Humanigen's Lenzilumab Shows Encouraging Response Rate In Blood Cancer Study

Humanigen Inc HGEN has announced data from the Phase 1b portion of the ZUMA-19 trial evaluating its lead candidate lenzilumab in patients treated with CAR-T in diffuse large B-cell lymphoma (DLBCL).
ZUMA-19 study designed to evaluate the efficacy and safety of lenzilumab and CAR-T (axicabtagene ciloleucel, Axi-Cel).
In the six study patients, the ORR was 83% (n=5), including four complete responses (CR).
In cohort 1, there was no severe cytokine release syndrome (CRS). One patient experienced severe neurotoxicity (NT) with a two-day duration.
At the recommended Phase 2 dose of 1,800 mg, the ORR was 100%, and no patient experienced severe cytokine release syndrome (CRS) or severe neurotoxicity (NT).
There were no adverse events attributed to lenzilumab across the study.
Inflammatory markers were correlated with reduced rates of CRS and NT. Lenzilumab dose-dependently reduced myeloid cytokines and systemic inflammatory markers.
The company now plans to start a Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in DLBCL.
The study plans to enroll approximately 150 patients, and the protocol is being submitted to FDA.
Additionally, Humanigen has terminated the clinical collaboration agreement with Kite Pharma, a Gilead Sciences Inc GILD company related to ZUMA-19. Both parties will collaborate to wind down the current study activities.
Price Action: HGEN shares are down 1.56% at $14.73 in the premarket hours on the last check Monday.

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