CLINICAL-STAGE PIPELINE: LENZILUMAB™ IN COVID-19

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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

CLINICAL-STAGE PIPELINE: NON COVID-19

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