzilumab successfully met 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 patients presented with severe cytokine release syndrome or severe neurotoxicity. Based on these results, Humanigen plans to test lenzilumab in a Phase 3 randomized, multicenter, potentially registrational (“SHIELD”) study to assess its efficacy and safety when combined with Yescarta and Tecartus CAR therapies. -T in non-Hodgkin’s 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 lenzilumab study is also underway for patients with chronic myelomonocytic leukemia (CMML) with RAS pathway mutations. This study builds on evidence from a Phase 1 study, conducted by Humanigen, which showed that RAS mutations are associated with hyperproliferative characteristics, 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 a “cytokine storm”. Lenzilumab is a first-in-class antibody that binds and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate that GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in cytokine storm. Early in the COVID-19 pandemic, investigation showed that elevated levels of GM-CSF-secreting T cells were associated with disease severity and intensive care unit admission. Hunigen’s LIVE-AIR Phase 3 study suggests that early intervention with lenzilumab could prevent the consequences of a true cytokine storm in hospitalized patients with COVID-19. Humanigen is developing lenzilumab as a treatment for the cytokine storm associated with CAR-T cell therapies targeted at COVID-19 and CD19 and is also exploring the efficacy of lenzilumab in other inflammatory conditions such as acute graft versus graft disease. host 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, judgments and expectations regarding future performance or events. Although management believes that the expectations reflected in these statements are reasonable, it does not guarantee that these 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, but not limited to, statements regarding the potential clinical and economic benefits of lenzilumab, if cleared or approved for use in the UK as a therapy for COVID-19, statements regarding the SHIELD and LIVE-AIR studies, and other statements regarding improving the safety and efficacy of CAR-T and our plans for lenzilumab and ifabotuzumab.

Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, risks inherent in our lack of profitability and our need for additional capital to grow our business; our reliance on partners to further develop our product candidates; the uncertainties inherent in developing, obtaining required regulatory clearances and approvals, and launching 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 most recent annual and quarterly reports and other filings with the SEC.

All forward-looking statements are expressly qualified in their entirety by this cautionary statement. You should not rely on forward-looking statements as predictions of future events. 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, to reflect new information or the occurrence of unforeseen events, or to update the reasons why actual results could differ materially. of those anticipated in the forward-looking statements, in each case, except as required by law.

References

  1. Kilcoyne, A. et al. (2022). Clinical and economic benefits of lenzilumab plus standard of care versus standard of care alone for the treatment of hospitalized patients with coronavirus disease 19 (COVID-19) from the perspective of the National Health Service England. Research on clinical economics and outcomes. https://doi.org/10.2147/CEOR.S360741

  2. UK Health Security Agency. (2022). GOV.UK Coronavirus (COVID-19) in the UK. Retrieved April 12, 2022 from https://coronavirus.data.gov.uk/details/healthcare

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contacts

Investor Relations
Ken Trbovitch
Humanity
[email protected]
650-410-3206

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