SELLAS Life Sciences Highlights Data From Early Study In Blood Cancer Patients

SELLAS Life Sciences Group Inc SLS announced results from its ongoing dose-escalating Phase 1 study of GFH009 in patients with relapsed and/or refractory (r/r) hematologic malignancies.
One patient treated with GFH009 in the 30 mg once-per-week cohort achieved a confirmed complete response (CR), which is the first CR reported in acute myeloid leukemia (AML) with any CDK9 inhibitor monotherapy.
No minimal residual disease (MRD) was detected in this CR patient, and full neutrophil, platelet, and red blood cell recovery were reported.
Related: SELLAS Life Sciences Shares Tumble As Acute Myeloid Leukemia Trial Will Longer Than Anticipated.
Anti-cancer effects were also observed at multiple doses in the r/r AML and r/r lymphoma treatment groups.
Neutrophil counts improved in most patients from both groups while on treatment. Dose-limiting toxicities have not been identified at any levels studied, and the maximum tolerated dose has not yet been reached.
Apparent efficacy was noted without significant toxicities at multiple doses ranging from 9-30 mg.
Stable disease (SD) was maintained in certain patients for more than eight months, and one patient still on treatment has maintained SD for more than a year.
Initial pharmacodynamics (PD) studies have shown evident reductions in two known biomarkers of CDK9 activity, MCL‐1, and MYC.
Price Action: SLS shares are down 4.40% at 2.39 on the last check Tuesday.