Lenzilumab is under clinical development by Humanigen and currently in the Phase I and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Lenzilumab’s likelihood of approval (LoA) and phase transition for Chronic Myelomonocytic Leukemia (CMML) took place on 20 Dec 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Lenzilumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Lenzilumab overview

Lenzilumab (KB-003) is under development for the treatment of relapsed acute lymphoblastic leukemia (ALL), cute graft versus host disease(GvHD), Coronavirus Disease 2019 (COVID-19) pneumonia and cytokine storm resulting from COVID-19. The drug candidate is administered through intravenous (infusion) route. The drug candidate is an humaneered version of KB-002 (engineered human IgG1 antibody) that acts by targeting soluble GM-CSF. The antibody is developed based on a humaneered technology platform. It was also under development for the treatment of severe asthma, rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), multiple sclerosis, psoriasis and cancer bone destruction, diffuse large b-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL), and follicular lymphoma (FL), chronic myelomonocytic leukemia, juvenile myelomonocytic leukemia (JMML).

It was also under development for the treatment of CAR-T-related neurotoxicity.

Humanigen overview

Humanigen is a biopharmaceutical company that develops proprietary monoclonal antibodies for immunotherapy and oncology treatments. The company offers Ifabotuzumab(anti-EphA3) and Lenzilumab(anti-GM-CSF) recombinant monoclonal antibodies, used for the treatment of solid tumors and their microenvironment, and certain hematologic malignancies such as chronic myelomonocytic leukemia and juvenile myelomonocytic leukemia. It has developed the recombinant monoclonal antibodies using its proprietary drug discovery technology called Humaneered. Humanigen also provides data on on pharmacokinetics and pharmacodynamics including correlative biomarkers and mutational analysis for conducting studies in and juvenile myelomonocytic leukemia. The company has operations in Australia and the UK. Humanigen is headquartered in Burlingame, California, the US.

Quick View Lenzilumab LOA Data

Report Segments
  • Innovator
Drug Name
  • Lenzilumab
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Central Nervous System
  • Immunology
  • Infectious Disease
  • Oncology
  • Respiratory
Key Developers
  • Sponsor Company: Humanigen
  • Originator: Ludwig Institute For Cancer Research
Highest Development Stage
  • Phase III

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.