Humanigen Inc (HGENQ)

[cowtown jay]

"GM-CSF Inhibitor Lenzilumab Shows Early Promise in CMML
Neil Osterweil

June 19, 2023...

Targeting GM-CSF

'I was very surprised that the RAS-mutant arm — so, patients that have KRAS, NRAS, or CBL mutations — are just responding beautifully to [lenzilumab], and that really has taken me by surprise,' said Daniel Thomas, MD, PhD, from the South Australian Health and Medical Research Institute, Adelaide, Australia, in an interview with Medscape Medical News...''

Thomas is a co-investigator of the ongoing phase 2/3 PREACH-M trial, which is testing a novel strategy of treating CMML with mutations in the RAS pathway with a combination of azacitidine and the investigational antibody lenzilumab, which is a targeted inhibitor of granulocyte-macrophage colony-stimulating factor (GM-CSF).

https://www.medscape.com/viewarticle/993375?form=fpf#vp_1

"In the open label, nonrandomized PREACH-M trial, 72 patients with CMML were enrolled and were assigned to receive 24 monthly cycles of therapy depending on mutational status...

Here at EHA 2023, the investigators reported available data on 10 patients enrolled in the lenzilumab arm and one enrolled in the azacitidine-sodium ascorbate arm.

Among patients in the lenzilumab arm there was a 5.1-fold decrease in monocyte counts (P = .03) and 2.4-fold decrease in blast counts (P = .04) at 12 months of follow-up.

In addition there was a trend toward increased platelet counts over baseline at 12 months, a significant increase in blood hemoglobin concentration (P = .024), a significant reduction in spleen size (P = .03) and a trend toward lower levels of the inflammatory marker C-reactive protein...

Thomas told Medscape that the investigators have been "pleasantly surprised” at how well patients tolerated the monoclonal antibody.

"We haven't had any infusion reactions, we haven't had any pulmonary alveolar proteinosis, we haven't had any fevers from the infusion, from the antibody,” he said."

https://www.medscape.com/viewarticle/993375?form=fpf#vp_2

Thanks to Stocktwits poster paivante69 for referencing the Medscape Medical News article.