Stage (next event)
Phase 1b (Results)
Catalyst Info & Data Links
TITLE: Lenzilumab for Relapsed or Refractory Large B-Cell Lymphoma - Phase 1b Results
ClinicalTrial.gov (NCT04314843): Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma (ZUMA-19)
WHAT IS THE NEXT CATALYST EVENT?
1. Phase Ib results
2. Phase II interim analysis
3. Six-month efficacy data
See slide 8 of the corporate slide deck at this LINK
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
1. December 2020 (Q4 2020)
2. H1 2021
3. H2 2021
07-2020: Corporate Presentation (slides 5, 17-18)
2018: Graft-versus-host disease, but not graft-versus-leukemia immunity, is mediated by GM-CSF–licensed myeloid cells. Science translational medicine, 10(469).
2019: Donor T-cell–derived GM-CSF drives alloantigen presentation by dendritic cells in the gastrointestinal tract. Blood advances, 3(19), 2859-2865.
2019: GM-CSF inhibition reduces cytokine release syndrome and neuroinflammation but enhances CAR-T cell function in xenografts. Blood, The Journal of the American Society of Hematology, 133(7), 697-709.
2020: A new role for an old cytokine: GM-CSF amplifies GVHD. Blood, 135(8), 520-521.
Mechanism of Action
MECHANISM OF ACTION / RATIONALE
Lenzilumab is a proprietary Humaneered® (“Humaneered”) anti-human granulocyte-macrophage colony-stimulating factor (“GM-CSF”) monoclonal antibody. Lenzilumab is a monoclonal antibody that has been proven in animal models to neutralize GM-CSF, a cytokine that we believe is of critical importance in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome (“CRS”) or cytokine storm, associated with COVID-19, chimeric antigen receptor T-cell (“CAR-T”) therapy and acute Graft versus Host Disease (“GvHD”) associated with bone marrow transplants. Lenzilumab binds to and neutralizes GM-CSF.
Updated by HC
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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