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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.
Lead Product(s): Lenzilumab,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Humaneered
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 12, 2022
Details:
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.
Lead Product(s): Lenzilumab
Therapeutic Area: Infections and Infectious Diseases Product Name: Humaneered
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2022
Details:
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.
Lead Product(s): Lenzilumab,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Humaneered
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: PCI Pharma Services
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 16, 2022
Details:
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.
Lead Product(s): Lenzilumab,GM-CSF
Therapeutic Area: Oncology Product Name: Humaneered
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2022
Details:
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.
Lead Product(s): Lenzilumab
Therapeutic Area: Infections and Infectious Diseases Product Name: Humaneered
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
Details:
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.
Lead Product(s): Lenzilumab
Therapeutic Area: Infections and Infectious Diseases Product Name: Humaneered
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Clinigen Group
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2022
Details:
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.
Lead Product(s): Lenzilumab
Therapeutic Area: Neurology Product Name: Humaneered
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2022
Details:
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.
Lead Product(s): Lenzilumab,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Humaneered
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2021
Details:
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.
Lead Product(s): Lenzilumab,Azacitidine
Therapeutic Area: Oncology Product Name: Humaneered
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2021
Details:
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.
Lead Product(s): Lenzilumab,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Humaneered
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Recipient: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 30, 2021
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