National Institute of Allergy and Infectious Diseases (“NIAID”)

COVID-19

NIAID, a part of the National Institutes of Health (“NIH”), which is part of the United States Government Department of Health and Human Services (“HHS”) as represented by the Division of Microbiology and Infectious Diseases (“DMID”), and Humanigen have executed a clinical trial agreement for lenzilumab as an agent to be evaluated in the NIAID-sponsored Big Effect Trial (“BET”) in hospitalized patients with COVID-19.
 
BET will help advance NIAID’s strategic plan for COVID-19 research, which includes conducting studies to advance high-priority therapeutic candidates. Identification of agents with novel mechanisms of action for therapy is a strategic priority.
 
This trial builds on initial data from NIAID’s Adaptive COVID-19 Treatment Trial (ACTT) that demonstrated Gilead’s investigational antiviral, remdesivir, may improve time to recovery in hospitalized patients with COVID-19. BET will evaluate the combination of lenzilumab and remdesivir on treatment outcomes versus placebo and remdesivir in hospitalized COVID-19 patients. The trial is expected to enroll 100 patients in each arm of the study with an interim analysis for efficacy after 50 patients have been enrolled in each arm.
 
With data from the BET and our ongoing Phase III study, we expect to have data from approximately 500 hospitalized COVID-19 patients.

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ACTIV-5/BET clinicaltrials.gov Identifier: NCT04583969

Kite Pharmaceuticals, Inc.

CAR-T Therapies

Our current clinical and regulatory development plan in the CAR-T setting is focused on a collaboration agreement with Kite Pharmaceuticals, Inc., a Gilead company, in May 2019. We are currently enrolling patients for a multi-center Phase 1b/2 study (“ZUMA-19”) of lenzilumab with Kite’s YESCARTA in patients with relapsed or refractory B-cell lymphoma, including diffuse large B-cell lymphoma (“DLBCL”). Kite is the sponsor of ZUMA-19 and is responsible for its conduct. The primary objective of ZUMA-19 is to determine the effect of lenzilumab on the safety of YESCARTA.
 
Kite’s YESCARTA is one of two CAR-T therapies that have been approved by FDA and is the leading CAR-T by revenue. We believe our collaboration with Kite is the only current clinical collaboration that is enrolling patients with the potential to improve both the safety and efficacy of CAR-T therapy. The Kite Agreement is non-exclusive. Depending upon FDA feedback, we believe ZUMA-19 may serve as the basis for registration for lenzilumab in the CAR-T setting.

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ZUMA-19 clinicaltrials.gov Identifier: NCT04314843

IMPACT

GvHD

We are collaborating with IMPACT, a clinical trial partnership of 23 transplant centers in the United Kingdom, in planning a potential randomized, placebo controlled, Phase II/III study focused on early intervention with lenzilumab in patients at high risk or intermediate risk for steroid refractory acute GvHD based on specific biomarkers.  The goal of the trial, as it is currently contemplated, would be to determine the efficacy and safety of lenzilumab in reducing non-relapse mortality at six months. 

C-SMART (COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomized Trial)

Lenzilumab in cancer patients who are COVID-19 positive and have pneumonia

The C-SMART study is led by the National Centre for Infections in Cancer at Peter MacCallum Cancer Centre and will be conducted at five Australian sites in Melbourne and Sydney. This study will include over 1,000 cancer patients at risk of, or known positive for, COVID-19 infection, with a subset of patients in the lenzilumab arm. The study is supported by a grant from the Australian Government's Medical Research Future Fund.

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C-SMART clinicaltrials.gov ID: NCT04534725

PREACH-M (PREcision Approach to CHronic Myelomonocytic Leukaemia)

Lenzilumab in refractory chronic myelomonocytic leukemia (CMML)

Humanigen is in advanced planning for a Phase 2 study of lenzilumab in combination with azacitidine in newly-diagnosed CMML patients who express NRAS/KRAS/CBL mutations, which are known to be hypersensitive to granulocyte macrophage-colony stimulating factor (GM-CSF) and therefore may lend themselves to responsiveness to lenzilumab treatment. CMML is a rare form of hematologic cancer with no FDA-approved treatment options and a three-year overall survival rate of 20% and median overall survival of 20 months.[1,2] The study is funded by grant from the Australian Government's Medical Research Future Fund and is expected to commence in 2021.

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[1] Patnaik MM, Tefferi A. Chronic Myelomonocytic leukemia: 2020 update on diagnosis, risk stratification and management. Am J Hematol. Jan 2020;95(1):97-115. doi:10.1002/ajh.25684

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[2] Coston T, Pophali P, Vallapureddy R, et al. Suboptimal response rates to hypomethylating agent therapy in chronic myelomonocytic leukemia; a single institutional study of 121 patients. Am J Hematol. Jul 2019;94(7):767-779. doi:10.1002/ajh.25488

Ifabotuzumab in glioblastoma multiforme (GBM)

This Phase 1 trial has enrolled 11 of the 12 patients targeted for full enrollment. Results are expected to be available in the first half of 2021.

Professor Andrew Scott, Head, Tumour Targeting Laboratory, Olivia Newton-John Cancer Research Institute, and Professor, School of Cancer Medicine, La Trobe University, who has been instrumental in the research and development of both lenzilumab and ifabotuzumab, said, "The establishment of Humanigen Australia Pty Ltd speaks to the importance and culmination of 20 years of research for these two novel antibodies, which we helped discover and develop in Australia. We hope that lenzilumab will have a major impact in the treatment of COVID-19 patients. Ifabotuzumab holds promise as a novel approach to target the tumour microenvironment in a range of solid tumors."

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Ifabotuzumab in GBM clinicaltrials.gov ID: NCT03374943