SELLAS Receives the US FDA’s Orphan Drug Designation to SLS009 for the Treatment of Acute Myeloid Leukemia
Shots:
- The US FDA has granted ODD to SLS009 (selective CDK9 inhibitor) for AML. The designation was based on the P-I study of SLS009. The trial met all key study objectives i.e., anti-tumor activity of ~77.3% bone marrow blast reduction, durable CR with no MRD
- 24 hrs. >IC90 peripheral blood concentrations after 1st infusion with IC90 concentrations resulting in ~97% cancer cell killed, achievement of desired levels of MCL1 & MYC suppression in peripheral blood with reduction in MCL1 or MYC (97%), no DLTs & no higher grade non-hematologic toxicities were seen
- SLS009 is being studied in the P-IIa study. The primary objectives are to evaluate safety, tolerability & efficacy of SLS009 (45mg, qw & at RP2D, 60 mg) + azacitidine & venetoclax with results expected at the end of 2023
Ref: Globe Newswire | Image: Sellas
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