Drug Profile

Lenzilumab - Humanigen

Alternative Names: Humaneered® anti-human GM-CSF monoclonal Antibody; KB-003; LENZ^®

Latest Information Update: 24 Feb 2026

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At a glance

Originator KaloBios Pharmaceuticals
Developer Humanigen; KaloBios Pharmaceuticals; Kite Pharma; National Institute of Allergy and Infectious Diseases; Peter MacCallum Cancer Centre
Class Anti-inflammatories; Antiallergics; Antiasthmatics; Antineoplastics; Antirheumatics; Immunotherapies; Monoclonal antibodies
Mechanism of Action Granulocyte macrophage colony stimulating factor antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes

Preregistration Cytokine release syndrome
Phase II/III COVID 2019 infections; Graft-versus-host disease
Phase II Chronic myelomonocytic leukaemia
Phase I/II Drug hypersensitivity
No development reported Precursor cell lymphoblastic leukaemia-lymphoma; Solid tumours
Discontinued Asthma; B-cell lymphoma; Rheumatoid arthritis

24 Feb 2026 Discontinued - Phase-III for COVID-2019 infections in Australia (IV) (Taran Therapeutics website, February 2026)
06 Dec 2025 Adverse events and efficacy data from a phase II/III PREACH-M in Chronic myelomonocytic leukaemia presented at the 67th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2025)
07 Dec 2024 Updated efficacy and adverse events data from the phase II/III PREACH-M trial in Chronic myelomonocytic leukaemia presented at the 66th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2024)

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