HGEN

Lenzilumab

COVID-19

Phase 3 (Interim Analysis)

Exp Date

September 2020

Amp Volatility Score

Catalyst Info & Data Links

TITLE: Lenzilumab for COVID-19 - Interim Analysis

  • ClinicalTrial.gov (NCT04351152): Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia


WHAT IS THE NEXT CATALYST EVENT?

  • 1) Interim Analysis

  • 2) BLA filing / approval / launch

               See slide 5 of the corporate slide deck at this LINK


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • 1) September 2020 (Q3 2020)

  • 2) December 2020 (Q4 2020)


PRIOR DATA

PRESS RELEASES

COMPETITORS


Granulocyte macrophase colony-stimulating factor (GM-CSF) antibody

  • TJM2 (TJ003234) - I Mab Biopharma

  • Otilimab - GlaxoSmithKline


INDIRECT COMPETITORS


IL-6 antagonists

  • Kevzara - Sanofi and Regeneron

  • Actemra - Roche

MECHANISM OF ACTION / RATIONALE

  • Lenzilumab, a monoclonal antibody that neutralizes granulocyte macrophage colony stimulating factor (GM-CSF)

  • GM-CSF is up-regulated in COVID-19 patients and may cause a harmful immune response leading to acute respiratory distress syndrome (ARDS)

  • Clinical evidence suggests that this harmful immune response contributes to cytokine storm in COVID-19 patients at risk of developing ARDS

  • (Learn more)


Updated by HC

#HGEN, #Lenzilumab , #COVID, #COVID-19, #coronavirus

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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