CLINICAL-STAGE PIPELINE: LENZILUMAB™ IN COVID-19
Indication
Phase
Centers
Status
Partners
Lenzilumab
18 US
Up to 12 Brazil
Up to 5 Mexico
Company Sponsored
Up to 40 sites
NIAID/DMID Sponsored
Potential Registration Enabling
Prevention / treatment of Hyper-inflammation / Cytokine Storm
Phase 3
Recruiting
300 patients
(>50% enrolled)
ACTIV-5/
BET
Prevention / treatment of Hyper-inflammation / Cytokine Storm
Phase 2
Recruiting
200 patients
Lenzilumab
Ifabotuzumab
HGEN005
Indication
Phase
Status
Centers
Partners
47 sites
3
Undisclosed
Up to 23 sites
2
10 sites
Including MD Anderson and other ZUMA-1 sites
ZUMA-19
Break CAR-T Efficacy/Toxicity Linkage
Lenz prophylaxis as sequenced therapy with Yescarta in r/r DLBCL
Phase 1b/2
1
Recruiting
Chronic myelomonocytic leukemia (CMML)
Lenz + azacitidine in NRAS, KRAS or CBL mutant-positive newly-diagnosed patients
Phase 2
Advanced planning
Prevention/Treatment of Acute GvHD
Allogeneic HSCT
Phase 2/3
Advanced planning
Eosinophilic Asthma (EA)
Lenz in inadequately controlled asthma
Phase 2
Completed, seeking partner for Phase III
CMML
Lenz monotherapy in salvage patients
Phase 1
Completed
4
Solid Tumors
(Glioblastoma Multiforme)
Phase 1
Active, almost fully recruited
EA and other eosinophilic diseases
Preclinical
Initiating IND-enabling studies
1 Phase III may not be necessary for approval in ZUMA-19; precedent is CAR-Ts to date have been approved on Phase II data
2 UK
3 US, EU, Australia
4 Australia