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FIRST PATIENT DOSED IN FDA-APPROVED PHASE III LENZILUMAB STUDY FOR COVID-19
First Phase III pivotal study for an anti-GM-CSF therapy in COVID-19 patients
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First US randomized, double-blind, placebo-controlled, multi-center, Phase III study with an anti-GM-CSF monoclonal antibody which, if successful, may lead to lenzilumab product approval for COVID-19
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Targeting prevention of serious outcomes in adult, hospitalized patients with COVID-19 pneumonia
FDA APPROVES EMERGENCY IND USE OF HUMANIGEN’S LENZILUMAB FOR COMPASSIONATE USE IN COVID-19 PATIENTS
HUMANIGEN PARTNERS WITH CTI, A LEADING CONTRACT RESEARCH ORGANIZATION, FOR PLANNED PHASE III STUDY FOR LENZILUMAB FOR CORONAVIRUS TREATMENT
KITE AND HUMANIGEN ANNOUNCE CLINICAL COLLABORATION TO EVALUATE INVESTIGATIONAL COMBINATION OF YESCARTA® (AXICABTAGENE CILOLEUCEL) WITH LENZILUMAB IN RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA
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GM-CSF has been identified, through clinical correlative analysis and preclinical modeling, as a potential key signal in the inflammatory cascade triggering toxicities associated with chimeric antigen receptor T (CAR T) cell therapy
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Emerging pre-clinical evidence suggests that lenzilumab inhibition of GM-CSF may have the potential to disrupt CAR T cell mediated inflammation without disrupting CAR T cell anti-tumor efficacy
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Phase 1/2 Multi-Center Clinical Trial to Begin Enrolling in Q4 2019
“This collaboration with Kite will help validate the work Humanigen has done in understanding the pathophysiology of the inflammatory cascade as well as the potential role GM-CSF plays in influencing CAR T cell treatment outcomes.”
HUMANIGEN STUDY OF GM-CSF NEUTRALIZATION WITH CAR-T THERAPY SELECTED FOR FRONT COVER OF CURRENT EDITION OF ‘BLOOD’®, THE OFFICIAL JOURNAL OF THE AMERICAN SOCIETY OF HEMATOLOGY (ASH)
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Enhanced anti-tumor activity, improved overall survival, and an exponential increase in CAR-T cell proliferation was observed with GM-CSF neutralization
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Lenzilumab (an anti-GM-CSF antibody) used in combination with CAR-T significantly reduces neuro-inflammation, prevents cytokine release syndrome and improves durable control of leukemic disease
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GM-CSF neutralization with lenzilumab is a next generation strategy to improve efficacy, safety and durability of CAR-T
“This work represents a significant advance in understanding and preventing toxicities after CAR-T cell therapy. Our results strongly suggest that modulating myeloid cell behavior through GM-CSF blockade helps control CAR-T cell mediated toxicities and reduce their immunosuppressive features to improve leukemic control.”
The link to the publication is available for review at:
