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

Humanizen, Inc. (Nasdaq: HGEN) (“HumaniGen”), a clinical-stage biopharmaceutical company specializing in the prevention and treatment of an overactive immune response called “cytokine shock,” published a peer-reviewed publication today in the journal Peers. announced. Clinico Economics and Outcomes ResearchWhich outlines the potential clinical benefits and health economic benefits of lenzilumab, should it be licensed or approved for use in the UK.

“At a time when COVID-19 continues to place a heavy burden on the National Health Service (“NHS”), this article demonstrates that it is possible for the UK healthcare system to achieve significant cost savings while improving patient outcomes. As a variant-independent treatment, lenazilumab is both a clinically effective and cost-effective option in the fight against current and emerging variants.” said Dr. Adrian Kilcoyne, Medical Director of Humanigen, and lead author of the publication.

The publication demonstrated that lenzilumab plus standard of care improves all specified clinical outcomes compared to standard of care alone in all scenarios. Additionally, patient selection using CRP<150 mg/L as a biomarker has optimized both clinical and economic outcomes. Cost savings were observed primarily as a result of a reduction in the length of hospitalization, a reduction in the number of days under invasive mechanical ventilation, and a reduction in the number of days in intensive care.

The greatest savings in cost per patient were for patients under 85 years of age, with a CRP <150 mg/L, receiving remdesivir, for whom the cost savings were GBP 10,427 (net savings of £3,127 over the acquisition of lenzilumab). Net of cost) as well as Black patients with CRP <150 mg/L, for whom the cost savings were £17,277 (£9 a net saving of £977).

“During these challenging and unprecedented times, we are ready to commercialize lenzilumab, subject to approval or approval, as a day-to-day treatment and a potential driver of clinical and economic value to patients and the health care system. ” said Edward Jordan, commercial director at Humanigen.

This peer-reviewed publication highlights the significant costs of treating hospitalized COVID patients, as well as reducing ventilator use, reducing ventilator use, the number of days hospitalized and the number of days in intensive care. The reason for the numbers highlights the economic benefits of potentially improving ventilator-free survival. The addition of lenzilumab to standard of care.

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

More about lenzilumab

Lenzilumab is a patented, class-leading HumanRed® monoclonal antibody that neutralizes GM-CSF, a key cytokine in the hyper-inflammatory cascade, sometimes referred to as cytokine release syndrome or cytokine shock, caused by COVID-19. -19 and is associated with other signs. Lenzilumab binds to and neutralizes GM-CSF, potentially improving outcomes in patients hospitalized with COVID-19. HumaniGen believes that neutralization of GM-CSF with lenzilumab also provides its ability to reduce the hyper-inflammatory cascade known as cytokine release syndrome, which is associated with chimeric antigen receptor T-cell therapy (chimeric antigen receptor T-cell therapy). antigen receptor, CAR-T) and is common to the acute graft versus host. disease (agVHD).

In CAR-T therapy, lenalilumab successfully achieved the predetermined primary endpoint with Yescarta® at the recommended dosage in the Phase 1B study where the overall response rate was 100%, and where no patient developed severe cytokine release syndrome or severe neurotoxicity. There was no experience. Based on these results, HumaniGen plans to test lenzilumab in a phase 3, randomized, multicenter (“SHIELD”) study, for prospective regulatory purposes, to assess its efficacy and safety when compared with Yescarta and Tecartus CAR. -T treatments with 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 study of lenzilumab in patients with chronic myelomonocytic leukemia (CMML) with RAS pathway mutations is also underway. This study builds on evidence from a phase 1 study by Humanigen, that RAS mutations are associated with hyper-proliferative features, which may be sensitive to neutralization of GM-CSF.

about the human

Humanizen, Inc. (Nasdaq: HGEN) (“HumaniGen”), is a clinical-stage biopharmaceutical company specializing in the prevention and treatment of an overactive immune response called “cytokine shock”. Lenzilumab is a class-leading antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models suggest that GM-CSF is an upstream regulator of several inflammatory cytokines and chemokines involved in cytokine shock. Early in the COVID-19 pandemic, an investigation showed that there was an association between elevated levels of GM-CSF-secreting T cells and disease severity and therefore ICU admission. HumaniGen’s Phase III live-AIR study shows that early intervention with lenzilumab can prevent the consequences of major cytokine shock of COVID-19 in hospitalized patients. In addition to developing lenzilumab as a treatment for cytokine shock associated with COVID-19 and CAR-T cell therapy targeting COVID-19, Humanigen is exploring the efficacy of lenzilumab in other inflammatory conditions, such as acute disease. Graft versus host allogeneic hematopoietic stem cell transplantation in patients undergoing eosinophilic asthma and rheumatoid arthritis. To learn more, please visit www.humanigen.com, and follow us on LinkedIn, Twitter, and Facebook.

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forward-looking statements

All statements except those contained in this press release are forward-looking statements. These reflect management’s current knowledge, beliefs, assessments and expectations regarding future performance or events. Although management believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, it makes no assurance that these expectations will prove to be accurate; Readers are therefore advised that actual events or results could differ materially from those contained in forward-looking statements. The use of words such as “expect”, “intend”, “plan”, “likely”, “possible”, “goal”, “quick”, “continue”, as well as the use of future tenses and similar expressions to identify forward-looking statements Statements about the potential clinical benefits and health economic benefits of lenzilumab, including but not limited to, if authorized for use in the UK as a treatment for COVID-19 or Statements relating to approval, the SHIELD and LIVE-AIR studies, and other statements relating to improvements in safety and efficacy in our plans for CAR-T therapy as well as lenzilumab and ifabotuzumab.

Forward-looking statements are subject to a number of risks and uncertainties, including, without limitation, the risks inherent in our lack of profitability and the need for additional capital to grow our business; our reliance on partners to further develop our product candidates; the uncertainties inherent in developing, obtaining the necessary regulatory clearances and approvals, and launching any new pharmaceutical product; the result of a pending or future trial; and various risks and uncertainties described under “risk factors” in our most recent annual and quarterly reports and other filings with the Securities and Exchange Commission (SEC).

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All forward-looking statements are fully qualified as expressly from this warning statement. Readers are cautioned not to place undue reliance on such forward-looking statements in the context of forecasts or future events. The company undertakes no obligation to revise or update the forward-looking statements contained in this press release to reflect events or circumstances after the date of this press release, to report new information, or to report unforeseen events. Update to reflect events, or reasons that actual results could differ materially from those anticipated in forward-looking statements, in each case, except as required by law.

reference

  1. Kilkoyne, A. At al. (2022). Clinical and economic benefits of lenzilumab plus standard of care compared to standard of care alone for the treatment of patients hospitalized with the coronavirus disease 19 (COVID-19), from the perspective of the National Health Service England. Clinico economics and outcome research. https://doi.org/102147/CEOR.S360741

  2. UK Health Protection Agency. (2022). GOV.UK Coronavirus (COVID-19) in the UK. Data as of 12 April 2022 https://coronavirus.data.gov.uk/details/healthcare . received from

The text of the press release as a result of the translation should not be construed as official in any way. The only authentic version of the press release is that of the press release in its original language. The translation will always have to be compared to the source text, which will set an example.

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