Therapy Areas: Inflammatory Diseases
Humanigen Aligns with FDA on Potential Registration Phase 3 Study for Lenzilumab with CAR-T
12 January 2022 - - US-based biopharmaceutical company Humanigen, Inc. (NASDAQ: HGEN) has outlined the next steps for the development of its lead candidate, lenzilumab, in the prevention of CAR-T therapy related toxicities including ICANS and CRS in patients with relapsed or refractory Non-Hodgkin lymphoma (rrNHL), the company said.

CAR-T therapies have resulted in significant advances for patients but the clinical benefit observed often comes at a cost. In up to one-third of patients, significant toxicities of ICANS and CRS occur.

Currently, the widespread adoption of CAR-T therapy is limited, in part, by the requirement for treatment in centers that are experienced in managing the common toxicities of ICANS and CRS and by the financial and health burden that this creates.

The SHIELD study will begin recruitment in H1 2022, with preliminary data potentially being shared at the American Society of Hematology congress in December 2022.

Lenzilumab is an investigational product and is not authorized or approved in any country.

Humanigen, Inc. (NASDAQ: HGEN), is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called 'cytokine storm'.

Lenzilumab is a first-in-class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF).

Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm.

Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission.

Humanigen's Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19.

Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19 and CD19-targeted CAR-T cell therapies and is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis.
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