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Find Clinical Drug Pipeline Developments & Deals by Humanigen
Humaneered (lenzilumab) is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF), as a treatment for cytokine storm associated with CD19- targeted CAR-T cell therapies.
A sub-analysis of the Phase 3 LIVE-AIR study of Humaneered (lenzilumab) showed a strong correlation between C-reactive protein (CRP) and outcomes with lenzilumab treatment with the greatest clinical benefit experienced by patients with baseline CRP<150 mg/L.
Under the agreement, PCI will purchase Humaneered (lenzilumab), for resale and distribution in the event a Conditional Marketing Authorization is received in the UK for use in patients hospitalized with COVID-19.
CRISPR/Cas9-Mediated GM-CSF knock-out (GM-CSFko) CAR-T cells, lenzilumab, a proprietary Humaneered first-in-class monoclonal antibody demonstrated reduced apoptosis and enhanced in vivo anti-tumor activity in preclinical models.
Lenzilumab, a proprietary Humaneered first-in-class mAB that has been proven to neutralize GM-CSF, a cytokine of critical importance in hyperinflammatory cascade, sometimes referred to as cytokine release syndrome, associated with COVID-19 and other indications.
Humaneered (lenzilumab), is an investigational product that is not currently authorized or approved in any country, now available for certain hospitalized COVID-19 patients through its newly-launched LenzMAP.
FDA Type C meeting and advice creates alignment on registration pathway for Phase 3 SHIELD trial of Humaneered (lenzilumab), which is designed to inform a potential label that reflects both the clinical benefit of lenzilumab and the economic benefit.
Humaneered (Lenzilumab), Phase 3 trial demonstrate treatment of hospitalized COVID-19 patients results in a statistically significant 54% relative improvement in survival without the need for invasive mechanical ventilation.
Humanigen is developing lenzilumab as a treatment for cytokine storm associated with CD19-targeted CAR-T cell therapies and exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease.
Within ACTIV-5, lenzilumab is the first and only anti-human GM-CSF treatment to be tested in ACTIV-5 as a concomitant therapy with remdesivir compared with remdesivir alone.
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